FDA Week InsideHealthPolicy.com’s

InsideHealthPolicy.com’s
FDA Week
an exclusive weekly report on Food and Drug Administration policy, regulation and enforcement
Vol. 20, No. 43 — October 24, 2014
European Biosimilars Makers To WHO: Scrap BQ Idea Unless Study Done
The European Generic Medicines Association is urging the World Health Organization not to pursue its biological
qualifier naming scheme unless it generates different options, discusses them publicly and sets up an independent usertest of the different possibilities, according to a summary of the group’s stance conveyed to WHO last week. European
and domestic biosimilar developers have been pressing for the use of company names, instead of a series of random
letters, to more easily differentiate among biologics if regulators decide to pursue a distinguishable naming scheme for
biosimilars and biologics.
continued on page 4
FDA, Industry: Response To Ebola Is Not Replicable For All Rare Diseases
FDA’s top official and a key biotechnology trade group official warned this week that the agency’s Ebola response,
including allowing the early use of investigative therapies, might not be applicable in all cases of rare diseases. FDA
Commissioner Margaret Hamburg also said it is unlikely Ebola vaccines in development would receive orphan drug
designation since they would be administered to a broad population, but touted the agency’s recent efforts to accelerate
access to investigative new Ebola drugs as an example of FDA’s flexibility in reviewing treatments for rare diseases.
Pharmaceutical companies and rare disease groups are watching FDA’s response to the West African Ebola outcontinued on page 6
Drug Exclusivity, Incentives On The Table As House ‘Cures’ Effort Advances
The brand drug industry and some patient groups have lined up proposals for added drug exclusivity as House
lawmakers consider medical product development and regulatory reforms outside the Prescription Drug User Fee Act
negotiation process, but generic drug makers, AARP and a key House Democrat urge Congress to tread carefully.
Energy and Commerce health panel chair Joe Pitts (R-PA) recently said company incentives could be included in an
upcoming bill stemming from the committee’s 21st Century Cures initiative, and stakeholders are pushing added
exclusivity for a range of cases such as for small molecule drugs and first-in-class treatments.
continued on page 8
In wake of FDA settlement...
CFS Will Consider Second Lawsuit If FDA Finalizes GRAS Rule Unchanged
If FDA finalizes a long-unfinished Generally Recognized as Safe (GRAS) rule — as required by a recent settlement
— but does not make any changes to “ensure the safety of the public food supply,” more legal action could follow, said
an attorney with the Center for Food Safety, whose lawsuit prompted the settlement. The action also offers the agency an
opportunity to revisit new ideas for GRAS reform that have emerged since the rule was originally proposed in 1997, one
attorney said.
continued on page 10
Chamber Report Pushes Legal Reforms To Curb Massive Drug Settlements
Monetary restrictions on settlements that result from government legal action against corporations could curb the
rise in million-and billion-dollar settlements, according to a report from the U.S. Chamber of Commerce’s Institute for
Legal Reform, which poses several other possible reforms. The report cites drug manufacturers among the targets of
legal action generated by attorneys general, the plaintiffs’ bar and the federal government in recent years.
The report, released Tuesday (Oct. 21), describes problems with “swarm litigation,” which occurs when multiple
enforcement authorities — such as attorneys general, various federal agencies, state agencies and private law firms hired
continued on next page
by states — have overlapping jurisdictions and take legal action against a company. The trend has occurred in several
industries, including drug companies, according to the report, which floats possible solutions like allowing only one
government agency to take action and establishing standards for determining monetary sanctions.
Report author Andrew Pincus, a partner at Mayer Brown, said the ideas floated in the report are in the early phases of
being discussed and there has not been any legislative action so far. The report asserts that government officials’ interests
influence enforcement decisions, companies often settle because of the risk and cost of defending the case, and settlements often impose new regulatory regimes outside the lawmaking or rulemaking process.
“The recent settlements relating to off-label pharmaceutical marketing provide an example of the disproportionate pressure
that can force billion-dollar settlements, notwithstanding the complete rejection of liability by other courts,” according to the
report. “During the past 10 years, State AGs, regulators, and plaintiffs’ lawyers have simultaneously pursued overlapping
actions against large pharmaceutical companies based on the alleged off-label promotion of their products.”
The Department of Justice has investigated companies under labeling laws and the False Claims Act, causing
enforcement pressure that has “resulted in truly unprecedented monetary settlements,” the report notes.
In addition to monetary restrictions on settlements and preventing multiple agencies from taking action, the report
recommends limiting enforcement actions to situations where the statute and regulation are clear, and preventing state
authorities from entering into settlements that regulate conduct in other states. The report also proposes to regulate the use of
outside counsel through contingency fees by prohibiting government delegation to private parties, being transparent about fee
arrangements with outside counsel, limiting the size of fees, and increasing oversight and accountability.
While talk of broader legal reforms are in the early stages, drug companies have been pressuring FDA for
clearer policies on off-label promotion. Further, the House Energy and Commerce Committee has been weighing
reforms aimed at medical product development and regulation and some stakeholders view the congressional effort as an
opportunity to weigh into these long-debated drug company communication policies.
“The FDA’s restrictions on communication about medically accepted new uses of approved medicines should be
revisited in order to provide all healthcare professionals, including those in rural areas, with scientifically accurate, datadriven information that can help patients,” Pharmaceutical Research and Manufacturers of America suggested to the
committee earlier this year.
PhRMA asked Congress to press FDA to revise its regulations. So long as it’s truthful, scientifically accurate and
data driven, companies should be able to share: analyses of real-world drug usage based on patient records,
pharmacoeconomic information, subpopulation information from clinical trials, observation and comparative data
information from drug use outside clinical trials and information on medically accepted alternative uses, PhRMA said.
Similarly, AstraZeneca asked the committee to “direct FDA to establish clear and comprehensive guidance”
regarding permissible company communications with payers and similar entities. The committee also should include
specific time frames to ensure the agency prioritizes these policies, the company said. — Alaina Busch McBournie
Medical Device Recall, Enhancement Guide Removes Reporting Requirement
FDA’s recently finalized guidance that tells medical device companies how to distinguish a recall from an enhancement, with the agency removing a controversial section that extended new reporting requirements to companies that make
enhancements to their products. One expert said FDA took great strides in clarifying the topic for stakeholders, but an
industry attorney said the guidance did not address many critical questions.
FDA earlier this month released the guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements,” removed several sections to streamline the document to focus on core issues, and added examples to
illustrate the definitions in the document, according to a client alert from the law firm King & Spalding.
The firm said one of the largest changes to the document is that FDA backtracked on a recommendation to report to
the agency when device companies enhance a device to reduce a risk to health. Under the statute, companies must report
certain actions concerning device corrections and removals, but not enhancements.
The addition of reporting requirements for improvements in the draft guidance drew criticism because it extended reporting
requirements beyond statutory requirements, Jeffrey Shapiro an attorney at Hyman, Phelps and McNamara said in a blog post.
“[A] device modification that is not a recall is also by definition not a correction or removal... Tellingly, the draft
guidance does not cite any legal authority for this new reporting requirement,” says Shapiro.
Another change to the final document was the addition of examples to illustrate the agency’s definitions for terms
such as recall, device enhancement and stock recovery.
“I think that the agency was very thoughtful...Their overall approach was consistent with the statute,” said Ralph
Hall, counsel at Faegre Baker Daniels. He said the guidance won’t slow down product improvement and provides clarity
to industry stakeholders so there is not a disincentive to innovation.
Hall praised the additions, saying that the examples added to the substantial overall improvement of the guidance in
terms of laying out how FDA is approaching this issue.
But Shapiro said some of the examples added were vague and did not answer important questions. He pointed to
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FDA Week - www.InsideHealthPolicy.com - October 24, 2014
examples added to portray the agency’s definition of device enhancement, but said it did not clarify if the change only
applies to future devices, or whether it applies to products already on the market.
The agency defines device enhancement as a change to improve the performance or quality of a device that is not a
change to remedy a regulatory violation. This includes changes designed to better meet the needs of the user, make the
device easier to manufacture, or improve a non-violative device’s safety or performance.
One of the examples involved a test to detect the level of a specific antigen in blood with 95 percent sensitivity. Two
years later, the firm modifies the product to improve the sensitivity to the antigen from 95 percent to 98 percent.
“This modification is determined to be an improvement to the safety and effectiveness of the device, and is determined to be unrelated to any known device violation,” the agency says. “FDA would generally regard this action as a
device enhancement, although it may require a regulatory submission.” — Erin Durkin
Teva To Submit Third Abuse-Deterrent Hydrocodone NDA By End Of 2014
Teva Pharmaceuticals this month initiated a rolling New Drug Application submission to FDA for an abuse-deterrent
pure hydrocodone tablet, making it the third company in the race to bring such a product to market. Richard Malamut,
vice president of global clinical development at Teva, told FDA Week that the drug was developed according FDA draft
guidance on abuse-deterrent formulations.
Malamut said Teva completed studies in all of the categories FDA recommends in the draft guidance, as well as the
human liability studies.
FDA guidance outlines three categories of premarket studies to assess an opioid’s abuse deterrence. It recommends
companies perform lab studies to test the formulations against methods used by drug abusers to manipulate the product or
alter the amount of drug released. FDA also suggests pharmocokinetic studies to see if certain foods or alcohols increase
the effects of the drug and clinical trials to determine abuse potential.
Teva is expected to complete the submission for its extended-release tablet CEP-33237 with potential oral and
intranasal abuse-deterrent properties by the end of 2014. A nasal human abuse liability study used to support the submission yielded positive results and found abuse potential for crushed intranasal use of the drug to be lower in non-dependent, recreational opioid users, the company said.
Purdue Pharma and Zogenix Inc. also have submitted applications for abuse-deterrent hydrocodone drugs. And FDA
this week approved labeling for a third abuse-deterrent, extended-release opioid (see related story). The agency is slated
to hold a public meeting on abuse deterrence next week. — Stephanie Beasley
Revamped Pfizer Drug Becomes Third FDA-Approved Abuse-Deterrent Opioid
FDA Oct. 17 approved labeling for a third abuse-deterrent, extended-release opioid consistent with guidance on
abuse-deterrent opioids evaluation and labeling. Pfizer’s Embeda, first approved in 2009, will now have labeling with
information about the product’s oral and nasal abuse-deterrent properties, FDA said.
Embeda, a morphine sulfate and naltrexone hydrochloride tablet, releases only morphine when taken properly. When
crushed, the naltrexone blocks some of the euphoric effects of the morphine and can cause withdrawal in people dependent on or tolerant of opioids. FDA said the drug reduces but does not totally prevent abuse by crushing, snorting or oral
ingestion. It should also not be used for “as-needed pain relief” and should only be prescribed to people for whom there
are no appropriate alternative treatment options, the agency said.
Embeda had been evaluated in a clinical trial of 547 osteoarthritis patients when it was first approved in 2009. Pfizer
voluntarily withdrew Embeda in 2011 in response to concerns about the stability of its manufacturing process. FDA
declared that the problems had been resolved with its approval of a manufacturing supplement in 2013.
Pfizer has since conducted additional abuse liability studies in labs and in people to demonstrate the effectiveness of
the drug’s abuse deterrent properties. Studies for intravenous abuse potential showed Embeda was less likely to produce a
high when compared to morphine alone. Still, FDA said it is unknown whether the results from simulated crushed
Embeda could be used to predict a reduction in intravenous abuse.
FDA is requiring postmarket studies of the drug to assess the effects of the abuse-deterrent features. Pfizer is
also required to follow the Risk Evaluation and Mitigation Strategy for extended-release/long-acting opioids that requires
the company to provide educational programs on safe prescribing practices as well as medication guides and patient
counseling documents on use, storage and disposal of opioids.
“The science behind developing prescription opioids with abuse-deterrent properties is still evolving and these
properties will not completely fix the problem,” said Sharon Hertz, acting director of the Division of Anesthesia, Analgesia, and Addiction Products in FDA’s drug center. “But they can be part of a comprehensive approach to combat the very
serious problem of prescription drug abuse in the U.S.”
FDA published guidance on abuse-deterrent innovator drugs in 2013, but has yet to issue guidance on the development of
abuse-deterrent generics. The agency is expected to discuss the issue at a public meeting next week. — Stephanie Beasley
FDA Week - www.InsideHealthPolicy.com - October 24, 2014
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EGA Pushes BQ Alternatives . . . begins on page one
EGA was among the stakeholders that met with WHO last week to discuss the BQ plan that was unveiled in July.
WHO proposed to attach a four-letter code to International Nonproprietary Names, but EGA said different BQ options
should be generated, discussed and studied by an independent organization prior to any action being taken.
“In the absence of such a study, a new system of identifiers cannot be supported and should not be made available
and implemented,” according to EGA’s position on BQs.
Joerg Windisch, chief science officer at Sandoz Biopharmaceuticals and chair of the EGA-European Biosimilars
Group, made EGA’s case during the WHO’s 59th INN consultation last week. Sandoz submitted the first public biosimilar
application that is under review by FDA.
Windisch said the identifiers would be difficult to remember and could confuse patients and providers, according to
EGA’s account of the meeting.
The issue of whether to name biosimilars differently than their originator products has been one of the most controversial issues surrounding FDA’s implementation of the health law’s biosimilar pathway. WHO’s plan has fueled the
debate, but FDA has remained mum on the topic.
European regulators have been reluctant to back the plan’s use within their jurisdiction and biosimilar manufacturers
on the market in Europe agree. They believe that requiring brand-name prescribing, which is the practice in the European
Union, but not the United States, negates the need for an additional distinguishing factor.
EGA points out that a new identifier in the European Union would require a legislative change. “No additional
component is needed in most jurisdictions as they manage very well with the brand name or INN accompanied company
name; the BQ should NOT be implemented in these countries, including the EU since identification of biologicals is
ensured and a number of legal tools and measures are in place,” according to its position.
EGA, like many other stakeholders, said it supports that the proposed BQ system would be voluntary, and apply to
all biologics and retroactively. The group also said it appreciated WHO’s attempt to prevent the proliferation of different
naming schemes.
Innovators support WHO’s approach and want to ensure biosimilars and biologics can be accurately identified via a
distinguishable naming component. But various stakeholders oppose linking the biological qualifier to manufacturing
sites as WHO proposed. There also are different views about how BQs should be used in practice, particularly whether
they should be used for prescribing. — Alaina Busch McBournie
Michigan Becomes Fourth State To Enact ‘Right To Try’ Law
Michigan last Friday (Oct. 17) became the fourth state to enact a “Right To Try” law allowing patients access to
experimental treatments without FDA approval, according to the Goldwater Institute, a group backing state-level action
on the issue. The new law comes on the heels of similar laws in Colorado, Louisiana and Missouri.
The new Michigan law allows patients suffering from advanced illnesses to receive experimental treatments if other
therapies have failed, and such treatment would only be allowed under a doctor’s supervision. Medical professionals and
health care facilities are protected from liability if there are negative drug outcomes.
“Allowing Michiganders dealing with extremely difficult medical situations to try alternative treatment options could
extend or save their lives,” said Michigan Gov. Rick Snyder (R), who signed the state’s “Right To Try” bill into law last
week.
The law follows a recent push from the Goldwater Institute for FDA to treat all experimental drugs the way the
agency has been treating experimental Ebola drugs. “Terminally ill people don’t have time to wait for new drugs to make
their way through the decade-long approval process,” said Darcy Olsen, president of the Goldwater Institute. “Right To
Try lets patients work directly with their doctors to access promising investigational medicines now.” — Erin Durkin
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FDA Week - www.InsideHealthPolicy.com - October 24, 2014
In TPP, Pharma Seeks Time-Based Transitions; Hints At Biologics Flexibility
CANBERRA — U.S. brand-name drug companies are taking the position that they will only support a Trans-Pacific
Partnership (TPP) agreement that includes a time-based transition period for implementing intellectual property (IP)
obligations rather than one linked to development indicators, but are willing to be flexible on their demand for 12 years of
data exclusivity for biologic drugs, according to industry sources.
In exchanges with government officials here and elsewhere, brand-name industry representatives are driving home
the point that a reasonable time-based transition period is an essential part of the IP package in TPP, sources said. Pfizer
Chief Executive Officer Ian Read delivered this message in a letter to senior Australian officials ahead of the Oct. 25-27
ministerial meeting in Sydney, according to one industry source.
Another source said that securing a time-based transition period is the most “pressing” issue for brand-name drug companies, even eclipsing the industry’s demand on biologics data protection. Representatives of brand-name pharmaceutical
companies plan to deliver this message in meetings with TPP negotiators here in Australia, according to this source.
But another source indicated that the industry considers the two issues somewhat linked. This source noted that the
U.S. is the only TPP country pushing for 12 years of data exclusivity for biologics and that therefore a more likely
outcome is for countries to settle on the eight years being proposed by Japan. If the final TPP deal requires only eight
years, then securing a time-based transition period for IP rules becomes even more important, this source argued.
Drug companies are saying they favor a time-based transition period because the alternative option — linking the
standard of IP protection a country must provide to its level of development — sends the wrong message that strong IP
protection is not appropriate for developing countries and is a luxury for rich nations.
Brand-name drug companies have also argued that the time-based transition period provides them with more certainty than a mechanism linked to development indicators, as it essentially establishes a specific date on which the IP
obligations will go into effect.
One industry source argued that CEOs from the brand-name drug industry as well as other U.S. companies are
starting to pay more attention to the TPP negotiations because the Sydney ministerial is being viewed by some as a key
milestone toward concluding an agreement. He said it is the nature of trade negotiations that CEOs start getting involved
when the talks are closer to the end.
The debate over the transition mechanism for pharmaceutical IP obligations is one of the most contentious
outstanding issues in the TPP negotiations. It arose after TPP negotiators coalesced around a U.S. proposal that would
allow less-developed members to temporarily provide a lower standard of drug IP protection than more developed
members.
Under the U.S. proposal, the lower standard would be in line with IP obligations included in the May 10, 2007, deal
between the Bush administration and House Democrats, which changed provisions of three pending free-trade agreements
on issues related to IP, labor and environment. Among other things, the May 10 deal made patent linkage and patent term
extension optional for developing countries. But it made these flexibilities permanent, while the U.S. approach in TPP
would eventually require developing countries to give them up.
The higher standard under the U.S. TPP proposal more closely resembles U.S. FTAs with Australia, Singapore and
Chile, which made patent linkage and patent term extensions mandatory, among other things.
Access to medicines advocates and many congressional Democrats prefer a transition mechanism based on development indicators, in part because they view that approach as reflecting the May 10 deal. This is because it would preserve
the notion that a lower level of pharmaceutical IP protection is applied to developing economies while a higher one is
applied to developed countries.
Despite endorsing the transition mechanism tied to development indicators, many advocates for access to medicines
like consumer advocacy group Public Citizen still firmly oppose the idea of including IP obligations in TPP that go
beyond World Trade Organization rules.
The U.S. had initially proposed a transition mechanism in TPP linked to development indicators, which would
graduate developing country members to the more stringent IP standard when they qualify as high-income countries for
two consecutive years. This would have been based on the definition used by the World Bank, which groups countries
into income categories based on their gross national income per capita. That approach is laid out in a non-paper included
as Addendum 1 to a purported TPP IP text leaked last week.
But an alternative approach employing time-based transition periods is described in another non-paper attached to
the text as Addendum 2. This non-paper, which does not identify the country putting it forward, proposes that the most
developed TPP countries be given two years to comply with their obligations on pharmaceutical IP. Middle-income TPP
countries including Mexico and Brunei would be given a slightly longer transition period, while Peru and Vietnam would
get an even longer time to comply. The lengths of these two latter transition periods are not specified in the non-paper.
An industry source stressed that brand-name drug companies are willing to provide countries like Vietnam and
Malaysia reasonable time periods to implement the higher IP standard because doing so will require legal reforms and
possibly technical assistance. This source declined to identify what these companies consider a “reasonable” time period,
FDA Week - www.InsideHealthPolicy.com - October 24, 2014
5
but noted that previous U.S. FTAs have included transition windows of between three and five years.
TPP countries have also been considering three other mechanisms for transitioning between the two pharmaceutical
IP standards, according to the undated paper obtained by Inside U.S. Trade in July. One of those options would allow
TPP countries initially adhering to the lower standard to “self-select” the criteria for graduation to the higher standard.
In a memo analyzing the leaked text, Public Citizen argued that a transition mechanism based on development
indicators is preferable because it would ensure that countries would not have to bear the brunt of higher medicine prices
until they were sufficiently developed economically to absorb those associated costs.
By contrast, a time-based transition period would require those countries to pay more for medicines even if they
could not absorb those costs. The group speculated that the longest transition period the U.S. would accept for developing
countries is 10 years.
“Addendum II proponents argue that it would provide greater certainty to brand name pharmaceutical companies, but
it would require even the lowest resource countries to adopt stringent policies that would extend patent monopolies and
limit access to medicines within 10 years of the TPP entering into force … , regardless of a country’s ability to absorb the
associated costs,” Public Citizen said.
“Alternatively, Addendum I at least would assure countries that they need not adopt certain policies unless their
economy was relatively better placed to handle this additional strain — even if took longer than 10 years to reach such a
level of economic development,” it added. — Inside U.S. Trade
Ebola Outcomes Considered . . . begins on page one
break for cues on how to spur orphan drug development. An industry official praised FDA for its fast action and said once
the outbreak has been diminished the agency should examine how authorities used to expedite access to Ebola treatments
could be applied to other rare diseases.
The Ebola crisis highlights the opportunities for FDA and other agencies to “raise the bar” for advancing treatments
for rare diseases, Robert Hugin, chairman and CEO of Celgene said during a National Organization for Rare Disorders
event Wednesday (Oct. 22).
Hugin said it’s important that public health institutions are rallied to do all of the things that they have been doing to
address Ebola. When they “trumpet” their Ebola efforts it highlights the opportunities for rare diseases, he said.
“[W]hat strikes me about it when people trumpet and they talk about the great things we’re doing for Ebola,
it highlights to me the opportunity for us,” Hugin said. “Why wouldn’t we take the same extraordinary measures to
challenge clinical trials strategies, to challenge regulatory requirements, testing requirements for drugs for people that are
so, so under-served.”
In August, FDA authorized emergency access to the experimental Ebola treatment ZMapp and classified it as an
orphan drug. The Goldwater Institute, which has backed “Right to Try” state laws providing patients with early access to
experimental drugs, also has suggested FDA authorize use of experimental treatments for life-threatening diseases and
conditions more broadly (see FDA Week, Oct. 10).
But Amy McKee, clinical team leader at the Office of Hematology and Oncology Products in FDA’s drug center, said
ZMapp maker Mapp Biopharmaceuticals exhausted their clinical trial supply by providing early access to the drug. Some
companies are not financially able to make such a move, she added.
Kay Holcombe, senior vice president of science policy at the Biotechnology Industry Organization, further noted that
many companies would prefer not to forgo FDA review of their products and suggested rare disease patients seek
guidance from patient advocacy groups that often have information about other options besides emergency authorized
access to an unapproved drug.
She added that some companies remain skeptical of the expanded access program and have concerns that include
whether providing early access could adversely affect approval of the drug. Holcombe highlighted that there is uncertainty about how an adverse event associated with a patient given access to an experimental drug, but who would not
qualify for a sponsor’s clinical trial, might affect the overall development program and FDA review.
“It may not be that we need to change the behavior at the FDA, but we need to change the understanding of how FDA
is going to behave,” she said.
Pharmaceutical Research and Manufacturers of America also has called on FDA to provide clear and detailed
guidance to companies about how safety and efficacy data from expanded access patients will be used if the agency wants
to optimize use of the program.
During the NORD event, Hamburg listed recent FDA actions to address the ongoing Ebola outbreak, saying
the agency is responding as flexibly as it can to enable access to new treatments and develop clinical trial protocols to test
their safety and effectiveness. Earlier this month, FDA granted emergency use authorizations to two diagnostics developed by the Centers for Disease Control and Prevention to detect the Ebola virus and issued an EUA for a U.S. Department of Defense-supported diagnostic in August.
Hamburg said, however, that it is less likely that any of the three Ebola vaccines in development would receive
6
FDA Week - www.InsideHealthPolicy.com - October 24, 2014
orphan drug status, unlike some investigational Ebola treatments.
“We’ve been asked about whether we can do that in the vaccine area as well but while other treatments might qualify
for orphan status it’s unlikely that a vaccine would because it is intended to be protective and therefore be given to a
much broader swath of the population,” Hamburg said.
The National Institutes of Health said this week that it began human testing for a second investigational Ebola
vaccine. Further, the Biomedical Advanced Research and Development Authority recently contracted with Profectus
Biosciences Inc. to develop a third Ebola vaccine. — Stephanie Beasley
E&C Republicans Highlight Ebola Dx Shortfalls In Travel Restrictions Push
House Republicans Thursday (Oct. 23) requested details from the Obama administration about its efforts to stop the
Ebola outbreak from spreading to the United States, with the lawmakers highlighting the need for rapid point-of-care
diagnostics. The letter follows an Energy and Commerce hearing where lawmakers told top public health officials that
they would “hold their feet to the fire” regarding the government’s Ebola response.
The group of 28 lawmakers that includes House Energy and Commerce Chairman Fred Upton (MI) and oversight and investigations panel Chairman Tim Murphy (PA) pressed for travel restrictions on passengers from West
Africa. In the letter they ask for more information about the administration’s plan to prevent the spread of Ebola in
the United States, rationale behind its opposition to travel restrictions, efforts to improve the development of
diagnostic testing and screening, and the capacity of the domestic public health system to identify and treat patients
with Ebola.
FDA has granted emergency use authorization for three diagnostics devices — two from the Centers for Disease
Control and Prevention and another from the U.S. Department of Defense. But the committee said the administration
should improve the availability of point-of-care diagnostics and seeks details on the status of all rapid diagnostic tests that
could be developed and deployed in West Africa and to screen travelers to the United States.
“Without such a test, we continue to believe the administration should evaluate options to limit these flights while
ensuring the area is still able to receive the personnel and supplies necessary,” the committee members write.
The lawmakers further push for information about how the White House is coordinating efforts within the executive
branch related to the development of diagnostic testing, the process that is or will be used to assess the information
gathered, and what process will be used to expedite deployment of rapid diagnostic testing.
The lawmakers ask for a White House analysis or modeling to support the claim made by public health experts from
the CDC and other agencies that restricting travel of foreign nationals from Ebola-affected countries would decrease
tracking abilities and increase the risk of importing Ebola cases into the United States.
Additionally, the lawmakers seek information about the number of Ebola cases expected to be imported to the United
States over the next six months, how the White House is coordinating the collection of such information, the capacity of
the public health system to handle Ebola cases, and the capacity of federal agencies and contractors to provide transport
for medical and military personnel.
“Energy and Commerce Committee members have serious concerns about insufficient planning and preparedness
from the administration in response to the ongoing Ebola threat,” Upton said in a statement. “In an effort to provide some
peace of mind to the American people, we continue to ask the administration to outline a clear strategy and work with us
to ensure that every step necessary is being taken to protect the public health. With a disease as deadly as Ebola, there is
no margin for error.” — Stephanie Beasley
NIH Starts Human Trials On Second Ebola Vaccine Candidate
Researchers at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases are conducting
a phase 1 clinical trial in Bethesda, MD to test the safety and immunogenicity of Ebola vaccine candidate VSV-ZEBOV,
NIH said Wednesday (Oct. 22). The Public Health Agency of Canada developed the vaccine and it is licensed to
NewLink Genetics Corp.
The structure of the multi-site trial will allow a real-time evaluation of the safety profile at different dosing levels,
NIH said.
The NIH trial will enroll 39 adults who will be assigned to three groups of 13 participants. Within those groups, 10
participants will receive the investigational vaccine and three will receive a placebo. Each group will receive a different,
escalating dose of the vaccine, NIH said. Participants will receive two intramuscular doses, known as prime-boost
strategy, with one occurring 28 days after the first. There will be interim safety assessments of vaccinated participants
before moving onto the next dosing level, NIH said.
The vaccine will also be tested at the Walter Reed Army Institute of Research in Silver Spring, MD as a single dose
injection.
“This is being done to evaluate in real time the safety profile of the investigational vaccine when provided at differFDA Week - www.InsideHealthPolicy.com - October 24, 2014
7
ent dosages and compare the immune responses induced by one injection versus two injections,” NIH said. “Initial safety
and immune response data on the VSV-ZEBOV vaccine are expected by the end of 2014.”
NIAID is also testing a different Ebola vaccine candidate co-developed with GlaxoSmithKline and results from that
trial are expected by the end of the year, NIH said. — Alaina Busch McBournie
Drug Exclusivity Debated . . . begins on page one
Exclusivity and other market incentives are a small piece of what stakeholders have offered up as ideas for the
committee, which is looking at increasing clinical trial efficiency, streamlining National Institutes of Health grants and
centralizing Institutional Review Board reviews, among other topics. Pitts told a biologics industry audience last week
that incentives, such as exclusivity, could be part of the reform effort. The committee plans to produce a discussion draft
of legislation in January.
Innovator drug companies and some patient groups, in submissions to the committee since the initiative launched,
outline several ideas targeting exclusivity.
Many drug companies ask the committee to reconsider existing exclusivity for small molecule drugs. One
lobbyist suggested that companies are proposing exclusivity extensions because this reform initiative is not tied to
PDUFA, therefore there is not concern about possibly delaying passage of industry’s user fee program with other requests. Some of the more general requests for exclusivity could be costly and problematic, but narrowly tailored proposals could have a better chance of being considered, the source said.
New drugs currently receive five years of exclusivity, but incentives exist to extend this market protection. The FDA
Safety and Innovation Act, for example, included five years of additional exclusivity for qualifying antibiotics.
In response to the committee’s call for action, the National Venture Capital Association suggests extending data
exclusivity in areas of unmet need. The American Psychiatric Association asks that the committee consider market
exclusivity for novel first-in-class drugs, patent extensions and data protection. The Parkinson’s Action Network asks
lawmakers to analyze the need for additional incentives, such as tax laws, patent system reforms and exclusivity provisions to spur treatments for diseases like Parkinson’s and Alzheimer’s.
“If there is good science to pursue on Parkinson’s, we want to ensure it is still not benched because of greater cost
and less likelihood of success,” PAN said.
In asking for more exclusivity for small molecule drugs, some companies assert that the market has evolved
since the Hatch-Waxman Act established the generic drug structure.
“Industry dynamics including, but not limited to, the availability of venture and other forms of private capital, a gap
in highly skilled workers, and biopharmaceutical competition have evolved considerably since Congress passed the
Hatch-Waxman Act in 1984,” says Pharmaceutical Research and Manufacturers of America. “As a result, there have been
dramatic increases in rates of generic penetration and patent litigation, declines in the availability of venture capital, and
challenges in finding workers with the (science, technology, engineering and mathematics) skills needed.”
As a result, PhRMA suggests that the current five years of data protection for small molecule drugs “may be insufficient.” Other individual companies echo this thought. PhRMA also asks that Congress preserve the 12 years of exclusivity
granted to biologics under the health reform law that created the biosimilar pathway.
The Biotechnology Industry Organization suggests lawmakers focus on serious diseases, like Alzheimer’s.
“BIO encourages the Committee to look at various approaches to intellectual property incentives, including through
refining both patent and data protection, to determine if the current structure continues to promote innovation in the best
way possible,” according to BIO’s submission. “Consideration also could be given to the establishment of incentives for
the development of interventions for serious diseases that pose significant public health issues, such as Alzheimer’s
disease and multi-drug resistant organisms. These incentives could take the form of regulatory exclusivity, patent
protection, or other approaches.”
The committee’s discussion draft could include both ideas from previously introduced legislation and new concepts.
On the exclusivity front, the Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network (MODDERN)
Cures Act has generated some debate, including some opposition. The bill would provide 15 years exclusivity to dormant
therapies that address unmet medical needs.
During a National Organization for Rare Disorders event this week, Rep. Henry Waxman (CA), the top
Democrat on Energy and Commerce, took aim at the bill as part of 21st Century Cures talks. He said it falls short
of the goal of providing faster access to cures without undermining FDA’s approval standards.
“Virtually any drug with a novel active ingredient could qualify for this reward,” he said. “Well, that’s giving away too
much. That’s going to upset the ability of making drugs affordable and is far more of an incentive than I think is justified.”
Waxman said Congress should instead work to ensure proposed legislation is tailored to address a clearly identified
problem. He added that priority also should be given to increasing NIH’s budget, which is also a priority for drug
companies and other stakeholders. Before launching new initiatives, it is critical that NIH’s resources be restored so that
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FDA Week - www.InsideHealthPolicy.com - October 24, 2014
it can advance biomedical research, Waxman said.
AARP also recommends that lawmakers proceed with caution in expanding incentives, saying any expansion
of market exclusivity should be done in limited circumstances.
“There is also no evidence that increasing market exclusivity would result in an increase in innovation,” AARP tells
lawmakers. “In fact, there are indications that current incentives may instead favor market potential and profit: many of
the drugs approved in the past decade are mostly minor variations on existing drugs, and most new drugs are not superior
on clinical measures. Consequently, any efforts to build on these existing incentives should be undertaken with an
overabundance of caution to ensure that they have the intended effect.”
The Generic Pharmaceutical Association also urges caution when evaluating proposals to extend exclusivity, saying
“excessive” periods of exclusivity could discourage innovation due to a lack of competition. GPhA says lawmakers
should take a more holistic approach to determine why drug development is lagging in certain areas.
“Pinpointing the reasons for lack of investment can help isolate the appropriate incentive,” the lobby group says.
“GPhA and its members understand that the generic and biosimilar industry is dependent upon the development of new
therapies, which is why a measured approach should be taken to determine the appropriate incentives to spur
innovation.” — Alaina Busch McBournie and Stephanie Beasley
Industry Report: GPOs Follow Ethical, Transparent Practices, Can Self-Regulate
The Healthcare Group Purchasing Industry Initiative (HGPII) in a new report asserts that group purchasing organizations use ethical business standards that show the industry can self-regulate. The Oct. 20 report comes in advance of a
Government Accountability Office report, expected in November, that will examine whether GPO contracting practices
led to generic drug shortages that forced hospitals to turn to compounding pharmacies.
The report, written by law firm Arent Fox for HGPII, is the ninth in a series of annual reports that show HGPII
participants adhere to a set of six principles that ensure ethical and transparent business practices for GPOs that are
designed to provide quality healthcare products for hospitals while reducing costs. Report authors, former Rep. Philip
English (R-PA) and former Sens. Byron Dorgan (D-ND) and Robert Bennett (R-UT), say the firm only produces the
yearly ethics report for HGPII and does not lobby for the trade group.
“This demonstrates that self-regulation can be and is effective,” Dorgan said during a web briefing on the report.
“Our evaluation of that effectiveness each year is a demonstration that this works.”
English said the report confirms that the 11 GPOs that participate in HGPII adhere to the initiative’s six core principles;
scrupulously avoid conflicts of interests among their employees; keep administrative fees to 3 percent; use transparent bidding
and awards processes; keep contract terms to between two and three years; limit “sole source” contracts; only bundle contracts
for related items; promote innovative products; have internal grievance policies that protect whistle blowers; have active and
accessible grievance processes for vendors; regularly conduct ethics and best practices training for employees; participate in
yearly HGPII best practices training; and promote diversity among vendors they contract with.
The 11 GPOs that participate in HGPII include Amerinet Inc., Children’s Hospital Association, GNYHA Ventures Inc.,
HealthTrust Purchasing Group, HPS, Innovatix LLC, MedAssests Inc., Novation LLC, Premier Inc., Texas Purchasing Coalition and Yankee Alliance. As part of their participation, the HGPII-aligned GPOs take part in the yearly report by submitting
answers to a 100-question public accountability questionnaire; participate in follow-up interviews based on their answers to the
questionnaire; undergo randomly selected site visits; and participate in the annual HGPII Best Practices Forum.
“I believe the healthcare supply chain is currently more transparent, more accountable and more wedded to a culture
of best practices and business ethics than at any time in history,” English said based on the report. “GPOs are continuing
to apply new supply chain innovations to healthcare, while expanding their product and service offerings to members.”
The report stated the 96 to 98 percent of hospital supply purchases are made through GPOs, and English pointed out
the two of the industries largest firms are part of HGPII.
Lee Perlman of GNYHA Ventures and chair of the HIGPII board said member GPOs take the process to implement
ethical and transparent business practices very seriously.
“We’re very, very proud to be the most transparent part of the healthcare supply chain ecosystem” Perlman said. “I
think what we created now almost a decade ago is a standard as Congressman English indicated for what is self-regulation
and transparency. We believe we do a terrific job everyday.”
English said the report will be presented to Congress in December.
Before that, however, it is expected that the GAO will release its report on the contracting practices of GPOs with
compound pharmacies.
The GAO report is a response to November 2012 letters from Democratic lawmakers Reps. Ed Markey (MA), Henry
Waxman (CA), John Dingell (MI), Frank Pallone (NJ), Diana DeGette (CO), and Anna Eshoo (CA) seeking to determine
whether GPO contracting practices led to generic drug shortages that forced hospitals to use compounding pharmacies to
fill drug shortages. The letters came out of a House investigation of a 2012 fungal meningitis outbreak linked to a
compounding pharmacy that left 12 people dead. — Todd Allen Wilson
FDA Week - www.InsideHealthPolicy.com - October 24, 2014
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FDA To Finalize GRAS Rule . . . begins on page one
CFS entered a settlement with FDA Monday (Oct. 20) requiring the agency to finalize the GRAS rule by August
2016, echoing what the agency said in a May court brief. The group’s lawsuit originally requested that FDA vacate the
rule and revert to its previous GRAS affirmation petition process.
If the final rule looks similar to its 1997 proposed form, CFS would consider a legal challenge to ensure the agency
makes some improvements, said Donna Solen, senior attorney at the Center for Food Safety. For example, Solen said
CFS wants the GRAS review process to be more transparent by allowing more information about GRAS determinations
be released to FDA and the public.
Solen said because the rule was only in proposed form, the group could not challenge it in court.
Thomas Neltner, an attorney and public critic of the GRAS program, said finalizing the rule will allow the agency to
clear up any ambiguities about the rule and fix flaws within the proposal.
“I think the agency has come a long way from 1997...the discussion has advanced in many ways,” Neltner said.
Neltner said a 2010 Government Accountability Office report lays out key issues that the agency should address
before the rule is finalized, such as conflicts of interest in GRAS reviews. Otherwise the agency risks a lawsuit, he said.
He pointed to the fact that the GAO report recommended the agency develop a strategy to minimize the chance for
conflicts of interests in companies’ GRAS determinations, including issuing guidance for companies and requiring
information in GRAS notices regarding expert panelists’ independence.
GAO also recommended that the FDA require any company that conducts a GRAS determination to provide FDA
with “basic information — as defined by the agency to allow for adequate oversight — about this determination, such as
the substance’s identity and intended uses, and to incorporate such information into relevant agency databases and its
public Web site.”
The settlement comes on the heels of an industry-generated initiative aimed at revamping safety assessment of food
ingredients by defining standards for ingredient safety assessments and ensuring FDA has more information about GRAS
determinations through a database.
The plan, which was unveiled by the Grocery Manufacturers Association in August, was a step forward with GAO’s
recommendations, but the agency should go further, Neltner said.
The Center for Food Safety brought a lawsuit against FDA in the U.S. District Court for the District of Columbia in February, asserting that FDA violated the Administrative Procedures Act. CFS argued that FDA implemented
the GRAS review system without going through the mandatory notice-and-comment period because it did not
finalize the 1997 rule. — Erin Durkin
PCORI Participants Struggle To Avoid Discussing Cost In Hep C Rx Debate
Participants at PCORI’s recent meeting on hepatitis C treatments struggled to avoid talking about cost because they
said they wouldn’t be holding a meeting on the treatments were they not so expensive. The ACA-created Patient-Centered
Outcomes Research Institute by law is not allowed to fund research on economic outcomes, but the institute put out an
updated guidance last month saying it would consider research on how patients’ out-of-pocket costs affect access to care.
PCORI met Oct. 17 to gather input from the public on comparative-effectiveness research on hepatitis C drugs.
Participants discussed research that compares new hepatitis C drugs in real-world settings and research that evaluates
when to treat patients and how to diagnose and manage them. Those categories go straight to the heart of restrictions that
many state Medicaid programs are imposing on Gilead’s expensive new hepatitis C drugs. (The recently approved
Harvoni costs $94,500 for a 12-week course.) States often require that patients be in the later stages of the infection
before receiving the drugs; often don’t cover the drugs for residents addicted to alcohol and street drugs; and sometimes
only allow specialists to prescribe the drugs, even though there are too few specialists to treat all the hepatitis C patients.
Much of the debate at the meeting was over whether research is needed at all. Some participants, especially
patient advocates, questioned the wisdom of spending limited PCORI funding for comparative-effectiveness studies on
drugs that cure nearly everyone with few side effects. Also, some noted that drug companies, including Merck and
AbbVie, are developing promising hepatitis C drugs and their research might answer many of the questions that participants raised, such as reinfection rates among drug addicts and alcoholics.
But PCORI methodology committee member Naomi Aronson said the scientific rationale that state Medicaid
programs are giving for prescribing restrictions “is not sound.” Like it or not, the reality is that states are restricting
coverage of hepatitis C drugs because they can’t afford to cover them without taking money from other programs, she
said. Given that reality, comparative-effectiveness research could be used to determine the harm in not treating people
who are in earlier stages of the disease.
Also, patients must cover up to 20 percent of drug costs so patients also likely want to know the consequences
of delaying treatment, Aronson said.
“One of the things that could be valuable to know is, under circumstances where there are limited resources and there
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FDA Week - www.InsideHealthPolicy.com - October 24, 2014
needs to be some kind of prioritization of treatment, ‘What is the most beneficial, what is the least risky?” she said.
“The reality of the financial situation at the state level is true and I hope that we can get the best evidence possible to
help make the best decision,” she added.
Lorren Sandt, executive director of Caring Ambassadors Program, said state Medicaid officials don’t believe
data from drug companies on hepatitis C drugs. PCORI must decide to either send a strong message that the current
research data suffices or fund research solely to make it more difficult for Medicaid programs to restrict access.
“I agree with you that your clinical trial data is solid,” she said, referring to drug companies. “I agree with you 100
percent. I think it’s wrong that they are ignoring it. But the arguments that we’re having in front of Medicaid programs is
that they say there’s no data to prove these drugs work. So we need to address that. We need to come together as a group
and say, ‘You’re wrong. They do work.’ ... Or we have to fund it and get these patients care. ” — John Wilkerson
Industry, Gov’t Officials: Healthcare Should Emulate Others On Cybersecurity
The healthcare sector should emulate other critical infrastructure sectors on cybersecurity, but should also nail down
unique aspects to healthcare and medical device cybersecurity, government and industry officials said during a Wednesday (Oct. 22) event hosted by FDA.
Bakul Patel, associate director for digital health at FDA’s Center for Devices and Radiological Health, said the
industry will have to take broad cybersecurity standards and make them meaningful to medical devices and healthcare
facilities.
Kevin Stine, from the National Institute of Standards and Technology, said during an event on medical device and
healthcare cybersecurity that NIST’s cybersecurity framework demonstrates significant commonalities among sectors. He
noted there are differences among sectors, but that the framework provides a common lens through which industries can
view cybersecurity.
Kevin Hemsley, with the Department of Homeland Security’s Industrial Control Systems Cyber Emergency
Response Team, said there are similarities between cyber issues in ICS and in medical device and healthcare
cybersecurity. He said the ICS realm has found that a “common document” that provides cybersecurity specifics
tailored to the industry has been useful in dealing with cyber issues, and encouraged the healthcare sector to follow
a similar strategy.
Brian Peretti, director of the Treasury Department’s Office of Critical Infrastructure Protection and Compliance
Policy, drew another parallel to the healthcare sector, stating that it, like the financial sector, has to deal with vendors
providing cyber products. “How do they integrate that [into cybersecurity practices]?” Peretti asked.
Mary Logan, president and CEO at the Association for the Advancement of Medical Instrumentation, elaborated on
the unique aspects of cybersecurity in healthcare during her keynote at the Arlington, VA event.
Logan said that healthcare cybersecurity must take into consideration the multiple entities that regulate healthcare.
For example, Logan said the FDA oversees medical device standards while the Federal Communications Commission
holds jurisdiction over wireless technologies. — Joshua Higgins, Inside Cybersecurity
Public Citizen Alleges FDA Is Hiding Opposition To Journal Reprint Guide
Public Citizen thinks FDA is subverting the public feedback process by not posting comments on recent guidance
that proposes to let companies communicate new information about risks and benefits not included on drug labeling. The
group, which opposes the guidance, points out that since the comment period for the document closed in August, FDA has
posted one of the 1,781 comments it received. In a letter sent to HHS Wednesday (Oct. 22) Public Citizen also calls for
the withdrawal of the guidance.
The draft guidance lays out recommended practices for the distribution of reprints or digital copies of articles that
include new risk information for drugs not included in FDA-approved labeling. The comment period closed Aug. 25, and
Public Citizen filed a Freedom of Information Act request Oct. 15 for the full text of all the comments.
“The draft guidance ultimately lets the pharmaceutical industry tell doctors that medications are safer than they really
are. If finalized as written, it will be very dangerous to public health and safety,” said Sidney Wolfe, senior adviser of
Public Citizen’s Health Research Group. “It is likely that a large proportion of the 1,780 undisclosed comments are in
objection to this reckless proposed FDA guidance. By not making these comments public, it looks as if the FDA is trying
to cover up opposition to the inherent dangers of the proposal.”
Public Citizen has been critical of FDA’s proposal, saying the agency is cowing to industry by permitting companies
to under-emphasize the significance of certain risks that appear on FDA-approved labeling. The group sent a letter to
HHS Secretary Sylvia Burwell this week requesting HHS step in and require FDA to withdraw the guidance.
However, key industry groups like the Medical Information Working Group and Pharmaceutical Research and
Manufacturers of America said they believe the FDA guidance sets too high of a bar for disseminating efficacy information and goes against recent court rulings protecting commercial speech. — Stephanie Beasley
FDA Week - www.InsideHealthPolicy.com - October 24, 2014
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As FDA praises manufacturer plan...
Legal Experts Tout Need For More FDA Authority To Respond To Drug Shortages
Legal experts say Congress should give FDA new power to respond to shortages of critical drugs, floating the ideas
of letting FDA temporarily repurpose a drug license to another company, akin to NIH’s march-in rights, and allowing
importation from unregistered foreign manufacturers. The suggestions came a week after pharmaceutical engineers
released a manufacturer-spearheaded drug shortage prevention plan that drew some praise from FDA and European
regulatory officials.
Charleston School of Law Professor William Janssen discussed the repurposing idea at a recent Food and Drug Law
Institute conference, where he said this would be preferable to a judicial decision being made on a manufacturer’s
obligation to produce critically important drugs.
Janssen discussed two cases brought in the last 18 months by seriously ill patients who sought judicial solutions to
“negligently-caused” supply interruptions to critical drugs. He explained that the litigants asserted the courts ought to
impose upon drug manufacturers a legal duty to continue selling their medicines.
The courts have been continually confronted with similar cases that have made a plethora of arguments, said Janssen,
who added that he didn’t think a judicial decision on this issue is the appropriate or best solution.
“I would much rather see a thoughtful legislative or regulatory solution crafted with all of the stakeholders involved
in the discussion,” he said, adding that granting another company a period of exclusivity during a drug shortage period in
order to solve the problem could be an incentive to get suppliers involved.
“The only wrong answer in that equation is the judicial answer,” he added.
A research fellow and lecturer in law at the Seton Hall University School of Law, also presenting at the conference,
likewise said the agency may need further legislative authority to respond to drug shortages.
“I would suggest...further legislative action might be needed,” said Kate Greenwood. “FDA appears to believe it still
needs the ability to allow importation from unregistered foreign manufacturers.”
The question as to whether FDA could import foreign drugs to solve drug shortages was at the heart of the 2013
court case Cook v. FDA, where the U.S. Court of Appeals for the District of Columbia Circuit determined FDA did not
have the authority to remedy a drug shortage of thiopental, a drug used in executions, by importing products from an
unregistered foreign manufacturer.
These ideas were floated a week after the International Society for Pharmaceutical Engineering (ISPE)
unveiled its Drug Shortages Prevention Plan, which garnered praise from FDA and the European Medicines Agency,
according to a blog on the group’s website.
“Congratulations to ISPE,” said Douglas Throckmorton, deputy director for regulatory programs in FDA’s Center for
Drug Evaluation and Research. “Cooperation between industry and regulators is essential to preventing shortages before
they occur, and the plan highlights the value of cooperation for us to continue making progress in preventing drug
shortages.”
The plan builds on results from ISPE’s 2013 Drug Shortages Survey that found that manufacturing quality issues
were a major cause of drug shortages.
ISPE says manufacturers should consider the following strategies to avoid manufacturing disruptions and drug
shortages:
Corporate quality culture, which describes the importance of viewing quality as a necessity rather than a hindrance.
Robust quality system, which highlights the ability of the company’s quality system to integrate Good Manufacturing Practice (GMP) regulations.
Metrics that measure the performance of the quality system and operational elements.
Business continuity planning, which explores how companies have established supply chains that are robust,
redundant where appropriate and resilient to ensure continuity.
Communication with authorities, that looks at what companies can do to improve communication with regulatory
agencies.
Building capability, which summarizes the capability needs required for each of the elements described in the
plan.
“I want to thank the ISPE team for their hard work in response to a challenge [European Medicines Agency] laid
down last year,” said Brendan Cuddy, scientific administrator for EMA. “There are a plethora of reasons behind
drug shortages. The supply chain is complex and we know that at every stage there is an opportunity for a problem
to arise.”— Erin Durkin
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FDA Week - www.InsideHealthPolicy.com - October 24, 2014