FDA is set to
embark on the first big step in using its new healthcare reform-created
biosimilars approval pathway, with the agency planning to hold a two-day public
meeting in early November on biocompatability, patents, user fees,
clarification of certain critical definitions, pharmacovigilance and guidance
development, according to a draft Federal Register notice announcing the
meeting that is circulating among industry.
Key consumer
groups came to opposing conclusions on whether there is a "material difference"
in genetically engineered salmon and whether special labeling should be
required, as FDA weighs approving a GE animal for human consumption for the
first time. Industry stakeholders opposed special mandatory labeling for the GE
salmon, but one of the consumer advocates floated a voluntary labeling scheme.
Consumer
groups continue to question the safety data that FDA is assessing in deciding
whether to approve transgenic salmon, and are highlighting differing viewpoints
discussed by scientists on the issue at a recent veterinary advisory committee
meeting. In light of these data concerns, some consumer advocates called into
question whether FDA should approve the product at all, much less require
special labeling.
Generic drug
manufacturing giant Mylan diverged from plans offered by other industry groups
during inaugural user fee talks by introducing a proposal featuring a
three-pronged approach that a top company official said would prioritize safety
over the speed of application review times.
The General
Accountability Office on Thursday appointed Robert Jesse of the Veteran's
Affairs office as the government representative on the governing board for the
health reform law's independent comparative effectiveness research institute,
upsetting some consumer and personalized medicine advocates who had hoped FDA
would be represented.
The
Department of Justice intervened this week in an off-label and kickbacks qui
tam suit against drug maker Wyeth for illegal marketing of its
immunosuppressant drug Rapamune, with sources suggesting that the agency's
involvement signals the government likely has a strong case. DOJ's involvement
in the case, coupled with a key House lawmaker's investigation of the
allegations, now has all three branches of government involved in the suit.
Sen. Chuck
Grassley, a lead congressional overseer of FDA, will not likely serve as the
top Republican on the Finance Committee during the next Congress and is eyeing
the Judiciary Committee as his next perch, a move that could alter -- but not
diminish -- his interest in healthcare and FDA-related issues, sources said.
The transition could also provide an opening to Senate health committee Chair
Tom Harkin (D-IA), who recently set up a health care investigations unit, to
play a larger role in overseeing federal policies relating to drugs and
devices, sources said.
After months
of debate over the fate of the diabetes drug Avandia, FDA has decided not to
pull the drug off the market and to instead develop a Risk Evaluation and
Mitigation Strategy that includes a registration system expected to severely limit
the number of patients prescribed the drug. The agency has also halted a
controversial study of the drug, a move sought by drug safety advocates, some
of whom had also called for Avandia to be removed from the market. FDA's
handling of Avandia has been viewed by consumer advocates as an indicator of
the Obama FDA's treatment of post-market drug safety issues.
An updated
bill designed to ensure gender-based differences in drugs and devices are
properly documented by sponsors of clinical studies was passed by a House
committee this week, and congressional staff want to see it taken up on the
House floor next week. The bill would require the Government Accountability
Office to report to Congress on existing compliance with regulations requiring
the inclusion of females in clinical trials submitted to FDA. The original
version of the bill would have directly codified those regulations.
Comparative
effectiveness research at FDA is moving forward with recently awarded contracts
to refurbish the agency's legacy data and develop standards, and plans by FDA
to announce by the end of the month a final CER award to develop research
centers, according to sources and agency contracts. Industry sources are
watching with concern FDA's new focus on CER, while a consumer advocate said
the program should be expanded and consider existing studies.
Increased
enforcement including civil and criminal penalties as well as mandatory recall
authority--provisions listed in the pending food safety legislation--would give
FDA "stronger teeth" to pursue food safety violators, a top agency official
said during a congressional hearing on the recent egg recall.
A recent
survey shows FDA scientists are concerned with what they view as political
interference in agency decisions and feel there is a need for strengthened
whistleblower protections, along with a need to pass pending food safety
legislation to address a slew of other issues affecting agency scientists.
Thirty-four percent of those surveyed said they had experienced political
interference in the past year.
As FDA began
preliminary talks on establishing a generic drug user fee, stakeholders
discussed ways to address issues facing the industry, such as "pay for delay"
and insufficient foreign oversight.
The
Democratic leaders of the House Energy and Commerce Committee are circulating
draft language of a long-awaited imported drug safety bill, which would give
FDA a slew of new powers, including mandatory recall authority and the ability
to demand the confiscation and destruction of pharmaceuticals at the border,
while also enabling the agency to collect fees from drug manufacturing
facilities and importers in order to fund the bill's safety programs. The
bill's supporters, including committee chair emeritus John Dingell (D-MI), hope
to pass the bill prior to the 2012 drug user fee reauthorization, sources say.
The chief
Republican opponent to bipartisan food safety legislation in the Senate could
emerge as an ally to a key Democrat in her bid to create a single food safety
agency, sources said. Rep. Rosa DeLauro -- chair of the House FDA
appropriations subcommittee -- has long called for a single food safety agency
to consolidate oversight. An aide to Sen. Tom Coburn (R-OK) said the lawmaker
"would consider consolidation but not a new agency per se" after Coburn gave an
impassioned speech on the Senate floor Wednesday (Sept. 21) on his perceived
faults in the food safety managers' package that does not address this
fragmented oversight.
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