FDA and CMS on Thursday revealed they are considering establishing a process to conduct parallel reviews of medical products, while also establishing a pilot project for these types of product assessments for devices. Industry sources expressed concern with many tenets of the proposal, but a former CMS official and supporter of the initiative said a joint review process would give manufacturers more value out of the user fees they pay FDA to review their products.
Several
courts have ruled that generic drug makers must add safety warnings to their
labels even if brand-name product manufacturers do not include that
information, and now a decision by a New Hampshire jury to award a plaintiff a
$21 million verdict signals that generic pharmaceutical manufacturers may face
major financial penalties if they fail to disclose new data to consumers,
industry sources said.
A consumer
advocate is proposing that FDA consider using Risk Evaluation and Mitigation
Strategies for devices as part of its upcoming authorization of medical device
user fees, a change that would require Congress to amend FDA's REMS authority
beyond drugs. But some industry sources raise concerns that it isn't feasible
to simply translate the approach from the drug to the device arena.
With a number of polls favoring Republicans' chances to take back the House of Representatives, speculation among Washington insiders has turned to the powerful Energy and Commerce Committee, with some GOP staffers and lobbyists suggesting that Michigan Republican Rep. Fred Upton has a better chance of taking the helm than current ranking GOP member Joe Barton (TX), who would need to secure a waiver from GOP term rules to take back the job. An Upton aide confirmed the lawmaker's ambition to the chairmanship, saying he would prioritize reversing healthcare reform and seek a permanent ban on all federal funds for abortions.
As industry
remains wary that comparative effectiveness research could spur the addition of
superiority as a prerequisite to most product approvals, a top FDA drug center
official this week encouraged drug manufacturers to conduct more three-armed
clinical trials, saying that these types of studies help validate trial designs
and could enable superiority claims. However, an industry attorney said
three-armed trials would skyrocket development costs and potentially provide
additional fodder to competitors if the drug fails.
As FDA
officials call for more corporate oversight to curb quality issues associated
with the increased importation of drugs and outsourced manufacturing, the
agency's top regulatory official said those measures will likely be included in
expected drug safety/user fee legislation next year. Michael Chappell, acting
associate commissioner for Regulatory Affairs, said the regulatory emphasis of
pending food safety legislation will most likely translate to a drug safety
measure calling for more oversight of suppliers and outsourced manufacturing.
FDA officials
expect the agency will gain membership in an international pharmaceutical
inspection organization in November, ending a five-year application process to
join the group, officials said this week. Membership would allow FDA to hook
into an international network of regulatory agencies to share resources.
A device
industry trade group told FDA that its members are hesitant to support
continuation of FDA's device user fee program, reflecting what sources say have
been behind-the-scenes discussions by industry officials over whether to
withdraw support for the fees. The remarks by Medical Device Manufacturers
Association President Mark Leahey came at the agency's first public meeting on
the fees, which are up for reauthorization next year.
FDA
Commissioner Margaret Hamburg has selected an HHS reimbursement policy expert
and Inspector General veteran as the agency's top regulatory affairs officer,
exemplifying this administration's focus on enforcement and compliance but
spurring concern from stakeholders over the lack of direct FDA experience,
according to sources and an agency email obtained by FDA Week.
A key device
industry trade association is touting a new study on the 510(k) review process
as indicative of the program's impeccable safety record, but a safety advocate
questioned the group's conclusions and found its interpretation flawed. The
study found that the 510(k) process has resulted in a lower percentage of
recalls than the data-driven premarket approval process.
Sen. Tom
Coburn (R-OK), a staunch advocate of fiscal conservatism that has deterred
passage of legislation lacking budget offsets, has emerged as a stumbling block
to Senate leadership's month-long effort to find floor time for long-stalled
food legislation, sources said. Coburn is not only concerned with costs, but
also does not think FDA can handle the increased responsibilities granted in
the legislation, such as mandatory recall authority and establishing a
traceability system.
FDA's
proposal to classify electronic cigarettes as drugs -- thereby requiring costly
clinical trials -- or efforts to pull the products of the market could be
detrimental to former smokers who depend on the product, by limiting access and
mandating what could be viewed as unethical trials, sources said. But some
organizations have applauded FDA's efforts to evaluate the safety of the
battery-powered devices that produce a nicotine vapor.
In order to
ensure safety information that may emerge years after product approvals come to
light, consumer groups are pressing FDA to incorporate mandated post-market
Sentinel Initiative studies into the Risk Evaluation and Mitigation Strategies
program, a proposal that the agency will consider once the data query system
becomes fully operational, sources said. Some stakeholders have prioritized
increased use of Sentinel as part of their drug user fees reauthorization
goals, while also pressing the agency to increase its commitment to the
program, although funding constraints could potentially hamper the initiative's
evolution, sources said.
Consumer
advocates are preparing to propose linking generic drug approvals with an oath
not to delay marketing of products, a move that would effectively forbid
companies from entering drug patent settlements that some say cost patients billions
of dollars, according to prepared testimony obtained by FDA Week ahead
of a highly anticipated FDA meeting on generic drug user fees. But a generic
industry source said this strategy doesn't take into account that it is unknown
whether drug patent settlements save or cost consumers money until litigation
nears completion.
The next two
years will present few opportunities to fine-tune the health reform law, even
if Democrats retain control of Congress, a Senate Republican aide told insurers
Wednesday. He said Republicans will have little interest in making it easy for
Democrats to iron out any issues and likely won't be able to pursue some of
their own priorities, meaning that even a Republican majority might have to let
stand provisions it opposes, namely the CLASS Act.
The Agency
for Healthcare Research and Quality is surveying patients on ways to help
communicate results from comparative effectiveness research (CER) to the
public. One-fifth of the funding for the health reform law's Patient Centered
Outcomes Research Institute goes to AHRQ for disseminating research findings.
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