FDA's request
for more data, but no additional clinical trials, as part of Teva's
biosimilar-like application for Neutroval signals the agency could be amenable
to companies submitting regular biologic license applications with data from
other products en lieu of using the newly created biosimilars pathway, which
some stakeholders view as unfriendly to generics and unworkable pending further
agency guidance, sources said. A Teva official said the firm will continue to
submit these types of applications as BLAs and not as a biosimilar until the
new route is fully developed, a proposition that some industry officials say
undermines the new biosimilars pathway and shows a need for the agency to force
BLA submissions that rely on previous data to be filed as biosimilars.
Device
industry groups and some safety advocates are pushing back against FDA's
proposal to create a subset of Class II devices targeted at higher risk
products, but for differing reasons. A safety advocate expressed concern that
certain devices included under the category should be examined through a higher
standard, while industry asserts that the proposed definition encompasses some
products that should be subject to less stringent reviews.
The device
industry strongly opposes FDA's draft 510(k) reform recommendations to revamp
the "substantial equivalence" definition, increase the agency's 510(k)
rescission authority and limit predicate use, according to comments submitted
this week to FDA. However, consumer and safety advocates generally agreed with
FDA's plans on these issues, or raised no objection to those proposed changes,
while calling for enhanced post-market safety activities.
The
prestigious Institute of Medicine is calling on HHS to establish a national
task force to focus on the acceleration of research and product development for
rare diseases and for National Institutes of Health-funded studies to be
designed to fulfill FDA requirements, the group said in a report issued this
week. Rare disease advocates lauded the recommendations and said they represent
government-wide efforts to focus on neglected products.
Alterations
to an FDA biosimilars meeting notice could provide some insight into agency
positions on several issues associated with implementing its new authority
under the health reform law, including a two-step interchangeability approval
process, the role of trade associations in establishing a user fee and adoption
of the same international non-proprietary name (INN) for biosimilars and the
innovator product, sources said.
Closed door
negotiations between FDA and industry over the upcoming drug user fee
reauthorization have included stark disputes over the agency's call for limited
extensions of review times and industry's request for more mid-review meetings
that address issues usually left until just prior to approval, such as Risk
Evaluation and Mitigation Strategies, according to sources and agency minutes
of recent negotiations. But, the prospect of Republican gains in Congress -- or
even a takeover of the House -- is likely to complicate either proposal due to
stagnant agency funding and lawmaker -- especially GOP -- opposition to
extending statutory review dates, sources said.
The company
producing genetically engineered salmon and industry stakeholders say they are
disappointed by congressional criticism of FDA's assessment of the product, and
plan to provide lawmakers and the public with additional information backing up
the agency's efforts to regulate transgenic fish as a new animal drug. An industry
source also suggested the actions on Capitol Hill appear to be prompted by
political concerns, instead of a clear understanding of the facts.
Consumer
advocates are mixed on a recent Corn Refiners Association citizen's petition
that calls for FDA to recognize "corn sugar" as an alternate name for high
fructose corn syrup -- with one advocate saying that a name change would
clarify confusion, while another stresses that the "corn sugar" moniker is just
an effort to re-brand a stigmatized product. Regardless of their disagreements
over the HFCS name change, consumer advocates agree that "corn sugar" is not an
appropriate substitute.
FDA
Commissioner Margaret Hamburg's efforts to bolster the agency's scientific
capabilities include prioritization of improved clinical trial designs,
strengthening the antibiotic pipeline, enhancing gene-based testing, real time
Sentinel post-market monitoring and boosting reviewers' ability to determine
bioequivalence for genetic drugs, she said this week as she unveiled a new
regulatory science priorities document, which calls for more collaboration
across government, industry and academia.
Alaska
Republican Rep. Don Young last week joined the debate over genetically
engineered salmon by introducing two bills -- one preventing FDA approval of
genetically engineered fish, and the other requiring labeling on any GE salmon.
The former bill goes further than legislation on the issue penned by some other
lawmakers addressing labeling, as well as recent bipartisan letters from House
and Senate lawmakers calling for the agency to halt the approval process of
AquaBounty Technologies' genetically engineered AquAdvantage Salmon.
FDA is
sending a confusing message to consumers with qualified health claims that
reject the agency's support for possible benefits of the dietary supplement
selenium that are now permitted after a legal settlement between the agency and
product manufacturers, industry and consumer advocates said. The selenium claim
includes a disclaimer stating that FDA does not agree with the claim.
Negotiations
broke down last month between drug testing kit makers and FDA over whether the
products require 510(k) clearances or even fall under the agency's
jurisdiction, with manufacturers now lobbying lawmakers to get involved and
prevent the agency from taking enforcement action, according to an informed
source and a letter sent last week to FDA.
In a sweeping
new report issued Friday (Oct. 1), FDA identifies several regulatory,
scientific, enforcement and oversight priorities for the next five years,
focusing on rapidly evolving science and increased globalization. Separately,
the FDA device center also released a list of guidance documents that it
intends to consider developing in fiscal 2011.
Democratic
leaders on the House Energy and Commerce Committee are worried that the health
reform law's Patient-Centered Outcomes and Research Institute (PCORI) could
influence studies conducted at the National Institutes of Health and the Agency
for Healthcare Research and Quality, blurring the line between special interest
groups recognized on PCORI's board and government scientists, a congressional
aide said. Committee staff plan to meet with NIH officials to discuss the
concerns. Giving the yet-to-be-appointed PCORI methodological committee a
bigger role potentially could mute special interest groups' influence over
federal agencies' research agendas, the aide says.
Members of
the physician community say it is important for the health reform law's new
comparative effectiveness institute to quickly unveil some patient outcome
research results so as to cement public support for the initiative and prevent
its political erosion over claims its main goal is to limit reimbursement. A
recent poll shows that 62 percent of the public supports CER, and demonstrating
early on that the research could be used to help choose the best treatments
would go a long way toward maintaining the public's support, according to
physician experts who spoke at a Health Affairs conference on Tuesday (Oct. 5).
Efforts to
increase product development for neglected tropical diseases will have to
extend beyond the traditional pipeline for such drugs and devices, with FDA
taking on a mentoring role for non-traditional developers, according to
presentations at a recent agency hearing that focused on drawing out ideas for
expanding development efforts and building on the orphan drug program and the
drug voucher program.
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