The decision
by GlaxoSmithKline -- after pressure from FDA -- to cease enrolling additional
patients in a controversial comparative safety trial has not silenced critics
of the study who say any prescribing of the diabetes drug Avandia puts patients
in undue harm and are calling on the agency to mandate a complete halt to the
trial. Drug safety advocates fear the Avandia study -- one of the first
mandated by FDA using new post-market safety authority it gained in 2007 --
could tarnish FDA's ability to require post-market safety trials in the future,
and are calling for future comparative safety trials to be conducted earlier or
in the premarket setting.
In order to
address concerns highlighted in a recent government audit that companies
manufacturing direct-to-consumer genetic tests are providing inaccurate results
to the public, FDA is weighing a novel regulatory approach that would still
increase oversight but would not require individual product-makers of such
tests to submit data to the agency for every new indication, according to a top
agency official. Examination of a new approach to the regulation of these tests
coincides with calls from lawmakers and industry that standards would help
ensure the validity of claims by manufacturers of these diagnostic products.
Industry
officials, including leadership at the Advanced Medical Technology Association,
are calling on FDA and CMS to improve coordination to prevent mixed messaging
as part of the competitive bidding process, with FDA recently acknowledging
divergent focuses from the two agencies, according to informed industry
sources. The disconnect -- with CMS focusing on lowest prices of products, and
FDA stressing more support services -- leads to planning confusion for
manufacturers of sophisticated therapy products for the home, sources said.
Lawmakers,
industry and patient advocates are all examining methods to streamline FDA
reviews of orphan products and are also considering economic incentives that
would spur development of these drugs and devices, with a Senate lawmaker
planning legislation to expand a new drug review voucher program to help
encourage manufacturers to focus on rare diseases. Meanwhile, the medical
device industry continues to seek more FDA guidance on humanitarian device
exemptions, with a top FDA official expressing openness to a device industry
call for a guidance on orphan product development while also urging product
manufacturers to meet with agency staff while conducting research on medical
products.
Days before
House Democrats put forward sweeping legislation that would give FDA
unprecedented regulatory authority over cosmetics, the personal care products
industry released its own legislative proposal that seeks to head off the
effort with a moderate plan that would give the agency brand-new powers over
their goods but on a much narrower scale.
A letter sent
to Senate leadership on Wednesday (July 21) from a coalition of biosecurity and
national disease prevention advocates called on the Senate to remove language
from the House-passed Supplemental Appropriations Act that would use unspent
pandemic influenza dollars and the Project Bioshield Special Reserve Fund to
pay for other spending priorities.
FDA's recent
pronouncement that it intends to increase monitoring of laboratory developed
tests is likely to result in a tiered, or risk-based, oversight strategy that
would evaluate diagnostics differently based on the potential for adverse
events associated with an inaccurate product, a top FDA official said, adding
that retrospective studies could serve as a legitimate tool to assess products
for efficacy. The agency held a two-day public meeting this week on how to regulate
these genetic tests, with laboratories cautioning that FDA oversight could
threaten innovation and manufacturers of traditional devices saying that LDTs
should face the same regulations as their products.
A newly
formed coalition -- which seeks to represent application developers, networks,
smartphones and other related technologies -- is focusing on product claims and
uses as it moves forward drafting a proposed guidance that would delineate when
devices and technologies fall under FDA jurisdiction and whether accessories
are subject to FDA oversight. As a preview the coalition will present the
issues it views as priorities at a two-day government hearing next week on
mobile health technology oversight.
FDA has
entered into a blanket purchase agreement with management consulting firm
McKinsey & Company to provide what the agency has called "business process
improvement" and "strategic management consulting services." All FDA centers
are able to use the BPA to create their own customized consulting order, with
the ordering window stretching five years starting this past April.
After years
of FDA cross-training its inspectors to be able to survey drug, device and food
product manufacturing, the agency's first crop of food-only inspectors are
close to being deployed, said a food safety source who recently attended a
meeting with top FDA officials.
A House
appropriations panel approved last week a measure to speed public and industry
access to research conducted by government scientists or studies using federal
funds, a move heralded by some lawmakers, industry and other stakeholders as
fueling transparency that would help spur product development through shared
knowledge and easier access to science.
Even though a
Senate panel cleared Thursday (July 15) an FDA spending bill at the same level
as the president's request of $2.5 billion, though $55 million less than
proposed last month by a House subcommittee, the Senate lawmakers upped
appropriations in some drug center activities by drawing on funding from the
commissioner's discretionary spending slush fund. However, the Senate
Appropriations Committee's reluctance to follow the House lead and boost
spending beyond the administration's request drew the ire of stakeholders who
are lobbying Congress and the administration to make FDA an exception to budget
constraints by bolstering the agency's budget.
Congressional infighting between two top Democrats integral to the food safety debate signaled frustration over the Senate's delay in considering legislation that has languished in the upper chamber for months, allowing new cost concerns to creep into the discussion and fuel lawmaker reluctance to pass the bill. Finger-pointing accelerated in an exchange of heated letters Monday (July 19) on the cause of Senate delay and whether an amendment on the controversial chemical bisephenol A is hampering consideration of the measure.
A story that ran in FDA
Week on June 23 errantly described a draft guidance on conflict-of-interest
disclosures as having an impact on FDA's difficulties in filling advisory
committee vacancies. The draft guidance pertains to COI screening for members
before individual committee meetings. The vacancy rate is not affected by
whether members can or cannot attend a particular meeting of the committee.
After a panel of experts echoed his concerns this week, a top House Energy and Commerce Republican stepped up his charge that Democratic leadership on the committee is ignoring the fact that FDA may be struggling with safety concerns surrounding the healthcare reform law provisions that created the accelerated biosimilars approval pathway.
|
|
|
|
|
|
