The pharmaceutical industry's three top trade groups have informed lawmakers they have concerns with Democrats' draft drug safety legislation, particularly that the measure permits collected fees to be used for non-foreign inspection-related issues, leaves many elements of the fees unanswered and does not fully protect confidential information. The groups, in comments prepared for a canceled Capitol Hill hearing, urged lawmakers to consider exempting certain investigational products from the legislation's requirements and said a third-party audit program and improved international coordination could help support the bill's foreign inspection program.
Sen. Tom Harkin (D-IA) questioned this week whether FDA has enough resources to properly tackle biodefense countermeasures development and said he plans to examine whether to strip the agency of some of its duties, amid White House efforts to boost some of FDA's biodefense funding and an HHS proposal to enhance the agency's role in the area. In order to enhance the agency's medical countermeasures program, a biosecurity advocate suggested that FDA create a specific center dedicated to addressing the issue, with Harkin expressing some interest in the idea.
A key Senate lawmaker chastised HHS this week for its plan to redirect Project Bioshield procurement funds to the Department of Defense and raised concerns that the U.S. is falling behind in developing cell-based vaccine technologies, despite stating that HHS' proposal to strenghten its medical countermeasures enterprise is generally a good plan.
Mandatory recall authority would have allowed for a quicker response and better oversight of Johnson & Johnson's recalls of children's medicines and Motrin, a top agency official told lawmakers Thursday (Sept. 30). Mandatory drug recall authority is a core tenet of recently drafted drug safety legislation that is being prioritized for passage by key lawmakers.
FDA's highly
watched comparative effectiveness research program is now on the verge of being
fully operational, with the agency contracting Johns Hopkins University to lead
a program that will help answer questions on patient sub-populations and
classes of products through the Partnership in Applied Comparative
Effectiveness Science initiative, sources said.
House and
Senate lawmakers are calling on FDA to halt its consideration of whether to
approve genetically engineered salmon and weigh a new regulatory framework to
tackle the issue. They raise concerns with the animal drug approval process the
agency used, along with safety and environmental issues. Senate lawmakers sent
a letter to FDA commissioner Margaret Hamburg on Tuesday (Sept. 28), while Rep.
Frank Pallone (D-NJ) sent a letter to the agency last week. A letter with a
similar objective was also endorsed by at least 20 House lawmakers.
Collaboration
between FDA and the Consumer Product Safety Commission on infant sleeping
devices resulted in a crackdown on the products' manufacturers, now requiring
them to submit 510(k) applications for marketing clearance, with a top FDA
official signaling that the inter-agency efforts could result in more
enforcement actions.
A broad swath
of stakeholders -- including members of the drug industry, consumers and drug
stores -- are resisting FDA's position that the agency cannot pre-review all
drug information inserts under a new plan to develop a single document that
would be distributed with medications, they told agency officials this week.
Instead of lacking an FDA review of the proposed single document Patient
Medication Information (PMI) inserts, stakeholders suggested examining new user
fees or a tiered approach that would gradually review the consumer-oriented
information based on risk and usage.
A key House
lawmaker introduced legislation Wednesday (Sept. 29) that would mandate
labeling on genetically engineered salmon and cloned animal products, with the
bill emerging as the agency weighs approval of transgenic salmon and after it
held a public meeting on the labeling issue last week. Consumer advocates say
they generally support the legislation, but remain more concerned that FDA will
move forward to approve the transgenic salmon.
As FDA
evaluates transitioning the various types of patient drug information inserts
into a single type of document, the agency could consider including some
comparative effectiveness research information for consumers as identified in a
template developed by two prominent scientists, sources said. A consumer
advocate said minimal comparative information should be included to keep the
document simple, while an industry source said the proposed development of
Patient Medication Information (PMI) documents should not include that type of
data.
A recent
settlement with FDA over qualified health claims for the dietary supplement
selenium could set the bar for other nutrient-specific claims and permit short
qualification claims that fit on packaging, according to a free speech attorney
who has been working on the case. The agency entered negotiations with the
Alliance for Natural Health following a May court ruling that FDA had erred in
rejecting selenium health claims.
A regulatory
watchdog group and industry representatives are expressing concern with how a
new FDA menthol advisory panel is proceeding, contending that agency data for a
forthcoming report is flawed and could set the precedent for using inadequate
information for other tobacco-related reports. The panel, whose members are
mostly non-governmental experts, is charged with evaluating how the use of
menthol in cigarettes affects smoking patterns.
After facing
a handful of technological hurdles deploying its intricate import safety system
due to information technology pitfalls, FDA has refurbished its IT
infrastructure and was set to deploy the tools to additional ports by the end
of September, an FDA official said in an e-mail. The system, which was
originally only pilot-tested on seafood in a handful of ports, has also begun
inspecting drug and device imports, although the full potential of the system
will not likely be realized for a while, sources said.
New FDA
guidance outlining recommendations for data collection on suicidality during clinical
trials will be an improvement over past retrospective reporting and will give
FDA a better basis to make regulatory decisions, researchers said.
CMS officials confirmed Thursday
afternoon that all brand-name drug makers have signed contracts with CMS to
provide a 50 percent discount for scripts provided in the Part D coverage gap
during 2011. Deputy CMS Administrator Jonathan Blum said, however, that some
companies that provide repackaging and relabeling of drugs have decided not to
sign the agreement. Blum told Inside Health Policy that top clinical
experts at the agency have advised that these contracts were not necessary
since patients will still have access to all branded products next year.
Congress'
continuing resolution spending measure that will fund the government through
Dec. 3 at fiscal 2010 levels complicates all federal agencies' ability to hire
more staff and will therefore likely impact FDA's medical product review and
food safety efforts, sources said. An FDA official said the CR will not impact
the fiscal 2011 user fee program.
|
|
