FDA Week

FDA Plans Meeting On Key Biosimilar Issues, Weighs Role Of Trade Groups

2010-09-24T01:30:01Z

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.

Consumers Diverge On GE Salmon Labels And 'Material Difference'

2010-09-24T01:30:01Z

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.

Consumers Still Question Safety Of GE Salmon, Point To Panel Discussion

2010-09-24T01:30:01Z

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.

Mylan Runs Counter To Other Generics With Multifaceted User Fee Plan

2010-09-24T01:30:01Z

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.

GAO Taps VA For CER Board, Consumer Advocate Upset FDA Not Chosen

2010-09-24T01:30:01Z

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.

DOJ Joins Rapamune Off-Label Suit As House Probes Issue

2010-09-24T01:30:01Z

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.

Grassley Likely To Shift FDA Oversight To Enforcement In The 112th

2010-09-24T01:30:01Z

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.

FDA Proposes Avandia REMS To Limit Use, Won't Pull Drug

2010-09-24T01:30:01Z

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.

House Panel Passes Updated Bill Assessing Role Of Women In Clinical Trials

2010-09-24T01:30:01Z

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.

FDA Solidifies CER Infrastructure, PACES Award Days Away

2010-09-24T01:30:01Z

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.