House Committee Passes PDUFA Bill
3 CommentsBy Ed Silverman // June 21st, 2007 // 7:50 pm
As the day drew to a close, the House Energy and Commerce Committee signed off on safety reforms, including agreement on $225 million in user fees. The final mark up includes requirements for drugmakers to register most clinical trials and the FDA to make public all transcripts of talks with industry; and authorization for the FDA to change labels, conduct post-approval safety studies and increase fines for false or misleading ads.
The panel beat back attempts to weaken the legislation on conflicts of interest on drug advisory boards and clinical trial results requirements, according to Consumers Union, which sent out a release this evening. (As soon as we can link, we will do so).
The House bill included some measures that expanded drug safety beyond the Senate, including:
- Limiting conflicts of interest waivers on FDA advisory committees to one per panel. Currently, the panels that recommend drugs for market often include several members with financial ties to the company whose drug is up for approval, and the FDA routinely waives the conflict laws. The Senate bill did not limit the number of waivers.
- An amendment by Bart Stupak, a Michigan Democrat, directing that safety funds are spent to use the data collected by the adverse event reporting system, make public any office of drug safety consultations with the Office of New Drugs, and clean up the backlog of hundreds of unstarted clinical trials.
- Requiring all DTC ads to carry an 800-number and Web site address where consumers can report adverse reactions to the FDA.
- Allowing consumer and patient members to be involved in the next round of talks between the industry and the FDA on how user fees should be collected and spent to approve new drugs. An amendment was also approved requiring a public transcript of the negotiations, which currently are held behind closed doors.
- Providing somewhat more meaningful penalties for violations of FDA safety laws. The House Civil Monetary Penalties and penalties for repeated false and misleading ads are higher than what’s contained in the Senate bill.
- Requires a review of a drug’s safety in the seventh year after approval, a provision that forces a review of the benefits and risks of a drug at a time when more is known about it.
- Ensure that any health databases used to look for drug safety problems de-identify patient’s personal info.
Prescription Access Litigation
The subcommittee that made many of these changes also made another important, and negative change — it removed a provision that would have clarified that the FDA’s approval of a drug does NOT automatically preempt state law court cases alleging that a drug injured people or that a drug company failed to warn patients about known risks. The FDA has been arguing for several years that its authority preempts just about any state law claim, which contradicts years of prior policy, core principles of preemption and common sense.
We at PAL covered this on our blog at http://prescriptionaccess.org/blog/?p=32 and http://prescriptionaccess.org/blog/?p=31
Hank
Thanks for update, Ed. The House additions are useful, but I was disappointed that one sentence that had been proposed was deleted. This would have been an explicit statement that the FDA bill would not constitute grounds for preempting state law (which primarily means civil liability).
The exclusion of this sentence - which only affirmed the status quo of having both FDA regulation and civil liability - constitutes a big victory for the FDA preemption folks. All preemption arguments are based on an interpretation of Congressional intent. This was an opportunity for Congress to state its intent. They didn’t.
Friday Blog Roundup « The Pump Handle
[...] Ed Silverman at Pharmalot gives a rundown on the House Energy and Commerce Committee’s markup of the PDUFA bill on drug review and safety, while Merrill Goozner at GoozNews laments what’s missing from it. (In other FDA news, The Olive Ridley Crawl gives the agency 1.5 cheers for its final rule on dietary supplements.) [...]