June 21, 2007
FDA Reform Bill Goes to House Floor
The House Energy and Commerce Committee late today passed the Food and Drug Administration user fee reauthorization bill that slightly improves the ability of the agency to ensure new drugs are safe and well-monitored once on the market.
On the upside, the bill includes $225 million over the next five years for beefing up the agency's safety department. This was also included in the Senate-passed bill, and would enable the beleaguered safety department to conduct a lot more studies of problematic drugs once they've entered mass use.
The bill also includes a requirement to register all late stage clinical trials and their results. This is also in the Senate bill, and should help independent researchers and consumers -- not to mention the FDA's internal reviewers -- conduct many more meta-analyses of widely used drugs that may have safety problems.
While the bill gives the agency increased powers to levy fines for misleading ads, the Democratic-controlled House caved into the pharmaceutical and broadcast industry lobbies by refusing to give the agency the power to impose a three-year moratorium on direct-to-consumer ads.
On the conflict of interest front, the Republicans tried to repeal a clause that will limit the agency to appointing just one scientist with a conflict of interest onto any advisory committee. The FDA usually follows the advice of its outside advisory panels, but in recent years, nearly a quarter of all advisers (mostly academicians) have had ties to companies regulated by the agency.
Assuming the one-waiver-per-meeting clause stays intact through the full House vote, which is expected later this summer, expect a confrontation with the Senate in conference committee. The Senate bill has no limitation on the number of waivers the FDA can grant.
The bill also included an amendment offered by Bart Stupak (D-MI) that beefs up the adverse event reporting system and pushes the agency to require that companies complete clinical trials promised by companies at the time their new drugs get approved. About three-quarters of such promises never get fulfilled.
The bill also included a provision that all direct-to-consumer ads contain an 800 number where consumers can report adverse events.
All in all, it's a lot better than the Senate bill, and a lot better than the status quo. The action now shifts to the full House floor before it heads to conference. Look for a lot of behind the scenes lobbying by the pharmaceutical industry lobby to push the final outcome in the Senate's direction.
The House subcommittee also caved by removing this sentence from the bill:
“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law.”
This would have simply reaffirmed the status quo that FDA regulation and state civil liability co-exist, as they always have.
Since the FDA preemption arguments come down to an interpretation of the intent of Congress, this opens the door further to those who argue that the FDA regulation implicitly preempts state law. Congress had an opportunity to say otherwise. It failed to do so.
I wish I could be more positive. But I believe there will be H to pay for this deletion. The drug disasters we have already seen will look like very small potatoes once the accountability provided by civil liability disappears. Upcoming rulings in the current Supreme Court are now more likely to lead to that result.