September 28, 2007

Earlier this week, Matthew Herper of Forbes magazine published a thoughtful article arguing that the passage of the FDA Amendments Act (PDUFA IV, for those of you who follow inside baseball) is the most important FDA reform in a decade because it will give the agency real powers to protect drug safety and improve transparency - thereby restoring its reputation.

Herper thinks that, in the long run, a stronger FDA is a win for industry, because when the agency's reputation is weakened its ability to approve new medicines in a timely manner declines. Herper says that:

The focus was creating a more transparent FDA with the power to better study and regulate drug safety. Legislators were probably smart, in the end, to stick with the issues they had debated the most and approve a bill that is uncontroversial now but would have seemed like a radical step three years ago.

Hopefully, the changes will strengthen the FDA, renewing the public's shaken faith in the safety of medicines. Drug makers could wish for nothing more.

I do agree with Herper that the FDA's reputation has been under fire in recent years, and that this makes the agency risk averse when it comes to approving new medicines. I also agree that the postmarket surveillance of prescription drugs was due for a significant overhaul. But I disagree that the legislation will do much, if anything, to improve the agency's standing in the public's mind, largely because of dynamics that are outside of the FDA's control.

As the Avandia crisis has shown, the FDA's ability to adjudicate drug safety data has been preempted by outside analysts and medical journals (think: New England Journal of Medicine) with their own regulatory agendas.

For the FDA, the new environment can be summed up in five words: "if it bleeds, it leads." In other words, the FDA has been put into a reactive mode by outsiders who aren't going to wait for the FDA to parse complex data before crying wolf to the media and Congress. As a result, the FDA will be under intense pressure to make drug safety decisions before the whole picture is really available.

Nothing in today's legislation is going to fix that. If anything, the new labeling powers, powers to require Phase IV clinical trials, and new clinical trial database will put even more pressure on the agency to preempt potential safety problems by ratcheting up regulations and reporting requirements.

For a counterpoint to Herper's article, take a look at this incisive essay by John Calfee, a senior fellow at the American Enterprise Institute. Calfee argues that,

[The new legislation] will increase FDA power, extend its reach beyond normal bounds, and expose FDA personnel to yet more scrutiny and criticism for safety problems no matter how unpredictable. There will be no tests or benchmarks for how well this new regime will work. In a world of ever more extensive post-approval clinical trials and database dredging, there is no reason to think drug safety data will become more reassuring or less alarming as time passes. The FDA will find it very difficult to retreat from any sort of regulatory expansion.

Hopefully, new scientific advances will help make this top-heavy, cumbersome regulatory structure obsolete. In the meantime, I agree with Calfee - we can expect new drug approvals to get worse before they get better.

Posted by Paul Howard at September 28, 2007 03:09 PM

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