Wednesday, November 21, 2007

Uncertainty Surrounds FDAAA Implementation

The recurring joke at the Food & Drug Law Institute’s November 16 conference on implementation of the Food & Drug Administration Amendments Act was that no one knows what to call the law. The acronym (FDAAA) is decidedly unfriendly, prompting pronunciations ranging from “F-D-triple-A,” to “fuh-DAAAA,” to (our favorite), “F-D’oh.”

The uncertainty about what to call the thing is funny. The uncertainty about what some of the key provisions mean for FDA and industry is no laughing matter.

The FDA speakers at the FDLI conference ended up raising at least as many questions about the new law as they answered. Here are just a few key ones.

(1) When will FDA be able to spend the new user fees it is collecting under the bill? Hard as it may be to believe, the new Prescription Drug User Fee Act, negotiated over the course of 2006 and enacted essentially intact in FDAAA this year, has not yet given FDA the raise it so desperately wanted. FDA started collecting the fees at the new, 25% higher rate on October 1, but because Congress has not yet passed an appropriations bill for the agency, it can’t actually spend the money. FDA Chief of Staff Susan Winckler told FDLI that the agency should be able to cope with the current budget situation for the rest of the year, but it will definitely struggle to meet new performance goals if it doesn’t get authorization to spend the money by the first quarter of 2008.

(2) When do sponsors have to file Risk Evaluation & Mitigation Strategies for drugs currently covered by risk management programs? March 24. Or September 24. It depends how you read the law. FDA Chief Medical Officer Janet Woodcock said that issue will be resolved by the agency’s chief counsel. Since the REMS authority is the centerpiece of the new law—and since it is by no means clear to sponsors what products are going to be covered by the REMS provisions—that is a pretty important deadline.

(3) Will all Phase IV commitments be mandatory under FDAAA, or just ones that FDA considers most critical? “I hadn’t thought about that,” Woodcock said. Typically, new drug approvals include a host of different types of post-marketing commitments, Woodcock noted, some of which are more important than others. But at this point FDA has no idea whether it plans to make all post-marketing commitments mandatory—and hence subject to new enforcement authorities included in the law.

(4) Will the new direct-to-consumer ad user fee program get off the ground? It looks like a close call. We delved into this one already, so we won’t repeat ourselves. (Click here.)

(5) What on earth did Congress mean to do by revising the Citizen Petition rules? A three person panel at FDLI, including FDA deputy associate general counsel Jeffrey Senger, spent a good while parsing the language. The section is clearly meant to address concerns that petitions are used by brand manufacturers to delay generic launches. But how will it work in practice? There are lots of "thorny" questions; “I don’t have answers,” Senger said. “Truly the courts will determine many of them.”

So there is plenty of uncertainty ahead for industry as it awaits decisions about FDA on the new rules for drug safety and other sections of FDAAA. FDA is plowing through the issues, and Woodcock pledged that the agency will make it all work. “I am not a lawyer, but I am an implementer,” she told FDLI. “We will be doing these things in the timeframes envisioned by the law.”

Some progress is clear: new requirements for registration of clinical trials take effect December 26, and the National Library of Medicine will have the system ready for industry to start using on that date. The new user fees are in place, even if FDA can’t spend the money yet. And discrete steps—like forming a new internal pediatric review committee and an external risk communication advisory committee—are done.

More importantly, it sure sounds like FDA thinks it can implement the key REMS section without any new guidance or regulation. “I don’t see a lot of regs coming from this,” Woodcock said, noting that FDA already has guidances on risk management plans in effect.

And, most significantly of all, it is clear that the new legislation is going to be implemented with an eye towards making the drug safety system work better for everyone. FDAAA signals a “new phase in drug regulation,” Woodcock said. The new authorities are “pretty groundbreaking.”

But, she added, “it doesn’t diminish our commitment to make safe and effective drugs available in a timely manner.” FDA will use its new powers “judiciously.” And, she said, the new tools “may help ensure that treatments get to and remain on the market.”

If only industry could be sure about that....

1 comment:

Anonymous said...

While some uncertainly may surround other FDAAA provisions, implementation of Title VIII ("Clinical Trial Databases"), which expands , is progressing (mentioned in the paragraph 10).

The new 42 U.S.C. 282(j)(2) calls for additional registration requirements for applicable drug and device clinical trials at within 90 days of enactment (by 12/26/07). Information about these new requirements is available at