FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007
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Mr. BURR. Mr. President, I stand here with a heavy heart. Congress had the chance to reauthorize many important programs at the Food and Drug Administration and pass a targeted drug safety bill. Instead, we are passing a massive bill that triples FDA regulation and responsibility, puts clinical data out in the general domain that may be misleading to patients, and contains conflict of interest language that could harm participation on the FDA's advisory committees--a key part of the drug approval process.
I will start with a good part of the bill. This bill reauthorizes many important programs at the FDA, including the pediatric exclusivity program. The Best Pharmaceuticals for Children Act was originally enacted as part of the Food and Drug Administration Modernization Act in 1997, legislation I sponsored on the House side and was reauthorized in 2002. The goal of BPCA is to encourage the study of more drugs in the pediatric population. BPCA provides that incentive by giving drug companies an additional six months of market exclusivity to a product, or pediatric exclusivity, in exchange for conducting voluntary studies of prescription drugs on children.
Since its enactment, BPCA has been viewed as a highly successful program and has produced at least 132 completed studies, leading to approximately 120 pediatric label changes. According to the most recent General Accountability Office study on BPCA, issued March 22, 2007, prior to enactment of the Food and Drug Administration Modernization Act few drugs were studied for pediatric use. As a result, there was a lack of information on optimal dosage, possible side effects, and the effectiveness of drugs for pediatric use. Almost all the drugs--about 87 percent--that have been granted pediatric exclusivity under BPCA have had important labeling changes as a result of pediatric drug studies conducted under BPCA. Exclusivity is working.
Senator DODD tried to change the Best Pharmaceutical for Children Act by decreasing the exclusivity for some drugs. At a Health, Education, Labor, and Pension Committee hearing, witnesses expressed concern about Senator DODD's idea and speculated whether it would decrease the number of drugs studied for pediatric indications. I am pleased that the final bill does not include that misguided change to the pediatric program.
From the beginning of the HELP Committee's consideration of the drug safety issue I recognized the need to clarify existing authority or provide the FDA with a few new authorities in order to improve the interaction between the FDA and drug companies on safety issues. It was clear that labeling changes and clinical trials and studies were two key areas in which Congress should act.
To that end, I offered an amendment during the committee markup that provided the Secretary with additional authority and control over a drug or biological product's approved labeling, including the authority to require the holder of an approved application to make safety-related changes following an accelerated labeling review process. Under the new procedures added by my language, if either the Secretary or the holder of an approved application became aware of ``new safety information'' that the party believed should be included in the labeling, the other party should be notified promptly, and discussions should be initiated regarding whether a labeling change is needed and, if so, the content of any such labeling change.
That construct made sense to me and it made sense to Chairman KENNEDY who passed the amendment by unanimous consent. Given that current practice today is for a company to call the FDA when they become aware of new safety information, I thought it was a good idea to put current practice into statutory law. I want companies and the FDA to talk to each other about drug safety issues.
I support the safety labeling language in H.R. 3580, which reinforces the FDA's broad authority over prescription drug labels. These provisions allow the FDA to mandate changes to a drug's approved labeling whenever the FDA becomes aware of new safety information that it believes should be communicated in the labeling. Although the FDA already has broad authority over drug labeling and must approve all but the most minor labeling changes, this provision will enhance FDA's authority and help to ensure that labeling changes are made expeditiously using a process that facilitates dialogue between the drug company and the FDA. FDA has comprehensive authority over the regulation of drug products, particularly drug labeling, and this provision further accomplishes that goal.
As I said earlier, I have three main concerns with H.R. 3580. First, the bill is a complex web of regulation. It is going to take months, if not years, for drug companies and the FDA to understand all of the new regulations. I supported improving the FDA's authority in two areas: safety labeling changes, and clinical studies and trials. This bill goes far beyond those two areas and sets up a structure called REMS--Risk Evaluation and Mitigation Strategy. The REMS does not add any significant new authority. The FDA currently uses Risk Maps which do the same things as REMS. Now Risk Map regulations, which have never been studied for their effectiveness, are becoming law. It means more paperwork, deadlines, and checkpoints for drug companies, with no guarantee that it will improve patient safety. I do not support regulation for the sake of regulation.
Second, H.R. 3580 expands the scope of the Government's current clinical trials website, www.clinicaltrials.gov, and adds clinical trial results. I understand the desire of some members to make clinical trials transparent and the desire of scientists to have as much access as possible to clinical trial data. But I am very concerned that average citizens will not understand all of the complex scientific information being presented to them and instead of talking to their physicians to understand the data about adverse events, primary and secondary outcomes, and baselines, they will instead avoid taking drugs that could make them feel better or save their lives. I hope that the National Institutes of Health and the Food and Drug Administration are very careful while implementing this title of H.R. 3580. If expanded improperly, clinicaltrials.gov will frighten people, not educate and assist them.
Third, this legislation changes the FDA process for granting waivers for participation on advisory committees. The FDA has 23 advisory committees that meet to discuss applications pending before the FDA and other issues. Currently, only four of those advisory committees have complete membership. Serving on an advisory committee is not a glamorous job, even though we rely on those committees to guide the FDA's approval and regulatory processes. Understandably, scientists that serve on the committees have more to gain from doing their research and making tenure, than working part-time for the Government. Given all of those issues, instead of creating incentives to work on the committees, this legislation makes it more burdensome and complex. People have expressed concern about biased committee members, but the facts demonstrate that the FDA is quite vigilant about screening individuals to serve on the committees. And the FDA has been working on new regulations to strengthen the screening process even more. I hope that we do not see a slowdown in the drug approval process due to an inability to fill the membership of advisory committees.
Senator BROWN and I also worked on language that would help bring new antibiotics and generic versions of old antibiotics to market. At the last minute, that language was stripped out of the House bill in order to pay for a half month of pediatric exclusivity. I hope that Representatives DINGELL and BARTON hold to their promise of moving that antibiotics legislation in the near future.
Overall, I am disappointed that necessary FDA reauthorizations became vehicles for legislation that need more work, are overly broad, and will weigh down the FDA at a time when we need to be helping, not hurting, the FDA.
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