FDA Amendments Act Raises Confidence and Questions

New FDA act reshapes drug development and marketing to restore public trust in pharmaceutical regulation.
Nov 02, 2007
Volume 31, Issue 11

One of the main questions raised by the recently enacted FDA Amendments Act of 2007 (FDAAA) is whether all the many new requirements for assessing drug safety and investigating risks will make manufacturers hesitate to develop any test therapy that exhibits adverse events or formulation problems. Conversely, it may turn out that all the new rules raise public confidence in the US Food and Drug Administration's ability to detect and deal with safety issues, and that will make it easier to bring innovative therapies to market.

One thing is for sure: it will be some time before pharmaceutical companies can obtain a clear answer. What is clear right now is that manufacturers will be paying much higher user fees in the FDA fiscal year that began Oct. 1, 2007. Congress managed to approve FDAAA before PDUFA IV expired on Sept. 30, 2007. And the last-minute rush forced the legislators to compromise on many issues, which could have long-term ramifications for agency operations and manufacturer research decisions.

Curbs on drug advertising, stronger label warnings, limited distribution programs, and broad research disclosure requirements may all combine to limit prescribing. This "makes marginal drugs even more risky" for industry research and development programs, observes attorney John Kamp, who heads the Coalition for Healthcare Communications. He predicts that safety or efficacy questions about a product in Phase II may make a company hesitate to go forward.

Jill Wechsler
Conversely, all the new regulatory tools now available to FDA could boost the agency's confidence about its ability to tackle safety issues that crop up after a drug comes to market. Such enhanced authority could make the agency less likely to delay a new approval.

Giving and taking

Overall, manufacturers applauded the government's enactment of FDAAA. In addition to continuing user-fee support for drug approvals, the bill retained incentives for industry to conduct additional pediatric studies, curbed the scope of new penalties for fraud and noncompliance, and kept the door open for direct-to-consumer (DTC) advertising of new drugs. At the same time, FDA gained more authority to control drug marketing and labeling, require postapproval studies, establish active surveillance systems, and make clinical trial operations and results more transparent.

Implementation will be an arduous, time-consuming task. The legislation contains at least 200 specific provisions, noted FDA commissioner Andrew von Eschenbach in discussing next steps for the agency. Delays in finalizing the bill and late additions to the revised user-fee program also put off the calculation of actual user fees for the fiscal year that began Oct. 1, 2007.

In Washington This Month
The job of sorting out many of the new requirements now falls to FDA Deputy Commissioner and Chief Medical Officer Janet Woodcock. She recently took over as the acting director of the Center for Drug Evaluation and Research (CDER) following the departure of Steven Galson to become the Department of Health and Human Services's acting surgeon general. Woodcock implemented the initial user-fee program during her 10 years as CDER director and has been the driving force behind FDA's Critical Path Initiative and campaign to modernize good manufacturing practices.

Unfortunately, FDA is likely to receive few added resources for its efforts to improve the drug-development process. The new Reagan–Udall Foundation established by FDAAA is supposed to award grants to scientists within and outside the agency who are engaged in projects related to the Critical Path Initiative. But FDA is authorized to spend only $1.3 million on the program, and that funding must come from its own tight budget. In addition, little new money is available to spur the development of antibiotics. FDAAA authorizes Congress to provide additional funds to accomplish the complex bill's many goals, but FDA is unlikely to actually get all the money.

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