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.
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.
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.
In Washington This Month
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.