WASHINGTONThe FDA Revitalization Act, with more than 200 specific provisions, will allow the agency to boost its manpower and play a more active role in ensuring drug safety. The bill was signed into law on September 27.
The most important immediate effect of the bill is its provision for a 5-year extension of the Prescription Drug Users Fee Act (PDUFA), ensuring that no PDUFA-funded jobs at FDA will be lost. The Medical Device User Fee and Modernization Act (MDUFMA) was also extended. These two programs account for nearly one-quarter of FDA's annual budget.Further, the bill authorizes an increase in the drug and device fees collected by FDA through these programs. Fiscal year 2008 fees will total $392.8 million for prescription drugs alone, $87.4 million more than FY 2007. The bill also provides an additional $225 million in user fees to be collected over 5 years and used specifically for drug safety activities, including hiring more personnel.
Improvement in drug safety is the main focus of the bill, and the centerpiece of this effort is the establishment of a computerized system to search pharmacy and insurance records for possible adverse events of already approved drugs. The registry will ultimately include a database of 100 million patients.
If the database shows a possible problem, FDA will now have greater powers to force drug companies to conduct postmarketing studies, and if those studies do not answer the safety questions, the agency can demand additional clinical trials. If new adverse events are verified, FDA can require the manufacturer to change the drug labeling.
"FDA can impose new sanctions or fines if certain postmarketing studies are not carried out," said Joseph S. Bailes, MD, chair of ASCO's Government Relations Council. "Having said that, FDA has the ability to work with companies if they run into extenuating circumstances when they are doing postmarketing studies. This should be good for practicing oncologists by helping new drugs get on the market."
Stricter postmarketing policies that require more detailed reporting of adverse events should help reduce major outbreaks of severe adverse events, added David Bernstein, PhD, senior science policy analyst for the American Association for Cancer Research.