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
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.
"Instead of having something like a Vioxx explode, and then an investigation into the side effects and who knew what when, you can very analytically track side effects as they come up. This will help alleviate some of the surprise side effects that cause headlines," he said.
Trial results databank
Another high point of the bill is the expansion of the existing clinical trials registry databank and, in a victory for consumers, a new databank for trial results. Both will be available to the public on the Internet.
Requiring the posting of clinical trial findings "makes sure that all the data is out there, regardless of the trial results," Dr. Bailes said, noting the obvious advantage to researchers and clinical oncologists. And a registry of all company-sponsored clinical trials should make it easier for patients to locate studies. "That certainly is the intent," he said.
Conflicts of interest
The new law requires FDA advisory committee members to disclose all potential financial conflicts of interest related to a committee's actions. The agency will also have to cut back on the number of conflict-of-interest waivers it grants committee members. The bill calls for a decrease in waivers of 5% annually through FY 2012 to achieve a total 25% reduction in the number of waivers.
Another provision requires the agency to place on its website the minutes of all negotiations with industry and advocacy groups.
The bill will also affect what people see on television. FDA will now be able to preview TV prescription drug advertisements aimed at consumers.
A new foundation
One of the bill's less publicized provisions is the creation of the Reagan-Udall Foundation, a public-private partnership to investigate new ways to evaluate drug development and manufacturing, and the effectiveness of drugs, devices, and diagnostics. This initiative could prove of significant importance in streamlining drug approvals.
"The cancer research field will benefit from this because it adds more cutting-edge science to the FDA approval process," Mr. Bernstein said. "Sometimes it takes FDA some time to get acquainted with new technologies. The hope is that the foundation will help FDA in approving novel devices, biologics, and drugs that in the past it has been slow to advance."