The U.S. Senate and House of Representatives passed, and President Bush
signed, compromise legislation in late September to give the Food and Drug
Administration (FDA) increased resources and power to regulate safety of
prescription drugs (see also Law Ensures Public Access to Clinical Trial
The Prescription Drug User Fee Act (PDUFA) was originally enacted in 1992
to fund timely new drug approval reviews within the agency and was up for
review and renewal by the end of September.
In renewing PDUFA, the FDA Amendments Act (FDAAA) (HR 3580), Congress
raised the user fees paid by pharmaceutical companies to the FDA by 25
percent, with these fees authorized through 2012.
According to a summary of the FDAAA prepared by the House Committee on
Energy and Commerce, the increased user fees will fund enhancements in the
agency's review process for new drug and product applications, safety reviews,
and postmarketing surveillance, including increased monitoring of
direct-to-consumer drug advertisements.
The FDAAA also reauthorizes the Pediatric Research Equity Act, which gives
the agency the power to require pediatric studies to be included in certain
new drug applications. The Best Pharmaceuticals for Children Act, which
extends marketing or patent exclusivity for an additional six months to
manufacturers who comply with FDA's requests to conduct pediatric clinical
trials, has been renewed as well.
Safety alarms associated with a number of approved,"
blockbuster" drugs such as rofecoxib (Vioxx) and rosiglitazone
(Avandia) have made headlines in recent years and caused much criticism of the
FDA's ability to protect the public. Responding to those concerns, the FDAAA
contains provisions that seek to strengthen the FDA's regulation of the safety
of marketed drugs. For example, the agency now has clearly defined authority
to request that postmarketing clinical trials be conducted by manufacturers,
demand labeling changes, and impose monetary penalties for violations.
However, the bill stops short of allowing the agency to ban television ads
that are considered misleading or false, a proposal in an earlier version of
the bill that was opposed by broadcasters, the advertising industry, and the
pharmaceutical industry, as reported by American Public Media's news program"
The FDAAA retains a provision in an earlier House version of the bill that
would expand the current online clinical trial registry, operated by the
National Library of Medicine, into a searchable public clinical trial databank
and place the director of National Institutes of Health in charge of making
specific rules about this process. All U.S. clinical trials will be required
to register prospectively in the databank, and brief results of clinical
trials conducted on approved drugs will also be required to be posted.
The FDAAA can be accessed at<http://thomas.loc.gov>
by searching on the bill number, HR 358; a summary of the bill prepared by the
House Committee on Energy and Commerce is posted at<energycommerce.house.gov/FDA%20Amendments/Summary.pdf>.▪