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Drug Safety

On September 19, 2007 the House passed the final version of the Food and Drug Administration Amendments Act of 2007, H.R. 3580, which was signed into law on September 27, 2007 (H.R. 3580). This bill reauthorizes the prescription drug user fee for five years and increases the user fee in order to allow FDA to approve life-saving drugs more quickly.  It would also make the most sweeping safety and regulatory changes to the agency in years, adding new surveillance and safety requirements for drugs after they have been approved and marketed. 

Provisions Promoting Drug Safety:

Has the most sweeping drug safety provisions in years, creating a new program to monitor the safety of drugs after they are on the market.  Up until now, the focus of the FDA regarding prescription drugs has been on studying the safety of drugs before they receive approval to be marketed.  There has been growing concern that, once a drug receives FDA approval, its safety is not monitored.  This bill establishes a new program within the FDA to monitor the safety of drugs after they have been approved and marketed.   Under these drug safety provisions, drugs on the market would be subject to new FDA surveillance and safety requirements.  First, under the bill, FDA would establish a surveillance system to track the adverse effects of drugs on the market.  Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.  Secondly, based on this surveillance, a drug on the market  could then be subject to follow-up FDA studies, at the discretion of the agency.  The bill also requires the FDA to conduct a new study of a drug, seven years after it goes on the market.  In the case of some riskier drugs, there would be regulations limiting prescribing authority to physicians with special training.  

Increases fines for violating FDA safety standards.  In an effort to promote drug safety, the bill also increases the fines for violating FDA safety standards.  Under the bill, prescription drug and medical device companies would be subject to a fine up to $250,000 per violation of FDA safety regulations, and a fine up to $1 million for several violations adjudicated in a single proceeding.  If companies are notified of violations but continue to defy regulations, they would be subject to a fine up to $10 million per violation and a fine up to $50 million for several violations adjudicated in a single proceeding.

Imposes penalties for false or misleading advertising.  In an effort to promote drug safety, the bill also  assesses a maximum penalty of $250,000 for a first offense of a “false or misleading ad” in direct-to-consumer advertising for prescription drugs.  There would be a penalty of up to $500,000 per day for subsequent offenses in any three-year period.

Creates publicly available databases on clinical trials.  As part of its drug safety provisions, the bill also creates two publicly available databases, accessible over the Internet, on the clinical trials of new prescription drugs seeking FDA approval.  The first database would include a registry of ongoing clinical trials, and the second would post the results of clinical trials.  Making this type of information available to the public, including academic experts and other independent observers, will promote the likelihood that safety concerns raised by the data are not overlooked.

Includes stricter conflict-of-interest provisions.  As part of its drug safety provisions, the bill also includes stricter conflict of interest provisions - to better ensure that the FDA is acting on information that is truly objective and is not making decisions based on the personal financial interests of those serving on advisory panels.  Specifically, the bill requires experts serving on FDA advisory panels to disclose all financial conflicts of interest.  Under the bill, the FDA could grant only one waiver per meeting to advisory panel members.  Experts with conflicts of interest but without waivers could present information to the advisory panels, but they could not vote.

Other Provisions:

Increases prescription drug user fees.  The bill reauthorizes for five years the Prescription Drug User Fee Act (PDUFA) - the law that allows the FDA to charge fees to drug companies to expedite the agency's review of drug approval applications.  It increases the user fees, which will be used to increase staffing and provide faster approval of drugs.  It also contains provisions that permit appropriators to provide additional funding for the drug safety program that would allow the fees to be reduced by a corresponding amount. 

Reauthorizes medical device fees.  The bill also reauthorizes for five years the Medical Device User Fee and Modernization Act, which allows the FDA to charge user fees for the review of medical device approval.  It is estimated that the FDA will collect $287 million in fees from medical device companies over five years, just over a fifth of the total cost to the FDA to review new devices.

Encourages development of pediatric drugs and devices.  Finally, the bill includes several provisions to encourage the development of pediatric drugs and devices.   For example, it reauthorizes for five years FDA's authority to require drugmakers to include assessments for pediatric use along with applications for new drugs or new uses for drugs.  These provisions are intended to make more new drugs available to children, who typically represent a much smaller pool of likely consumers than adults.  The bill also reauthorizes for five years FDA's authority to give drugmakers who find new pediatric uses for a medication an additional six months of marketing exclusivity for the drug as an incentive to research new treatments for children.