The regulation of drugs has evolved from 1840 when the Drug Import Act was enacted to the present day when the Food and Drug Administration (FDA) regulates the production and distribution of pharmaceuticals.  The Drug Import Act made it illegal to import dangerous drugs into the United States, but did not contain a clause making it illegal for American pharmaceutical companies to produce dangerous drugs.  The FDA imposes a multi-step process for the approval of drugs in the United States which includes several phases of clinical trials.   

The regulation of pharmaceuticals does not cease when a drug is released to the market.  The pre-market review of drugs is limited and, therefore, post-market surveillance is extremely important for the health and safety of consumers.  Post-market surveillance helps detect rare side effects that may not be identified during pre-market clinical trials since the number of participants in clinical trials is small relative to the actual number of patients who are prescribed the drug after it is released on the market.  Due to the relative small number of participants in clinical trials, post-market surveillance is also necessary to detect long term effects, adverse drug interactions, and how different demographic groups react to the particular drug.

Several regulatory issues are associated with the post-market surveillance of pharmaceuticals.  First, it is mandatory for manufacturers to report adverse drug reactions; however, it is voluntary for clinicians to report them.  Due to the voluntary nature of reporting, on average, only 10% of adverse drug reactions are reported by clinicians.  Second, post-market clinical trials are required for some drugs but rarely enforced.  Third, the post-market surveillance division of the FDA has limited funding and political power.  Removing drugs from the market creates an institutional conflict of interest for the FDA.

It is crucial that steps be taken to improve post-market surveillance. Numerous steps have been proposed, however each has its own advantages and disadvantages.  Forming an independent agency to regulate drugs after they are released on the market has been proposed to Congress.  Creating an independent agency would help eliminate the FDA’s institutional conflict of interest when drugs are removed from the market, but it would create an expensive new bureaucracy.  Imposing conditional new drug approvals and mandatory post-market testing would also enhance post-market surveillance efforts, although enforcement might be difficult.  Mandatory reporting of adverse drug reactions by clinicians, as well as more comprehensive reporting and analysis of post-market data would be less controversial steps toward better post-market drug regulation.

 
Denise Doyle
Master’s student in Pharmacy Administration
University of the Sciences in Philadelphia