U.S. Prescription Drug Laws

The United States Food and Drug Administration (FDA), currently a part of the United States Department of Health and Human Services, was formed in 1906. Its many crucial responsibilities include regulating food, drugs, dietary supplements, medical devices and biological products, as well as certain veterinary products, cosmetics and sanitation standards, to ensure their safety. To supervise the production and availability of prescription drugs specifically, the agency currently relies on two major pieces of federal legislation, both of which have amendments: the Prescription Drug Marketing Act of 1987 (PDMA) and the Prescription Drug User Fee Act of 1992 (PDUFA).

History

The Food and Drug Act, also called the Wiley Act, was not only the first federal law to substantially regulate the safety of drugs, but it was also the legislation that officially established the FDA. Signed into law by President Theodore Roosevelt in 1906, it prohibited the interstate sale of adulterated drugs and forbade the incorrect labeling of drugs, too.

Prescription Drug Marketing Act

The PDMA, passed in 1987, put in place various legal requirements aimed at ensuring the safe distribution of prescribed drugs. As a result, the established measures help guarantee that pharmaceuticals are genuine and, effective.

An amendment to the Federal Food, Drug, and Cosmetic Act (FFDCA), the PDMA limits the reach of wholesale drug sub-marketing, frequently linked to the dissemination of counterfeit and ineffective substandard drugs, by (1) restricting the marketing of drug samples, (2) disallowing the resale of certain drugs, and (3) banning re-imported drugs produced in the United States.

Prescription Drug User Fee Act

The PDUFA became effective in 1992 and has since been subject to several amendments and a reauthorization in 2007 that significantly expands its scope. Originally, the federal law permitted the FDA to fund drug-approval measures by using substantial fees received from drug manufacturers when they submit a New Drug Application to acquire permission to market a new drug in the United States. Owing to the fees, which presently range from almost $600,000 to upwards of $1.1 million dollars, the FDA has been able to devote increased resources to drug-safety initiatives, such as monitoring pharmaceutical advertisements on television and improving its supervision of drug products.

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Although dietary supplements, including vitamins, are not considered prescription drugs by law, many proponents believe they can have similar positive health benefits. The FDA is authorized to oversee the safety of dietary supplements, as well, due to legislation called the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA).

Passed in 2006, the DSNDCPA is, like the PDMA, an amendment to the FFDCA. The law was established to help the FDA prevent adverse effects from unsafe usage of nonprescription drugs and dietary supplements by requiring accused manufacturers, packagers and distributors to file a report when an applicable adverse event occurs.

Benefits

Thanks to the prescription drug laws enacted by the federal government and state governments, the FDA has the required authority to purse a variety of offenses that could potentially endanger the health of individuals and even kill them. In addition, the money collected through the PDUFA offsets expenses and allows the agency to concentrate more effort on overseeing the development of new drugs, the advertising and promotion of existing drugs and the continued safety of drugs already on the market.

Resources

• U.S. Food and Drug Administration
• Laws Enforced by the FDA and Related Statutes