Bioethics Blogs

The FDA Should Have No Role in Setting Prices for Off-Patent Pharmaceuticals

An article that appeared in the Journal of the American Medical Association
on January 4, 2016, written by Johns Hopkins Institute of the History of
Medicine and Bloomberg School of Public Health professors Jeremy A. Green,
Gerard Anderson, and Joshua M. Sharfstein recommended that the Food and Drug
Administration (FDA) act to improve access to approved generic drugs that are
becoming scarce because of a lack of competition. It’s surprising that respected historians and health policy educators believe
that the FDA should have any such governmental role. As highly regarded as they
are, the authors appear neither to fully understand FDA and drug regulation
history or health care delivery competition oversight. The FDA has never had
statutory authority to regulate drug prices, period. And, they rightly
shouldn’t have.

The
FDA exists to protect the public safety, health, and welfare by assuring that
drugs marketed in the US are safe and effective. The reasonableness of the
prices for these drug products is of no concern to the FDA as a regulatory
body. In the general scheme of federal oversight, fair business and trade
practices are the responsibility of the Federal Trade Commission (FTC) and the
Civil and Criminal Divisions of the Department of Justice. These governmental
authorities are responsible for the enforcement of the anti-competition and
antitrust laws. The FDA has enough to do already; drug pricing should be left
in the regulatory hands that are charged with this duty without involving the
FDA. There’s no real value of involving the FDA here, except perhaps to muddle
the waters more.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.