FDA Withdraws Proposed Rule for Drug Labels

Pharmacy TimesFebruary 2019 Heart Health
Volume 85
Issue 2

Agency hands industry a win after concerns arise that manufacturers could be exposed to liability.

FDA officials said in December 2018 that they will withdraw a 2013 proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, that would have made the same procedure for updating labels that applies to brand name drugs apply to generics.1

If the rule had been carried out, generic drug manufacturers would have had to update safety information on their drug labels as health risks were discovered, as is the case for brand name drugs. Currently, generic drug makers do not update their labels unless ordered to do so by the FDA.

When the rule was first proposed 6 years ago, it sparked a debate about generic drug labels, and the FDA received even more comments on the proposal at a public meeting on the subject in 2015. Generic drug makers opposed the proposed rule, saying that it would increase the burdens and potential liability on the industry, driving up generic drug prices. The industry also contended that the proposed rule could have resulted in different labels on the same generic drugs produced by different manufacturers, leading to confusion among patients.

FDA officials recognize that choosing a drug for treatment can be difficult, with drug cost playing a huge role in the decision, the agency said in a statement. These officials consider patient accessibility to quality low-cost generic drugs when creating drug label guidelines, it said.

These considerations led the FDA to evaluate the process for updating generic drug labels and propose the rule, according to the statement. But after considering the public comments and industry feedback, the FDA decided that withdrawing the proposed rule was in the public’s best interest.

However, the FDA did say that some generic drug labels need updates and that the agency will launch a program to update labels on certain generic cancer drugs with the most recent information on efficacy and safety to ensure that patients and providers can make the appropriate treatment decisions.

Organizations, such as the Association for Accessible Medicines (AAM), expressed their support of the FDA’s decision to withdraw the proposed rule.

“AAM applauds FDA Commissioner Scott Gottlieb and the agency for prioritizing consumer access to safe, high-quality, affordable generic medicines by withdrawing its proposed labeling rule. The agency correctly recognized the need for consistency and the potential for adverse consequences,” David Gough, senior vice president of science and regulatory affairs at AAM, said in a statement.2 “The FDA’s action further exemplifies its focus on the best interest of the public’s health and provides patients with the utmost confidence in their health care choice.”


  • Statement from FDA Commissioner Scott Gottlieb, M.D. and director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development [news release]. Silver Spring, MD: FDA; December 13, 2018. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628339.htm. Accessed January 22, 2019.
  • AAM statement on FDA withdrawal of generic drug labeling rule [news release]. Washington DC: Association for Accessible Medicines; December 13, 2018 accessiblemeds.org/resources/press-releases/aam-statement-fda-withdrawal-generic-drug-labeling-rule. Accessed January 22, 2018

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