Regulatory Focus™ > News Articles > GAO: FDA Enforcement of Up-To-Date Information on Antibiotic Drug Labels Lacking

GAO: FDA Enforcement of Up-To-Date Information on Antibiotic Drug Labels Lacking

Posted 01 February 2012 | By Alexander Gaffney, RAC 

An investigation by the US Government Accountability Office (GAO) has found that the US Food and Drug Administration (FDA) "has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints."

Breakpoints are the "concentrations at which bacteria are categorized as susceptible to an antibiotic," and are used to ensure that adequate doses are administered. Inadequate doses of an antibiotic can lead to increased rates of antibiotic-resistant strains of bacteria.

GAO's report analyzed the impact of the FDA Amendments Act of 2007 (FDAAA) on FDA, which requires FDA to identify and update breakpoints for antibiotics. Specifically, GAO looked at whether or not FDA was ensuring that labels on antibiotics were up-to-date and what impact FDAA's provisions are having.

GAO found that FDA "has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints," particularly for generic antibiotics referencing an Orange Book listed innovative drugs.

Despite contacting the 210 sponsors of antibiotic products in 2008, FDA only heard back from 146 of those sponsors by 2011-a response rate of just 70% over a 3.5 year period. Of those responses received, GAO noted that FDA regularly took more than one year to complete review of the response. FDA attributed this lag time to a lack of resources paired with the scientific challenges of reviewing and gathering data.

GAO recommended that "the Commissioner of FDA take steps to help ensure antibiotic labels contain up-to-date information, such as by expediting the agency's review of breakpoint submissions."



Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe