FDA Authority Clarified

Victor C. Baum, M.D.; Daniel S. Orlovich, PharmD;Richard J Kelly, MD, JD, MPH

Letter to the Editor:

To the Editor:

The APSF Newsletter in February 2015 carried a piece on drug shortages (“Drug Shortages in the U.S. – A Balanced Perspective”). It seems there may have been an error. The authors indicate that the FDA “has no authority to regulate the quality of manufacturing." The statutory responsibility of the FDA in regulating manufacturing quality goes back many decades. Did the authors mean to write manufacturing quantity?

Sincerely, Victor C. Baum, M.D. U.S. FDA Siler Spring, MD Email: victor.baum@fda.hhs.gov

Dear Dr. Baum: We recognize and agree that the FDA has authority to regulate drug manufacturing quality. In our article, we referenced the ISPE’s definition of a "quality system" that, in part, is defined as a “system that complies with the regulations enforced by the FDA.” In addition, we list factors that may prevent drug shortages such as “Strong Quality Systems that lead to compliance with manufacturing regulations.” The FDA indeed has authority to regulate the quality of drugs manufactured and mandate reporting of drug shortages but, to date, has not been granted authority to regulate the quantity and hence the supply of drugs manufactured. We apologize for the typographical error.Daniel S

Orlovich, PharmD Richard J Kelly, MD, JD, MPH