GAO Report Supports Senate Compounding Bill

The report says FDA's authority to oversee drug compounding is "unclear," and two federal circuit court decisions resulted in differing authority in different parts of the country.

A new report from the Government Accountability Office (GAO) backs up congressional testimony by two top officials at the U.S. Food and Drug Administration about the challenges FDA inspectors face when trying to oversee the compounding pharmacy industry. The report, titled "Clear Authority and More Reliable Data Need to Strengthen FDA Oversight," points out that two federal circuit court decisions resulted in differing authority in different parts of the country.

The FDA officials -- Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, and Dr. Margaret Hamburg, commissioner of Food and Drugs, testified before U.S. House of Representatives committees in November 2012, April 2013, May 2013, and July 2013 as Congress considered possible legislative responses to the fungal meningitis outbreak associated with the New England Compounding Center. Both said their agency’s inspection authority is limited, and the GAO report agrees.

From 2002 through 2012, FDA officials had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged its inspection authority, according to the report, which says GAO "also found that while FDA and national pharmacy organization officials generally agreed that states regulate the practice of pharmacy and FDA regulates drug manufacturing, there was no consensus on whether compounding drugs in large quantities--in anticipation of individual prescriptions or without prescriptions--and selling those drugs across state lines falls within the practice of pharmacy or is a type of drug manufacturing that should be overseen by FDA. This lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding."

The report supports the need for Congress to pass S. 959, The Pharmaceutical Quality, Security, and Accountability Act, which was introduced by the leaders of the U.S. Senate Health, Education, Labor and Pensions Committee: Chairman Tom Harkin, D-Iowa, and Ranking Member Lamar Alexander, R–Tenn., with support from other HELP members. The committee unanimously passed it in May, and HELP leaders are urging their colleagues to get it passed in the full Senate as soon as possible.

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