New Head of Global Compliance Seeks Increase of FDA Authority over Drug Imports and Recalls
Last month, the U.S. Food and Drug Administration (FDA) appointed a new deputy commissioner for global regulatory operations and policy, Deborah Autor. Autor, the former director of the Center for Drug Evaluation and Research (CDER) Office of Compliance, is urging Congress to increase the FDAs authority over imported drugs and the power to mandate recalls of unsafe drug products.
The FDA has recently announced the new “Pathway to Global Product Safety and Quality” in response to mounting problems related to the importation of food and medical devices; however, it does not cover the importation of drugs. See our previous report for more information on the FDAs new global strategy. Autor is seeking more effective regulation of imported drugs to create drug security in a global pharmaceutical economy.
In an effort to ensure that drugs and clinical trials from abroad adhere to standards comparable to those in the U.S., Autor proposed that the FDA have the power to stop imported drugs at the border if the manufacturer has refused FDA inspections. The FDA states 80 percent of the active ingredients in U.S. drugs are manufactured overseas. Additionally, it is estimated that drug imports will triple by 2015, while it is likely that FDA budget will not. The FDA also estimated that it would take nine years for the agency to inspect every high priority pharmaceutical facility just once. Autor claims that having the authority to stop potentially unsafe drugs at the border will prevent risks associated with uninspected products.
Autor has proposed FDA mandatory drug recall authority since the contaminated blood thinner, heparin, imported from China killed 81 people in 2008. Pursuant to the Food Safety Modernization Act (FSMA), the FDA has the authority to order mandatory recalls of food but not drugs. Advocates say that the Senate Committee on Health, Education, Labor and Pensions is likely to give the FDA stronger authority over drugs as part of a broader bill to renew FDA industry fees, which will expire next year.
Fuerst Ittleman will continue to monitor the FDAs progress regulating the importation of drugs. For more information, please contact us at contact@fidjlaw.com.