Balance needed
Parallel to the shortage crisis, FDA has been campaigning for more authority to control counterfeiters and manage an increasingly
global pharma supply chain. A number of bills before Congress would empower FDA to deal more forcefully with illegal imports
and to address drug manufacturing problems. The challenge is to ensure that efforts to strengthen FDA clout does not aggravate
drug shortages.
At a hearing Sept. 14, before the Senate Health, Education, Labor, and Pensions (HELP) Committee, Deborah Autor, recently
named FDA deputy commissioner for global regulatory operations and policy, presented a long list of desired policy changes
to promote drug safety and level the playing field between domestic and foreign manufacturers. Autor wants mandatory recall
authority for drugs, power to detain and destroy violative imports at the border, and much stiffer penalties for noncompliance.
Drug manufacturers and importers would have to register and list manufacturing facilities using identifier numbers, and importers
would have to demonstrate that they meet quality standards, instead of FDA proving that they do not. Autor also seeks more
authority to enforce track-and-trace standards, which would help hospitals and physicians know whether drugs from unknown
or unusual sources are legitimate.
Industry supports many of these changes, but is wary that continued shortages will spur calls for even greater government
intervention in the market. The danger is that added rules could make low-profit drug markets less attractive to manufacturers.
Yet, patients are waiting: Short supplies of drugs to treat children with leukemia in the US is "shameful," lamented oncologist
Len Lichtenfield at the FDA workshop. "Maybe we need more government intervention."
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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