President Obama has issued an executive order that directs Food and Drug Administration (FDA) to take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines. Stressing that “shortages of pharmaceutical drugs pose a serious and growing threat to public health,” and that the number of prescription drug shortages in the United States nearly tripled between 2005 and 2010, the executive order directs FDA to:
- require manufacturers to provide adequate advance notice of manufacturing discontinuances that could lead to shortages of drugs that are life supporting or life sustaining, or that prevent debilitating disease;
- expand current efforts to expedite regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever the agency determines that expedited review would help to avoid or mitigate existing or potential drug shortages; and
- communicate to the Department of Justice (DOJ) any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ will determine whether such activities are consistent with applicable law, and take action as appropriate.
As noted in an October 31, 2011 White House blog post, “the Executive Order is only one in a series of steps that will help address the prescription drug shortages our nation faces. The Obama Administration sent a letter to drug manufacturers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA and encourages companies to voluntarily disclose to FDA potential shortages in cases where disclosure is not currently required by law.” In addition, staffing resources for FDA’s Drug Shortages Program will be increased, and two reports addressing the issue of drug shortages have been released:
- “ASPE Issue Brief: Economic Analysis of the Causes of Drug Shortages,” from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation.
- “A Review of FDA’s Approach to Medical Product Shortages,” from FDA.
Additional information is available in a fact sheet on the White House Web site, and on the “Drug Shortages” page of the FDA Web site.