Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA, took steps to address the problem. Progress has been made, and Congress is further evaluating if additional steps need to be taken.
Late last month, the Senate Health, Education, Labor and Pensions (HELP) Committee approved the Food and Drug Administration Safety and Innovation Act. The bill, which now goes to the full Senate for approval, reauthorizes the FDA user-fee program and also contains measures to strengthen ways to deal with drug shortages. The bill proposes revising the timing of advance notifications of possible shortages, requiring a strategic plan on shortages, broadening the definition of what constitutes a meaningful disruption of drug supplies, and creating a process for physicians and others to report evidence of shortages, as outlined by the American Medical Association (AMA) in analyzing the bill. Industry groups, such as AMA and the American Society for Health-System Pharmacists, support these measures.
In a blog and in testimony before the Subcommittee on Health of the House Committee on Energy and Commerce, which also is considering measures to address drug shortages, FDA Commissoner Margaret Hamburg outlined the progress made in reducing drug shortages. Last October, President Barack Obama issued an Executive Order that directed FDA and the Department of Justice to take action to reduce and prevent drug shortages. Since the issuance of the Executive Order, FDA has successfully prevented 118 drug shortages and reduced the number of drug shortages. According to Hamburg’s blog, 42 new drugs in shortage have occurred in 2012 thus far compared to 90 new drugs in shortage in a comparable time period last year.
In her testimony, Hamburg outlined FDA efforts. When it learns of a potential shortage situation, the agency works directly with the affected manufacturer in several ways: developing temporary workaround solutions to manufacturing or quality issues; consulting with the manufacturer to resolve the underlying problem; or helping the manufacturer find additional sources of raw materials. It also expedites the review of submissions by the manufacturer that may alleviate the drug shortage while continuing to meet safety standards, which may include requests to extend the expiration date of products, make manufacturing changes to increase capacity, use a new raw material source, or change product specifications. FDA can also use its regulatory discretion for a manufacturer to continue marketing a medically necessary drug if the manufacturer can develop a method to resolve a quality issue prior to the drug’s administration. In addition to working with the affected manufacturer, FDA also does the following: works with third parties to determine whether they can help avoid or minimize the shortage; expedite reviews of generic applications for products facing potential shortages; and in certain situations, when a shortage cannot be resolved immediately, FDA can use its regulatory discretion for the temporary import of non-FDA-approved versions of critical drugs after ensuring there are no significant safety or efficacy risks for US patients.
These measures have had impact, but a question is whether more systematic means should be in play. Some commentary on this subject have suggested national stockpiles, such as those used for vaccines, be used to avert shortages. Whether this is an appropriate solution is unclear. What is clear, however, is that strengthening regulatory oversight to prevent or reduce drug shortages is an important goal for industry and consumers alike.