In response to the increase in drug shortages over the past three years, President Obama issued an executive order on Oct. 31, 2011 that directs FDA to take the following steps to prevent and reduce drug shortages:
- Require manufacturers to provide advance notice of manufacturing discontinuities that are likely to lead to shortages.
- Provide expedited regulatory review of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages.
- Report to the Department of Justice any suspected stockpiling of drugs or the sale of drugs in short supply at exorbitant prices by distributors.
FDA sees the requirement for advance notice as crucial to managing shortages, and such notice has been instrumental in averting at least 99 drug shortages, according to the agency. Many drugs in short supply are generics, and the Generic Pharmaceutical Association issued a press release affirming its commitment to working with FDA to alleviate the problem. “Generic manufacturers have pledged to work with the FDA and healthcare providers to formalize the process for not only manufacturers, but also others in the supply chain, to proactively report drug shortages to the FDA’s drug shortage staff, as many now do voluntarily,” according to the press release.
The Pharmaceutical Research and Manufacturers of America also issued a release in support of the executive order, stating “America’s innovative biopharmaceutical companies have long worked to prevent drug shortages in advance, and will continue to work closely with the FDA to prevent manufacturing disruptions.” The organization also stated, “While the majority of drug shortages involve generic drugs, with FDA specifically referring to an increase in shortages among ‘older sterile injectable drugs,’ this problem concerns us all and requires our combined attention.”
According to a White House press release, the executive order is one in a series of steps that will help address the shortage of prescription drugs and ensure patients have access to the medicines they need. The Obama Administration also took the following steps:
- Sent a letter to drug manufacturers, reminding them of their legal responsibility to report the discontinuation of certain drugs to FDA. The letter also encourages companies to voluntarily notify FDA about potential prescription-drug shortages when notification is not currently required.
- Increased staffing resources for FDA's Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.
- Released a report from the Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) that assesses the underlying factors that lead to drug shortages. The administration also released an FDA report on the agency’s role in monitoring, preventing, and responding to these shortages.