A federal task force proposes regulatory solutions to mitigate drug shortages.
Drug shortages in the United States routinely force doctors to ration medicine. The current shortage of vincristine—a drug essential for treating most childhood cancers—has left doctors struggling to decide who gets the medicine, and how much they get.
Some observers have hinted that a pharmaceutical company may be partly to blame for the vincristine shortage, given the company’s recent decision to stop making the drug. But these accounts belie the complexity of the problem, especially since the company in question reports having made only 3 percent of the overall vincristine supply, with another company producing the other 97 percent. Even if continued production had mitigated the shortage, the fact that over 100 drugs are currently in short supply in the United States suggests the need for solutions beyond some redundancy in manufacturing.
In a new report, an interagency task force chaired by the U.S. Food and Drug Administration (FDA) explores the underlying causes of drug shortages—defined as a period of time in which the demand or projected demand for any medicine exceeds the supply—and recommends measures to prevent and mitigate future shortages.
According to the report, the underlying causes of drug shortages in the United States include a lack of economic incentives to make certain drugs and develop mature quality management systems, as well as regulatory challenges that inhibit recovery from manufacturing disruptions.
In the report, FDA recommends several regulatory solutions to the problem of drug shortages, some of which the agency is already implementing.
First, FDA is seeking expanded authority to penalize manufacturers that fail to provide the agency with timely notifications about drug shortages. Increased penalties would presumably motivate manufacturers to comply with existing regulations so that FDA can respond to actual and potential shortages more quickly.
Second, FDA plans to publish guidance that will further explain the reporting requirements for anticipated disruptions in production, including any decisions to stop making a given drug. Although this guidance would not be legally enforceable, clarifying the existing reporting requirements may improve the quality of information that FDA receives so that the agency may react in a timely fashion.
Third, FDA is seeking increased legislative authority to require manufacturers to research and then label drugs with the latest possible expiration date when needed to prevent or mitigate a drug shortage. If enacted, this change would mitigate shortages by reducing the number of drugs that are discarded based on overly cautious expiration dates.
FDA already has authority to test and then extend the recognized shelf life of drugs that the government keeps for public health emergencies, but new legislation would put the burden of testing shelf life on the manufacturers. Although FDA characterizes weak economic incentives to make certain drugs as a key underlying cause of drug shortages, the report does not address whether new research and labeling requirements would weaken incentives even more.
In addition to these proposals, which appear to be reactive in nature to the problem of drug shortages, FDA also outlines some initiatives that respond directly to the purported root causes.
First, FDA has identified a need for new legislation that would increase the agency’s power to require manufacturers to assess supply chain vulnerabilities for drugs deemed to be at increased risk of shortage. If such legislation is passed, FDA would then require manufacturers to develop risk management plans to mitigate known vulnerabilities with the aim of fewer disruptions in production. This initiative, if successful, will drive manufacturers toward mature quality management systems instead of permitting them to scrape by on the current regulatory requirements, which are largely relegated to assuring product safety and consistency between batches.
In anticipation of this legislation, FDA has apparently begun developing draft guidance that outlines recommendations for the creation, maintenance, and use of risk management plans.
Second, FDA reports that it will soon publish new guidelines to facilitate modernization in manufacturing equipment and processes. This effort is part of an international deregulatory initiative to encourage innovation in drug manufacturing. The new guidelines will presumably aim to reduce costly reporting requirements for post-approval changes to manufacturing facilities and methods so that the private sector can afford to innovate and may respond more facilely to disruptions in production. In turn, innovation may lead to greater reliability in manufacturing so that there are fewer and less severe drug shortages in the future.
In recognition of the complexity of the problem, FDA also enlists the help of other agencies and the private sector to combat drug shortages. In particular, FDA recommends increasing transparency in contracting practices, developing a rating system for manufacturing facilities, and conducting additional research into the prevalence and effects of drug shortages.
The task force that authored the report was convened in response to a bipartisan call to action in the 115th Congress. The report relies on internal research within FDA, as well as feedback obtained through public comments, invitation-only listening sessions, and a public meeting where then-FDA Commissioner Scott Gottlieb remarked that drug shortages “present an immediate and serious risk for patients” and “threaten the stability of our health care system.”
In light of recent trends toward longer and more frequent drug shortages, it is past time for renewed efforts to ensure an adequate supply of medicine in the United States.
