FDA Working to Mitigate Burden of Drug Shortages for Patients

In a statement from Commissioner Scott Gottlieb, MD, the US Food and Drug Administration (FDA) announced its commitment to reduce the stress experienced by patients as a result of unanticipated intravenous drug or supplies shortages.

According to an agency news release, only 2% of shortages result from product discontinuation. Other issues can precipitate a shortage, including an unforeseen clinical demand, a change in clinical practice guidelines, or FDA approval of a new indication for an existing drug.

“The FDA is focused on doing all we can to mitigate existing shortages and prevent them from occurring,” said Dr Gottlieb. “While we help avert and minimize shortages in many ways, the FDA can have the best impact by working more closely with sponsors to help prevent shortages before they occur.”

The 2012 FDA Safety and Innovation Act requires manufacturers to notify the agency of any disruptions, including “manufacturing changes, production or shipping delays, and product discontinuations likely to affect their supply of prescription drugs for serious illness.” However, the agency notes that sometimes advance notification is impossible because of circumstance.

One solution that the FDA offers is developing new technology to help improve manufacturing processes, reducing the chance that supply disruptions will occur. The FDA emerging technology team will oversee this initiative. Another answer is to work closely with Congress to reevaluate and potentially expand the FDA’s existing authority to “require applicants of certain drugs to conduct a risk assessment to identify the vulnerabilities in their drug supply…and establish risk mitigation plans.”

“Shortages are an inevitable consequence of an imperfect system. With better planning, we can minimize shortages throughout the supply chain,” Dr Gottlieb concluded. “We must all work together to ensure that the supply chain infrastructure can withstand inevitable and unexpected disruptions.”

Reference

Statement from FDA Commissioner Scott Gottlieb, MD, on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities [news release]. Silver Springs, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609453.htm. Published May 31, 2018. Accessed May 31, 2018.