The Food and Drug Administration (FDA) has urged drug manufacturers to address ongoing drug supply chain issues.
The FDA’s intervention efforts have helped address drug shortages in the past, according to the agency, but “disruptions in the U.S. drug supply continue to occur due to drug quality problems, vulnerabilities in the global supply chain, unanticipated increases in demand, market withdrawals of drugs or natural disasters,” the FDA said.
Drug shortages have been impacted by COVID-19, with 95% of doctors believing the pandemic exposed weaknesses in the medicine supply chain. The first drug shortage resulting from the pandemic was reported by the FDA in March 2020, though the agency didn’t state which drug was experiencing a shortage at the time. The Department of Health and Human Services (HHS) teamed up with Civica Rx in 2020 to produce essential generic medicines and their ingredients to mitigate shortages.
The FDA released a report in 2019 that called for adoption of risk management plans to proactively prevent supply chain disruptions that could lead to drug shortages. In 2020, Congress passed the CARES Act, which required drugmakers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply. The FDA has now released guidance to help drugmakers meet these requirements.
The draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, offers a framework for stakeholders when considering their risk management plans. The framework identifies risk factors and aligns with principles stated in the International Council for Harmonisation guidance for industry, known as Q9 Quality Risk Management.
“Today’s draft guidance is an important step in what the nation needs to achieve an increasingly secure and resilient drug supply,” the FDA noted May 19. “For Americans to have access to an uninterrupted supply of safe, effective and high-quality drugs, all entities involved in the manufacture of a drug should take every step available to reduce risks and threats to the drug supply chain. Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.”
See the FDA’s guidance content here.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."