Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"

The COVID-19 pandemic brought to light the fragility of the pharmaceutical supply chain and demonstrated that disruptions can lead to drug shortages. We have written extensively about the government’s response to shortages during the pandemic and the actions taken to ameliorate the problem. One such measure is the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in March 2020. The CARES Act is intended to provide relief in response to the COVID19 pandemic. This Act modified the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created certain provisions imposing new obligations on some manufacturers which prompted the United States Food and Drug Administration (FDA) to release a 21-page draft guidance document in May 2022 titled, “Risk Management Plans to Mitigate the Potential for Drug Shortages.” The comment period for this draft guidance recently closed July 19, 2022, and companies affected by section 506C(j) of the FD&C Act should review the guidance.

This guidance applies to drug manufacturers and those manufacturing active pharmaceutical ingredients (API). It sets out the requirements for the creation of risk management plans (RMPs) for certain products. Because implementing compliant RMPs is a potentially resource-intensive effort requiring specialized expertise, companies should become familiar with the guidance as soon as possible. Per the guidance document, RMPs are required for the following products:

1. prescription drug products that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition;
2. any drug that is critical to the public health during a public health emergency declared by the Secretary under section 319 of the Public Health Service Act;
3. any API included in the prescription drug products described above;
4. any associated medical device used for preparation or administration included with the prescription drug products described above.

The document continues with a long list of products for which RMPs are recommended but not required.

The FDA defined primary, secondary, and other stakeholders within the draft guidance to aid manufacturers in understanding their potential obligations to each. Note that the term “other stakeholders” is defined broadly and implicates a large variety of drug and API manufactures. Further, each individual drug or active ingredient requires its own individual RMP.

Our insureds are encouraged to engage with legal counsel early to ensure they remain compliant. Failure to comply with the RMP requirements will result in a noncompliance letter.