Final rule adds manufacturing delay reporting requirements

By Nick Taylor

- Last updated on GMT

Related tags: Government accountability office, Barack obama

Final rule adds manufacturing delay reporting requirements
Manufacturers of certain critical drugs must report production interruptions to the FDA under a new interim final rule.

The interim final rule will make firms that are the only producers of certain critical drugs report all manufacturing interruptions to the US Food and Drug Administration (FDA). The move comes as a US Government Accountability Office (GAO) speaker called for more FDA powers at a US Senate hearing.

FDA is constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages​”, Marcia Crosse, director, health care at GAO, said.

The day Crosse spoke to a US Senate hearing into drug shortages the interim final rule was released. Companies that are the sole suppliers of drugs that are “life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition​” must now report all interruptions.

Crosse said this wording covers “a narrow set of drugs​” and called for greater FDA powers. Proposed legislation could help. The Preserving Access to Life-Saving Medications Act​, which President Obama supports, would make manufacturers report all drug shortages to the FDA.

Generic action

At the US Senate hearing the Generic Pharmaceutical Association (GPhA) detailed its plan to tackle drug shortages. The Accelerated Recovery Initiative (ARI) will gather current and future supply data for critical products.

This will then be used to determine current and potential supply gaps, with a focus on those products where a shortage is expected to last longer than 90 days​”, Ralph Neas, president and CEO of GPhA told the US Senate hearing.

However, some think more capacity is the only true solution. “The current shortages will likely be resolved when new supply sources come online as the manufacturing industry increases its capacity​”, Sherry Glied, assistant secretary at the US Department of Health and Human Services, said.

Related topics: Processing, QA/QC

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