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Regulatory Focus™ > News Articles > 2019 > 1 > AHA Offers FDA Recommendations to Mitigate Drug Shortages

AHA Offers FDA Recommendations to Mitigate Drug Shortages

Posted 14 January 2019 | By Ana Mulero 

AHA Offers FDA Recommendations to Mitigate Drug Shortages

The American Hospital Association (AHA) last week offered legislative and regulatory recommendations to address the “daunting challenge” of drug shortages in a comment to the US Food and Drug Administration (FDA).

The move comes as a response to FDA’s request for input ahead of the November 2018 public meeting that the agency held for participants to discuss systemic causes and make recommendations to prevent or mitigate drug shortages. The public comment period closed last Friday, with about 70 submissions.

AHA identified six legislative and nine regulatory recommendations for FDA to consider, building off experience with drug shortages from the perspective of US hospitals and health systems.

The legislative recommendations call for expanding current shortage reporting requirements for manufacturers, creating new incentives for manufacturers to establish contingency plans and/or redundant production lines, as well as requiring that manufacturers disclose production locations to FDA and that federal agencies assess whether a drug shortage might present a threat to national security.

The Federal Trade Commission should include the potential risk for a drug shortage when conducting reviews of proposed mergers and acquisitions among drug companies and Congress should “enact legislation that requires medical device manufacturers to notify FDA in the event of an interruption or discontinuation for certain medical devices and equipment needed to administer drugs,” AHA argued.

From creating incentives for manufacturers to produce drugs that are in short supply to preventing manufacturing facilities from closing down, the regulatory recommendations are wide-ranging.

“FDA should improve the process for enforcing the current good manufacturing practices (cGMP) regulations by shortening turnaround times and improving and standardizing processes of FDA reviews to identify problems prior to shutting down facilities,” the association argued. “Further, a more rapid review of corrective actions taken by manufacturers could help reduce the duration of supply interruptions.”

Other regulatory recommendations relate to establishing a new rating system to promote quality manufacturing, making more cGMP information publicly available and removing FDA Form 483s in a timely manner once observed nonconformities are resolved, incorporating the American Society of Health-System Pharmacists’ list into FDA’s list of drug shortages, developing a list of critical drugs, reducing drug waste and creating a clinical affairs office within the Drug Enforcement Administration.

AHA also called on the agency to consider how the FDA approval process might help mitigate or exacerbate existing drug shortages in the US. “FDA has been assisting drug manufacturers with finding opportunities to legally market older ‘grandfathered’ products that are currently marketed without the required FDA approval,” AHA noted. “There have been concerns that these efforts to bring widely used but unapproved drugs into compliance with current FDA requirements have resulted in drug shortages.”

The association identified four market recommendations for industry best practices as well. These include encouraging early and ongoing multi-stakeholder interactions, updating drug shortage remediation plans on an annual basis and focusing on widely used and critical drugs, among others.

Drug shortages came under the spotlight recently partly due to the lack of IV saline products in Puerto Rican hospitals after the devastation caused by Hurricane Maria. Data show a spike in the number of drug shortages over the past year versus the early 2000s. A new drug shortages task force in 2018 and expanding on temporary imports of certain drugs from foreign facilities are among FDA’s recent efforts in the area. 

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