AHA: Senate plan on drug shortages is a step forward

AHA News
The AHA last week called a bipartisan Senate proposal for addressing prescription drug shortages as part of user fee legislation “a significant first step toward ensuring that patients have access to the medications they need.”

Developed by a bipartisan working group of 18 senators, the 14-page draft proposal would require most makers of life-saving drugs to notify the Food and Drug Administration (FDA) at least six months before discontinuances and interruptions that could lead to disruptions in U.S. supplies.

But the draft would provide several possible exceptions for companies to miss the time frame, such as economic hardship, supply issues or public health concerns.

The proposal would direct the FDA to expedite inspections and reviews of manufacturing sites or new products that could be helpful in addressing a drug shortage, and require the FDA to keep detailed records of previous drug shortages and the actions taken to prevent them.

It also would establish a task force to create a strategic plan to improve communication within the FDA and with public stakeholders, as well as report to Congress on price gouging and how pricing structures factor into drug shortages. The committee plans to mark up legislation by the end of this month.

In comments on the proposal, submitted to the Senate Health, Education, Labor and Pensions Committee, the AHA noted that “the number of drugs in critically short supply is increasing at an alarming rate and threatens quality of care in hospitals nationwide.”

The AHA said many of these drugs play a critical role in lifesaving treatments. “The potential harm to patient safety is of paramount concern,” the association added.

The AHA expressed support for many of the draft proposal’s key provisions, but said it could be “further improved to ensure that the true goal of eliminating generic drug shortages is accomplished.”

The AHA recommended Congress:

Institute civil monetary penalties or another enforcement mechanism to ensure compliance with the requirement for drug manufacturers to report production interruptions or product discontinuations; Include clinicians, patients and supply chain members in the task force created by the legislation to promote inter- and intraagency coordination, planning and decision making; Require the FDA to provide public notification about drug shortages, including adding the reason for the shortage and the anticipated duration, when possible; Require the FDA and Drug Enforcement Administration to collaborate, with appropriate flexibility where needed, to develop quotas for manufacturers producing controlled drugs;


Allocate more resources to the FDA to address drug shortages.

The AHA also expressed support for the proposal’s early notification requirement. But the association asked the working group to reconsider the exception for economic hardship, saying it does not believe “economic hardship suffered by a manufacturer outweighs the hardship of an untimely death due to a medication in short supply.” The AHA also supports the proposal’s inclusion of both biologics and biosimilar products.

The AHA’s recommendations are similar to those offered in an April 6 letter to the working group by the American Society of...
Topic: Advocacy and Public Policy

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