Leadership

Hospital Association Asks FDA to Help Tackle Drug Shortages

By / Nov 15, 2017 (fotografixx/Getty Images Plus)

In a letter to the FDA’s commissioner, the American Hospital Association drew attention to the large number of medications, especially those administered intravenously, that are facing shortages. Hurricane Maria has worsened the problem in recent weeks.

The American Hospital Association is raising some major concerns about its members’ access to common drugs.

Earlier this month, AHA reached out to the head of the Food and Drug Administration, expressing concerns that key medications, including many that are administered intravenously, were running short at many hospitals, which could prove a threat for patients.

A Business Insider piece notes that the issue is partly related to Hurricane Maria, which put facilities in Puerto Rico that make key medications out of commission. (Baxter, a key manufacturer of saline, was affected by the hurricane.)

But the hurricane isn’t the only reason. Shortages have increased in recent years, in part because some manufacturers stop making key drugs for business-related reasons, such as competition from cheaper imports, or because they were the only manufacturer of a specific generic drug.

In a letter to FDA Commissioner Scott Gottlieb [PDF], Thomas P. Nickels, AHA’s executive vice president of government relations and public policy, wrote:

We are concerned that the shortages of widely used and critical products are quickly becoming a crisis and looming threat to the public’s health. Therefore, we call on the FDA to both vigorously pursue strategies with the current manufacturers of these products and to seek out new suppliers in order to ameliorate the current shortage, as well as prevent such shortages from occurring in the future. More must be done to resolve the current shortages and secure the supply of these life-saving products moving forward.

Part of the challenge there is that it can be difficult for manufacturers to make the financials work with generic drugs. In his letter, Nickels suggests that the FDA could do more to help resolve this issue, including approving new domestic suppliers in areas “not prone to natural disasters.”

“We also appreciate your efforts to obtain alternative sources of the products, including from overseas suppliers,” Nickels adds. “However, we strongly urge FDA to do more by pushing current manufacturers to not only continue to produce these products at their maximum capacity but also to make investments to ensure an increasing supply for the future.”

An FDA spokeswoman told Business Insider that it was aware of the recent issues and working on a response to AHA’s concerns.

“The FDA understands the concerns and importance of the ongoing shortages of IV solutions, and we are actively working within our regulatory authority to address the shortage,” the spokeswoman told the website.

Ernie Smith

Ernie Smith is the social media journalist for Associations Now, a former newspaper guy, and a man who is dangerous when armed with a good pun. More »

Comments

Leave a Comment