As the amoxicillin shortage drags on, several senators pressure FDA and HHS for solutions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

The letter says, in part:

We urge the Department of Health and Human Services and the Food and Drug Administration (FDA) to convene the Drug Shortage Task Force and work with stakeholders, including providers, on identifying factors and potential solutions to mitigating the amoxicillin shortage. Further, we request an update on FDA initiatives to prevent and mitigate drug shortages.

The letter noted that amoxicillin, often used to treat pediatric illnesses, is in short supply due to a “record high level of respiratory illnesses” that spiked demand for it and other medicines, leading to delays in care.

Erin Fox

Erin Fox, the senior pharmacy director at the University of Utah Health, noted that while senators such as Klobuchar have been vocal about drug shortages for years, the situation is not cut and dried.

“FDA can’t make any drug company make any drug no matter how critical or life-saving. This is really up to the generic drug makers to make these products. Most of the companies refuse to provide a real reason for what is going on – and they don’t have to do so publicly,” Fox told Endpoints News via email.

Fox noted that the FDA’s drug shortage task force has outlined solutions. However, none of them have been implemented yet.

Michael Ganio

Michael Ganio, the senior director of pharmacy practice and quality at the American Society of Health System Pharmacists (ASHP), said that while it is a good thing to see members of congress devoting attention to drug shortages because shortages can have a detrimental effect, it’s not just amoxicillin in short supply.

“Amoxicillin is one of more than 260 drugs currently in short supply, so it is imperative that we implement some critical measures to shore up the resilience of our national drug supply chain to ensure that patients are able to get the medication therapy they need,” Ganio said.

For the current situation on amoxicillin, Ganio said that the shortage will likely last until at least early 2023 and will depend on the duration and scope of the outbreak of “pediatric respiratory infections.” He also noted that ASHP is noticing reported shortages of amoxicillin alternatives such as amoxicillin/clavulanate.

One of the producers of the drug, Sandoz, told Endpoints in late October that factors including manufacturing capacity, scarcity of raw materials and the energy crisis, among others, are affecting production, but the company added it is “on track” to bolster its supply and is trying several ways to boost its manufacturing capacity.

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