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FDA Relaxes Rules to Make Muscle Relaxers, Drugs for Covid-19

April 16, 2020, 7:09 PM

Hospitals will have more options to buy drugs used to treat Covid-19 patients—like muscle relaxers and painkillers—thanks to relaxed rules the FDA announced Thursday to address drug shortages across the country.

The changes mean facilities that produce drugs and sell them to hospitals don’t have to stick to a strict ingredient list established by the FDA when making large batches of drugs for hospitals to treat Covid-19 patients.

They are also freed from some manufacturing steps that would otherwise be typically required, such as running tests to determine expiration dates or abiding by certain packaging restrictions.

The rules apply to drugs used to treat Covid-19 that are listed by the FDA as being in short supply, including muscle relaxers, an antibiotic, an anxiety medication, and a few different types of painkillers. The agency said other drugs could be added to the temporary policy change later.

The changes are meant to increase the flow of life-saving drugs to hospitals inundated with patients sickened by Covid-19, the disease caused by the coronavirus. There aren’t any approved treatments as yet, so doctors must treat symptoms with whatever resources are on hand.

Critically ill patients sometimes need to be put on ventilators, which requires them to have a breathing tube inserted down their throat. Doctors need muscle relaxers to make that process go smoothly but have run into shortages around the U.S. as demand for muscle relaxers has risen and the pandemic has put a wrench in the nation’s already fragile drug supply chain.

The FDA has leaned heavily on the pharmacy community and facilities that produce small batches of drugs throughout the emergency. In mid-March, for instance, the agency began encouraging pharmacists to make hand sanitizer in their own labs as stores sold out their stocks. Two more policies encouraging hand sanitizer production have come out since then.

A couple of weeks later, FDA Commissioner Stephen Hahn gave the green-light for more pharmacists and drug facilities to make their own batches of hydroxychloroquine, the malaria drug President Donald Trump has touted as a promising treatment for Covid-19, causing demand to skyrocket, despite a lack of conclusive evidence that hydroxychloroquine works on the virus. The drug has been added to the FDA’s drug shortage list.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Melissa B. Robinson at mrobinson@bloomberglaw.com Fawn Johnson at fjohnson@bloomberglaw.com

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