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Regulatory Focus™ > News Articles > 2020 > 2 > Generic Firms Brace for Coronavirus-related Drug Shortages Next Summer

Generic Firms Brace for Coronavirus-related Drug Shortages Next Summer

Posted 26 February 2020 | By Zachary Brennan 

Generic Firms Brace for Coronavirus-related Drug Shortages Next Summer

As the US Food and Drug Administration (FDA) said yesterday that it’s tracking 20 drugs that could fall into shortage (no shortages have been reported yet), generic drugmakers are predicting shortages due to the coronavirus could occur as early as June or July.

The predictions come as the list of 20 drugs will remain confidential and as FDA is following up with generic firms regularly, according to comments detailed in a Bernstein investor note on Wednesday.

One unidentified generic company told Bernstein that FDA’s drug shortage office has sent inquiries on molecules with four or less manufacturers and asked companies about their ability to supply on each.

But he said he did not “get a sense of panic” from FDA and that the agency seems like it is betting on the ability of generic drug supplies to last for about six months. If China comes back online in the next two months it may blow over, he said, but if the outbreak and supply issues linger for longer without a solution, FDA may get worried.

Part of the problem for FDA is that although the number of active pharmaceutical ingredient (API) facilities is known in China (13% of the world’s total serving the US, by FDA’s numbers), Janet Woodcock explained last October that FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the U.S. market.”

Prices of some of the API and other raw materials are also beginning to increase, and patients may end up bearing the brunt of those increases.

So which drugs should consumers and others look out for? According to an op-ed last September by Reps. Anna Eshoo (D-CA) and Adam Schiff (D-CA), China produces the APIs found in almost every antibiotic and blood pressure medicine.

Rosemary Gibson, senior advisor at the Hastings Center and author of the book China Rx, told Focus that some of the generics that may fall into shortage include propofol, fentanyl, vancomycin, azithromycin, as well as some of the antihypertensives and anti-inflammatories.

According to Woodcock, FDA previously determined that there are three WHO Essential Medicines whose API manufacturers are based only in China: capreomycin and streptomycin, both indicated to treat tuberculosis; and the antibiotic sulfadiazine, used to treat the venereal infection chancroid and the bacterial eye infection trachoma.

Ciprofloxacin and doxycycline are two other drugs considered critical as medical countermeasures and used to treat anthrax and plague. FDA said the US has one facility for ciprofloxacin, versus three in China and 21 in other foreign countries. And the US has fewer facilities than China or other foreign countries for doxycycline.

Another generic firm told also Bernstein that although it has not seen any shortages yet, the two provinces where the infection is concentrated create exposure to eight of its finished products.

To help keep prices stable, generic drug manufacturer Sandoz said Wednesday that after conducting an internal assessment, it will not raise the prices of certain medicines if they may help in the treatment of coronavirus disease.

“The medications identified are priority antibiotics recommended in guidelines applicable for the management of Coronavirus Respiratory Infections: Amoxicillin oral and i.v, AmoxiClav oral and i.v., Piperacillin/Tazobactam i.v., Ceftriaxone, Clarithromycin oral and i.v., Levofloxacin aral and i.v., Meropenem, Vancomycin i.v., Gentamicin and Tigecycline,” a spokesperson said.

Certain Sandoz antivirals and hospital care products will also see their prices remain stable, including: Lopinavir/Ritonavir, Ribavarin, Oseltamivir, Atazanavir, Efavirenz, Ritonavir, Dolutegravir, Dobutamine, Ranitidine, Omeprazole i.v., Pantoprazole i.v., Heparin and Enoxaparin.

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