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FDA Moves to Soothe Fears of Drug Shortages After Tornado Hits Pfizer Plant

The Food and Drug Administration is moving to soothe worries that Wednesday’s tornado strike on a
Pfizer
plant in North Carolina could lead to widespread drug shortages, saying that that there are enough supplies currently on hand at hospitals and in the distribution system to forestall a crisis.

The FDA also said the plant only supplies 8% of sterile injectables to U.S. hospitals, correcting widespread early reports that it supplied 25% of the market. The agency also said that the plant is the sole source of only a handful of drugs.

“We do not expect there to be any immediate significant impacts on supply,” the agency’s director, Dr. Robert Califf, said in a statement late Friday afternoon.

Pfizer
(ticker: PFE), meanwhile, said Friday that the facility’s warehouse suffered most of the damage, and that there did not appear to be major damage to the areas of the plant where the medicines were produced. The company said that all of the site’s 3,200 employees were safe and accounted for. It did not offer a timeline for when production at the plant might restart, but said it is “committed to rapidly restoring full function to the site.”

Pfizer also said it was looking for alternative manufacturing locations, at Pfizer facilities and elsewhere.

Shortages of sterile injectable medicines, used widely in hospitals, have been a growing issue in the U.S. in recent years, and reports that Pfizer’s manufacturing facility in Rocky Mount, North Carolina, had suffered significant tornado damage on Wednesday raised fears of a crisis. The Rocky Mount plant, which Pfizer bought as part of a 2015 acquisition, is one of the largest sterile injectable manufacturing facilities in the world.

The plant makes nearly a quarter of Pfizer’s sterile injectibles. The FDA said that it believed that the plant is the sole source of “less than 10” drugs, and that “many weeks’ worth of stock” should be available for those drugs. Some of those drugs could be substituted with others, the FDA said.

The agency said that it has “initiated mitigation steps” for drugs made at the facility that had been in shortage before the tornado hit, or which are at risk of shortage.

Pfizer said that the destroyed warehouse contained raw materials for medicines, among other things. It said it is looking to replace the damaged raw materials.

The tornado strike had set off a surge in the share prices of Pfizer’s competitors in the sterile injectables market, but that surge abated Friday. The American Depository Receipt of
Hikma Pharmaceuticals
(HKMPY), which closed at $50.30 on Wednesday, rose 5.4% on Thursday before falling 4.8% on Friday to close at $50.50.

Pfizer shares climbed 0.9% on Thursday and 1.7% on Friday.

Images of the Rocky Mount facility showed extensive damage. The tornado tore to shreds the roof and sides of what appeared to be the warehouse building, and overturned at least a half dozen trailers. Underneath the mangled roof was what appeared to be a chaotic jumble of twisted racks and pallets.

The tornado was rated an EF-3 using the measure known as the Enhanced Fujita Scale, with estimated peak winds of 150 miles per hour. It was the first EF-3 tornado ever to hit central North Carolina in July, according to the National Weather Service.

Write to Josh Nathan-Kazis at [email protected]



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