An ongoing drug shortage in the U.S., caused by fewer manufacturers making cheaper generic drugs and an overly complicated global supply chain, could leave patients scrambling for lifesaving medications for months or possibly years to come.
in late June. Unlike brand-name drug companies, he said, generic drugmakers are not protected by patents that allow them to exclusively sell medications for a set period of time. In order for generic drug manufacturing to grow in the U.S., companies need to be paid enough to manufacture the drugs and stay in business.The problems facing the industry now are likely to get worse as more U.S. companies go under.
“If you talk to someone in the generic drug industry, they’ll tell you that about a third make money, a third break even and a third lose money,” he said.The U.S. is already highly dependent on foreign drugmakers. In 2021, 78% of the suppliers of active pharmaceutical ingredients were in China, India and the European Union, according to the FDA. With Akorn’s closure, the U.S. will be even more dependent on overseas manufacturing.
Foreign suppliers don’t always meet the rigorous FDA standards for generic drugs. What’s more, FDA visits to foreign facilities are often notified in advance and the investigatorsto provide translation services — raising concerns about whether the agency is getting all the information it needs to accurately assess the quality of the products.
“Overseas production in China and India has edged out all but a few manufacturing plants in North America,” said David Gortler, a former science policy adviser at the FDA and an FDA oversight expert. “Unfortunately, lower prices are usually accompanied by poor quality.” In December, Intas Pharmaceuticals, a generic drug manufacturer based in India, temporarily suspended production after an
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