Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said Sunday that drug price caps set by the Control Inflation Act are exacerbating drug shortages.
Gottlieb, now a board member of Pfizer, told CBS’s “Face the Nation” that “actions under the Inflation Act will make this problem even worse because these generic drug makers will respond to price increases. Because it won’t work,” he said.
“For example, if you are entering a market for the first time, or if you spend a lot of money upgrading your facility to comply with state-of-the-art regulations, you cannot afford a price increase. We can retrieve it,” he added. “So it will come out of their own pocket.”
Gottlieb said sterile injectable drugs were particularly prone to shortages and suggested they should be exempt from the anti-inflation law.
“Reimbursement for these drugs under government programs is very low and set above the marginal cost of manufacturing the drug, which is not the case for pill drugs, which are less likely to cause problems. No problem.”
“But for injectables, you need to leave a margin so people can reinvest in manufacturing equipment and make sure it’s high quality,” he added. “They’re not doing that, so things go wrong and there’s shortages as a result.”
A March report by the Senate Homeland Security and Government Affairs Committee found more than 295 drug shortages at the end of 2022, the highest level in five years.
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