FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Flags Longer and More Intense Drug Shortages

Dec. 7, 2018
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Drug shortages have increased in both length and intensity over the past year, according to FDA officials who spoke at a public meeting on the issue in Washington, D.C.

The agency has limited options to address the shortages as it can’t require a company to disclose details behind why a shortage occurs or to make more of a drug, noted Matthew Rosenberg, an operations research analyst at the agency.

“[W]e certainly don’t have easy solutions, or we would have fixed this problem a long time ago,” said FDA Commissioner Scott Gottlieb. In some cases, he said, the prices have been driven down to such low levels that it makes it hard to manufacture them profitably and have enough margin left over to invest in modern manufacturing upgrades.

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