FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

AHA Suggests Ways to Mitigate Drug Shortages

Jan. 23, 2019

The American Hospital Association urged the FDA to seek authority from Congress to require more stringent disclosures by drugmakers to help limit prescription drug shortages.

Drugmakers are currently required to notify the agency of any changes in production that are “reasonably likely” to cause a drug shortage, but they aren’t required to provide reasons for halts in production, AHA said in a comment to the agency.

Companies should have to report the problem causing the manufacturing interruption, the degree of shortage and how long it’s expected to last — with a monetary penalty for those who fail to do so promptly, the association said.

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