On August 18th, I wrote that pharmaceutical manufacturers should agree to voluntarily notify the FDA when they become aware of circumstances (manufacturing and otherwise) that might result in drug shortages,
(When I served at FDA we signed an MOU with PhRMA that required its member companies to inform the agency when instances of counterfeit medicines came to the attention of manufacturers. It got the job done – minus additional federal regulation.)
Shortly afterwards, Senators Amy Klobuchar (D, MN) and Bob Casey (D, PA) introduced legislation to require drug manufacturers to give “proper prior notification” to FDA when there is going to be a drug shortage.
Watch the Federal Register on Monday for an interim final rule from the FDA that requires manufacturers that are the only producers of critical drugs to report to FDA all interruptions in manufacturing processes, regardless of whether a drug shortage occurs. Previously, such manufacturers were only required to notify the agency when a drug shortage occurred. The rule goes into effect 30 days after being published.
This would have been a better and more interesting story if industry had taken the initiative rather than being directed to change its behavior.
(When I served at FDA we signed an MOU with PhRMA that required its member companies to inform the agency when instances of counterfeit medicines came to the attention of manufacturers. It got the job done – minus additional federal regulation.)
Shortly afterwards, Senators Amy Klobuchar (D, MN) and Bob Casey (D, PA) introduced legislation to require drug manufacturers to give “proper prior notification” to FDA when there is going to be a drug shortage.
Watch the Federal Register on Monday for an interim final rule from the FDA that requires manufacturers that are the only producers of critical drugs to report to FDA all interruptions in manufacturing processes, regardless of whether a drug shortage occurs. Previously, such manufacturers were only required to notify the agency when a drug shortage occurred. The rule goes into effect 30 days after being published.
This would have been a better and more interesting story if industry had taken the initiative rather than being directed to change its behavior.
