When I served at FDA we signed an MOU with PhRMA that required its member companies to notify the agency when instances of counterfeit medicines came to the attention of manufacturers.
It got the job done – minus additional federal regulation.
Today we face a different problem – drug shortages – but a similar decision tree: regulation or public-spirited public health cooperation.
Minus the latter, we will get the former.
Senators Amy Klobuchar (D, MN) and Bob Casey (D, PA) have introduced legislation to require drug manufacturers to give “proper prior notification” to FDA when there is going to be a drug shortage.
Further, Klobuchar (D, MN) and Richard Blumenthal (D, CT) have formed a bipartisan group to work on the issue of drug shortages.
At their request, the FDA will hold a hearing on the matter September 21, and the General Accounting Office will review the problem.
It’s time for FDA and PhRMA to get the job done.
Legislation takes longer and leads to mission creep.
