Who Makes This Drug? Disclosing The Identity Of Generic Drug Manufacturers

October 16 01:00 2015 by ushadmin

Counting and identifying manufacturers able to supply the U.S. with generic drugs or their base ingredients is critical for promoting the following public health goals:

Forecasting national spending on generic drugs;

Planning patient treatments when supply interruptions and shortages occur or are threatened; and,

Choosing manufacturers with a demonstrated commitment to quality production.

Yet the number and identity of these manufacturers is shrouded from public oversight. In June 2015, we argued in a U.S. Food and Drug Administration (FDA) hearing convened on the occasion of the 2012 Generic Drug User Fee Amendments (GDUFA) reauthorization that the U.S. Congress should authorize the FDA to increase public oversight into generic drug manufacturing.

In the following blog post we list our recommendations, mainly that the U.S. Congress:

Authorize the FDA to make public information on the location of the manufacturing facility sites for each generic drug;

Consider restructuring GDUFA user fees to mitigate incentives for the outsourcing of drug manufacturing; and,

Consider creating new incentives for firms to enter into the manufacturing of generic drugs, especially among specialty drugs that have recently experienced price hikes and supply interruptions.

We conclude by discussing the underlying rationales for these recommendations…