In a previous post I noted that part of the problem of drug costs can be traced to our own FDA bureaucracy. Here is a good example of what I was referring to. Four years for genetic approval in the US vs one year in Europe. Europe is often held up to us as the model for lower health care costs. I wonder if being more efficient has anything to do with it?😷
The Obama Administration likes to throw about “competition” in health care, well here you go have at it.
Consumers and Congress members pushing for cheaper alternatives to the EpiPen and other high-priced drugs are seeking answers about a stubborn backlog of generic drug applications at the Food and Drug Administration that still stretches almost four years.
As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months, according to the Generic Pharmaceutical Association, or GPhA.
The FDA has approved more generics the past few years, but a flood of new applications has steadily added to the demand. By comparison, the European Medicines Agency, Europe’s version of the FDA, has just 24 generics or biologically-based “biosimilars” awaiting approval. (The FDA’s count does not include biosimilars.)
And the EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand name drugs in about a year on average, according to the EMA. Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long.