Government

As I was saying; look beyond the manufacturer 🤒 EpiPen Controversy Fuels Concerns Over Generic Drug Approval Backlog | Kaiser Health News

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.

Source: EpiPen Controversy Fuels Concerns Over Generic Drug Approval Backlog | Kaiser Health News

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4 replies »

  1. “In fact, most brand-name drugs are produced in the same countries and often the same factories as their generic counterparts. ” Citation? Do you mean most brand-name drugs sold in the U.S.?

    My impression has been that brand name drugs sold in the U.S. are made either here in the U.S. or Europe. Once the FDA opens the window for generics, the source then becomes India or China.

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    • Yes, sold in US. In fact, some generics are made here and the brand overseas. In some cases, the generic is actually the brand drug sold as a generic. It even has the brand name on the pill in the genetic bottle.

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  2. It appears to me that the FDA is in the damned if you do, or don’t arena.

    Most generics sold in the United States are made in either India or China. The FDA has been criticized by U.S. and European drug makers themselves, both generic makers and name-brand makers, for being far to lax in inspection of Indian and Chinese generic drug makers.

    I’m in the unusual, maybe unprecedented, position of requesting a much expanded federal agency, namely the FDA.

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    • Eighty percent of the active ingredients in all U.S. drugs—generic and branded—are now made in foreign countries. In fact, most brand-name drugs are produced in the same countries and often the same factories as their generic counterparts.

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