How the F.D.A. Makes Your Drug Costs Higher

Five years ago, the F.D.A. typically approved a new generic drug within 16.3 months of the application’s filing, according to a report from the agency. But by last year…approvals for new generic drugs were taking 26.7 months… “It’s a real problem,” Dr. Margaret A. Hamburg, the F.D.A. commissioner… The generics industry has saved consumers nearly $750 billion over the last decade.

Full article on why generic drugs are facing longer wait times for approval.

Comments (6)

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  1. Ken says:

    Amazing. Looks like Obama could save the whole country $75 billion a year just by speeding up approvals. To put that in perspective, you could probably insure all the long term uninsured for that amount of money.

  2. Brian Williams. says:

    This is a good example of how government mediocrity can be more than just a nuisance, it can kill people.

  3. Joe S. says:

    Not sure your numbers are right, Ken. But this kind of delay does seem inexcusable.

  4. Devon Herrick says:

    With the possible exception of over-the-counter drugs, generic drugs are the most efficient way to treat many illnesses.

    The Administration is proposing to spend $1 trillion over the next decade on universal coverage (or about $250 billion annually once the program is fully implemented). Yet it only spends $51 million annually on approving new generic drugs? Talk about lopsided priorities.

    The drugs whose applications are pending have already been used by the American public for around a decade as brand-name drugs. Why the hold up?

  5. Linda Gorman says:

    Took a while but the point of the article finally became clear at the end where it notes that the FDA is asking Congress to pass more user fees on the people asking for the approvals.

    Cutting costs and setting spending prorities is hard, so the agency pulls out the good old Washington Moument strategy.

  6. John R. Graham says:

    The failure of a government agency to meet its performance metrics results in more money for that government agency. The generic pharmaceutical industry will soon learn that the FDA’s incentives, after having devoured the user fees, will be to slow down and come back in a couple of years for yet more money. The user-fee approach will likely result in even longer waiting times and lost savings for patients.