Earlier this week FDA published a list of drugs that don’t face competition from generic alternatives even though their intellectual property protections have expired. FDA said it will expedite the approval process for such applications “until there are three approved generics for a given drug product.”
.. the cost of developing a generic product can run into the millions of dollars, and many can’t fetch the profit to recoup the expense.
.. Consumers pay 94% of the branded price on average when one generic firm enters the market, but that drops to 52% with two competitors and to 44% with three, according to an FDA analysis... Lipitor, which cost $3.29 a unit before its patent expired. The generic version last year cost $0.11... One barrier to innovation is that some manufacturers are abusing FDA safety and risk mitigation regulations to protect monopoly positions.. Regarding EpiPen, FDA regulations helped keep a generic alternative off the market by requiring an identical device to deliver a shot of adrenaline… most generics are not approved on the first round, and revisions create substantial work for companies and FDA staff. The agency also has a backlog of applications and has struggled to hire enough staff to keep up with applications.
Shkreli and Turing have claimed that hospitals and insurance companies will pay, while patients who can’t afford it will get a discount, or get it for free. And Nancy Retzlaff, Turing’s chief commercial officer, told the committee about her company’s efforts to get the drug to people who can’t afford it. The arrangement she described sounded like a hodge-podge, an ungainly combination of dizzyingly high prices, mysterious corporate bargaining, and occasional charitable acts—which is to say, it sounded not so much different from the rest of our medical system.
.. The Daraprim saga has as much to do with the Food and Drug Administration as with Shkreli: although the drug’s patent expired in the nineteen-fifties, the F.D.A. certification process for generic drugs is gruelling enough that, for the moment, whoever owns Daraprim has a virtual monopoly in America. (Overseas, it is much cheaper.)
.. “Congress has not really vested any authority for the F.D.A. over pricing, so we do not follow that.”
.. you don’t have to agree with his assessment in order to appreciate the service he has done us all. By showing what is legal, he has helped us to think about what we might want to change, and what we might need to learn to live with.