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.