The Bush administration on Thursday announced new rules that would hurry generic drugs to market by making it harder for the makers of brand-name versions to block the competition.
The change, effective on Aug. 18, limits brand-name companies to only one 30-month stay blocking a generic drug's entry into the market. Companies frequently sue when generic competitors file an application for their product with the Food and Drug Administration, claiming the generics infringe on their patents.
A lawsuit automatically triggers a 30-month stay delaying FDA consideration of the generic and brand-name companies can file repeated lawsuits, meaning multiple 30-month stays.
The administration said the move will save consumers $35 billion over 10 years by making less-expensive generic alternatives available more quickly. A generic version of a $72 average brand-name prescription costs about $17, the administration said.
"The increased availability of lower-cost generic drugs will benefit all Americans, especially seniors," Health and Human Services Secretary Tommy Thompson said.
The FDA had first proposed the new rule preventing brand-name companies from filing multiple lawsuits last fall, and finalized it a day after a key Senate committee approved legislation that would go even further.
The Senate bill also would block multiple lawsuits, but includes other steps to thwart delays in the sale of cheaper generic versions — including abuses in which the brand-name maker pays its generic competitor to stay out of the market.
Those patent-related delays aside, the FDA is planning to shave another three months off its consideration of a generic application, currently a 20-month process. Basically, the change means better advice to generic manufacturers, through meetings and new industry guidelines, on how to file a drug application that is approvable on the first try. Today, these small companies often must re-file the same application before getting it right.
The changes come in addition to $13 million that President Bush is seeking to add to FDA's 2004 budget for generic drugs, increasing the program's size by about one-third.
The FDA generally can approved a generic drug as soon as the patent protection on its brand-name counterpart expires or when a court determines the generic will not infringe on the innovators' patent.