That’s not surprising, though, is it?

President Bush’s budget includes $16 million annually to review applications from generic drugmakers to pay for review of their medicines. The idea, according to the White House, is to reduce FDA review time and speed the rising number of generics to market. Brand-name drugmakers, of course, already pay user fees, which are supposed to rise to $339 milllion. But generic drugmakers have never been asked to pay user fees before - and they’re steamed.

In a blunt statement, Kathleen Jaeger, who heads the trade group for generic companies, says: “User fees alone are not the magic bullet for speeding up drug approvals. If the Administration’s goal is to get safe, effective and affordable generics to consumers faster, then it must work with Congress to remove existing barriers that are delaying access to generics and increasing health care costs. FDA can hire more reviewers and speed up reviews, but if it doesn’t deal with barriers like authorized generics and citizen petitions, affordable generics won’t reach consumers any faster.”

Hmm….Wonder if this was suggested by someone at Phrma?

[tags]FDA, Generics, GPHA, Phrma[/tags]