Obama budget aims to speed generics to market

Branded and generics makers both have something to complain about in President Obama's proposed budget for 2012. Two proposals, to be exact: One that would allow the Federal Trade Commission to crack down on cash settlements in patent-dispute cases, and another that would shorten the exclusivity period on biologic drugs. Both measures are designed to get copycat meds to market more quickly.

It's no mystery why branded drugmakers would oppose the very idea. Drugmakers are already suffering from generic competition, posting sales declines as copycats take a slice out of megablockbuster products and cutting forecasts in anticipation of new generic rivals.

So, anything the feds do to encourage generics only adds to the pain. "While we understand the need to reduce the deficit, policies such as these represent the wrong approach," PhRMA's new chief, John Castellani, said in a statement, pointing out that the 12-year exclusivity period on biologics was "the only provision" in the healthcare reform law "to garner strong bipartisan support."

The generics industry isn't happy, either--or not completely happy. GPhA cheered the proposed shortening of biologics exclusivity to seven years from 12 years; knocking off expensive biologic drugs is a big new field for copycat drugmakers, and the more meds they can try to copy, the better for them. But the group said empowering FTC to go after patent deals was "misguided," the Wall Street Journal reports.

- see the statement from PhRMA
- get the news from Reuters
- read the WSJ piece