Senate To Work With FDA To Craft Generic Biotech Rules

At a Senate Finance Committee hearing on Wednesday, Sen. Charles Schumer (D-N.Y.) told HHS Secretary Mike Leavitt that he had spoken with FDA Commissioner Andrew von Eschenbach about crafting a proposal that would give FDA the authority to regulate generic versions of biotechnology drugs and that the two agreed to "sit down and try to do something jointly," CongressDaily reports.

Schumer said that he and von Eschenbach agreed to revise Schumer's existing legislation instead of developing a White House bill. Leavitt said he would support the effort.

A Senate aide said that sticking points on the legislation are exclusivity periods granted to brand-name biotech drug makers for new treatments, user fees charged by FDA for regulatory approval of generic biotech drugs and interchangeability issues. Schumer's bill would grant 12 years of exclusivity to brand-name drug makers for new biotech drugs.

The Biotechnology Industry Organization, a trade group, has been pushing for 14 years of patent protection. In addition, last year Leavitt said the user fee model in Schumer's bill would not raise enough funds for FDA to regulate generic biotech drugs. In his fiscal year 2009 budget, President Bush proposed a user fee program for regulating generic biotech drugs, but he did not specify an amount or any other details.

Schumer's bill also would allow interchangeability of brand-name and generic biotech drugs at FDA's discretion. The Bush administration opposes interchangeability, saying that biotech drugs are more complex than traditional drugs and drug makers would have a harder time proving the drugs are the same (Johnson/Edney, CongressDaily, 2/6).