FDA Modernization: Patients Council View Of Senate Bill

As the Marketletter went to press last week (July 24), the US Food andDrug Administration Modernization bill was expected to arrive on the Senate floor (see page 13 for details).

Michael Langan of the Patients Council told the Marketletter that causing the most problems is a lack of compromise in the bill's national uniformity and preemption sections; there is no agreement and none is close. California Senator Diane Feinstein is concerned about her state's Proposition 65, and if no deal is reached, Senator Edward Kennedy and some Democrats are unlikely to agree to a time limit on the debate; Senate Majority Leader Trent Lott does not want the bill to go to the floor without a time limit, Mr Langan said.

The Council says measures to improve Phase IV post-marketing surveillance with efficacy studies and requiring a notice of discontinuance where there is a sole manufacturer for a specific indication should be added to the bill, Mr Langan told the Marketletter. During its markup, Sen Kennedy sponsored the Phase IV proposal as an amendment, and while it was not enacted during markup, it is expected that someone will offer it as an amendment when the bill goes to the floor.