HHS ON ORPHAN DRUG AMENDMENTS

The deputy assistant secretary for health at the US Department of Health and Human Services, Bill Corr, has proposed that the amendments to the Orphan drug Act (HR 4160) should include a provision that orphan products whose sales fall below given levels during their first four years on the market should receive a guaranteed additional three years' market exclusivity.

He told a hearing of the House Energy and Commerce Comittee health subcommittee that while the Administration supports HR 4160's attempts to resolve the controversy and uncertainty which surround moves to amend the Orphan Drug Act, it is concerned that in its present form the bill retains some degree of uncertainty regarding the terms under which a three-year extension would be granted.

Proposing the automatic three years' exclusivity, Mr Corr said the Administration did not believe it necessary in these instances to allow for the consideration of other criteria, although in other situations this might not be the case, and the HHS Secretary should be given the discretion to determine what those other criteria should be, along with the sales threshhold.