Lawmakers' Proposal Giving FDA Authority Over Generic Biotechnology Drugs

Armen Hareyan's picture

Generic BiotechnologyDrugs

At a Senate Finance Committee hearing on Wednesday, Sen. Charles Schumer (D-N.Y.) told HHSSecretary Mike Leavitt that he had spoken with FDACommissioner Andrew von Eschenbach about crafting a proposal that would giveFDA the authority to regulate generic versions of biotechnology drugs and thatthe two agreed to "sit down and try to do something jointly," CongressDailyreports. Schumer said that he and von Eschenbach agreed to revise Schumer'sexisting legislation instead of developing a White House bill. Leavitt said hewould support the effort.

A Senate aide said that sticking points on the legislation are exclusivityperiods granted to brand-name biotech drug makers for new treatments, user feescharged by FDA for regulatory approval of generic biotech drugs andinterchangeability issues. Schumer's bill would grant 12 years of exclusivityto brand-name drug makers for new biotech drugs. The Biotechnology Industry Organization, a trade group, has been pushing for 14 yearsof patent protection. In addition, last year Leavitt said the user fee model inSchumer's bill would not raise enough funds for FDA to regulate generic biotechdrugs. In his fiscal year 2009 budget, President Bush proposed a user feeprogram for regulating generic biotech drugs, but he did not specify an amountor any other details. Schumer's bill also would allow interchangeability ofbrand-name and generic biotech drugs at FDA's discretion. The Bushadministration opposes interchangeability, saying that biotech drugs are morecomplex than traditional drugs and drug makers would have a harder time provingthe drugs are the same.

Leavitt said, "Biologics are an important medical development,"adding, "We'd like to see them expanded in their generic form. We'reanxious to see a bipartisan proposal" (Johnson/Edney, CongressDaily,2/6).

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