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Biogenerics Bill Wins Surprise Support From GOP Senators, Industry

A Democratic proposal to establish a new regulatory route for inexpensive biological medicines took a major step forward today as several Republicans and industry officials voiced their agreement with the plan in principle.

Senate Republicans, including Mike Enzi (R-Wyo.), Orrin Hatch (R-Utah) and Tom Coburn (R-Okla.), joined by a range of industry officials, announced their support for a proposal that would accelerate approval of generic biologics during today’s Health, Education, Labor and Pensions Committee hearing.

The hearing was called to consider a bill (S. 623) offered by Sen. Charles Schumer (D-N.Y.). Rep. Henry Waxman (D-Calif.) has introduced companion legislation (H.R. 1038) in the House.

The bills would develop a protocol for the Food and Drug Administration to review and approve generic versions of biological products. Biologics are products such as vaccines and antitoxins that are made from living organisms and used to treat or prevent diseases. The sponsors hope to use generics to drive down patients’ medical costs.

The amount of support surprised co-sponsor Sen. Hillary Rodham Clinton (D-N.Y.), who said Republican opposition had been “a concern.” Democrats had expected “blanket opposition” to their plans, she told CongressNow. Instead, “there seems to be agreement” that a new pathway is needed.

However, hurdles remain for the bill. Republicans and industry witnesses from companies such as Johnson & Johnson agreed that S. 623 needed more detailed language requiring tests of the safety and efficacy of these products as part of the approval process. While the bill gives the FDA the authority to require such clinical trials, that language was not enough for Hatch.

“I can’t support it” without more detailed requirements for these tests, known as clinical trials, he said.

Clinton pledged to work with Hatch to craft language that would clarify the clinical trial requirements companies must meet to get their products approved. The bill’s proponents will also call a range of experts to give advice on this language, she added. “We know this is just the beginning” of the crafting of the bill.

The Biotechnology Industry Organization is among the groups that oppose a biogeneric pathway. BIO, which represents biotech firms, argues that these products are too complex to create generic versions. Also, Jim Greenwood, the group’s president and CEO, said in a March 8 statement that efforts to rush the development of such a pathway puts public health and future innovation at risk.

“Even small changes between follow-on biologics and an original biotechnology medicine can cause differences that may have an impact on patient safety,” he said.

The lawmakers also must take steps to protect the intellectual property rights of biotech manufacturers, Greenwood said. Without sufficient protections, innovation will be undermined, he added.

Lawmakers such as Sen. Edward Kennedy (D-Mass.) have considered using reauthorization of the Prescription Drug User Fee Act as a vehicle for biogenerics. These fees, which account for hundreds of millions of dollars annually, are due to expire Sept. 30. But given the complexity of these issues, it may not be feasible for lawmakers to attach biogeneric language to pending legislation to reauthorize drug user fees, as some lawmakers have proposed.

Time is too short to adequately address these issues and reauthorize the fees before they expire, Greenwood said. “Attaching follow-on biologics legislation to PDUFA would potentially jeopardize reauthorization of the user fee program to the detriment of patients waiting for new therapies, FDA’s internal scientific capabilities, and biomedical innovation.”

Clinton was noncommittal about using PDUFA as a vehicle. “We will discuss all of that,” she said. “I don’t want to prejudge.”

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