Washington Editor

WASHINGTON - New legislation to empower the FDA to define pathways for biogeneric approvals is on the short-term horizon, Rep. Henry Waxman (D-Calif.) said Tuesday at a meeting of the Generic Pharmaceutical Association (GPhA).

A long-time industry ally, the 15-term congressman said he'd like to introduce such a bill before the current congressional session ends, and possibly in the next couple of weeks before the coming mid-term election hiatus.

For generic drugmakers that have long awaited FDA guidelines on the issue, the measure can't come soon enough.

"While the Hatch-Waxman bill is working as well as we could have hoped, it's not doing all that we need it to do," Waxman said. "One of the most important steps that we can take now is to ensure that the Hatch-Waxman [law] applies to all types of drugs."

Such a fix would permit the FDA to develop a mechanism for evaluating and approving biogenerics. The agency's chief counsel, Sheldon Bradshaw, agreed that "it would require legislation" to provide that power to the FDA. But beyond that, he stressed the importance of establishing uniformity between follow-on and pioneer products. "If it's a protein that can't be characterized," he told BioWorld Today, "it would be impossible to say that it's equivalent to whatever the reference listed drug is. So part of it's just driven by the science."

Conceding the uniqueness of biologicals, Waxman echoed such thoughts in noting that "we need a case-by-case approach" for evaluating each type of product.

He suggested that his Senate colleagues ought to use Acting FDA Commissioner Andrew von Eschenbach's confirmation proceedings as a platform to press for such legislative changes, as did Bruce Downey, the chairman and CEO of Barr Pharmaceuticals Inc., of Woodcliff Lake, N.J. The company is acquiring Pliva dd, of Zagreb, Croatia, which will provide entry to the biogeneric field.

"The time has come to break this monopoly," Waxman said. "We need it, we've needed it and we've got to get this going."

Underscoring that comment was Sandoz GmbH's vice president and general counsel, Eric Pomerantz, who said it "needs to happen now." Earlier this year, his company's human growth hormone product Omnitrope (somatropin [rDNA origin]) finally received FDA clearance after a protracted review and subsequent lawsuit by Holzkirchen, Germany-based Sandoz.

Such a legislative change would involve an amendment to one of two laws, the Food, Drug and Cosmetic Act that has provided for FDA approvals of insulin and human growth products, or the Public Health Service Act, under which the agency has licensed most other biological products through Section 351 of the law. The Hatch-Waxman Act established shortened approval pathways under Sections 505 (b)(2) and 505 (j) of the Food, Drug and Cosmetic Act, but made no such provisions to the Public Health Service Act.

"If you want generic versions of any biological license under Section 351 of the Public Health Service Act," Bradshaw said, "you need additional legislation."

While Waxman didn't specify any route in particular, "it would seem most logical" to amend that law given its relationship to biologicals, GPhA Vice President of Government Affairs Bruce Lott told BioWorld Today. Of note, he said, there is "a tremendous amount of interest" to move quickly on legislative changes on the part of employers, insurers and Congress, as biologicals are becoming a bigger and bigger part of overall health care costs, even as many of the products begin to lose patent protection. In addition, four state governors recently filed citizen petitions with the FDA to press for the agency's long-promised guidance on follow-on biopharmaceuticals.

Other congressional members who have expressed a desire to advance the matter include Sens. Orrin Hatch (R-Utah), Patrick Leahy (D-Vt.) and Hillary Clinton (D-N.Y.). That momentum, Lott said, represents "a real opportunity" for advancing biogenerics.

Waxman said that he doesn't expect his coming proposal to get put on the back burner because of renewal negotiations around other health care legislation, such as the Prescription Drug User Fee Act, which expires in a year. Still, he conceded that it would be "an uphill battle" to advance his legislation against pioneer drugmakers. Their typical argument is that equivalence between biological products cannot be established and that shortened biogeneric approvals would erode innovation. But Downey said that research and development spending would increase as it did in the mid-1980s after the Hatch-Waxman Act became law.

"I believe we can and must achieve a consensus around an approach and move forward united around one bill," Waxman said, calling for bipartisanship in crafting his proposed measure. "Indeed, it's critical that we do so. Remember, when we try to enact this legislation, we will be facing a common foe that will speak in unity in fighting against us."