Washington Editor

WASHINGTON - Word that negotiations for renewing the Prescription Drug User Fee Act could serve as a vehicle for passing biogeneric legislation has arisen of late, but a generic industry insider recently told BioWorld Today that it doesn't appear to have much traction.

Comments on the biogeneric legislation came during a recent meeting of the Generic Pharmaceutical Association, which argues that the FDA has existing authority to approve those products under a shortened pathway, but the group also supports more definitive legislative. The Arlington, Va.-based organization's conference wasn't related to an approval pathway, but the matter never seems far from people's minds these days.

Discourse related to biogenerics has heated up over the past month since Rep. Henry Waxman (D-Calif.) introduced a bill that would give the FDA legal powers to authorize them, with companion legislation introduced in the upper chamber by Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.). In addition, there has been talk of committee hearings on the subject before the end of the year. (See BioWorld Today, Sept. 20, 2006, and Sept. 26, 2006.)

More recently, at a venture capital conference here, drug industry observers said the "Access to Life-Saving Medicine Act" could be worked into ongoing discussions on PDUFA, which is expected to be renewed with elements of drug safety reform added.

But at the same event, a staffer on the Senate's Health, Education, Labor and Pensions Committee familiar with those negotiations indicated that the biogeneric issue wouldn't enter the dialogue because the fourth version of the user fee law is nearly complete. In addition, he said lawmakers' understanding of the matter remains fairly thin, so it probably would take a couple of years before legal changes take effect.

Still, the GPhA remains hopeful for quicker action and sees nearer-term catalysts for changing the FDA's policy on biogenerics. In particular, other pending health care-related legislation beyond PDUFA could help boost discussion of the biogeneric bill, and the coming elections could impact the debate if the GOP loses control of one or both congressional chambers.

CMS To Collect Drug Data

The Centers for Medicare & Medicaid Services issued a proposed regulation to use Part D claims data for a range of research activities into the health care system.

Under the proposal, Medicare drug claims would be linked to other patient care information such as hospitalizations and physician visits and made available to the FDA, the National Institutes of Health, the Agency for Healthcare Research and Quality and academic researchers for studies with requisite privacy protections. For example, the agency said they could use the data to mine for side-effect information in clinical circumstances of concern, to determine potential cost savings in chronic disease management and identify patients who aren't receiving evidence-based recommended drug therapies.

CMS has invited the public to comment on the proposal through Dec. 18.

Chevron Signs Up With BIO

The Biotechnology Industry Organization has added another petroleum firm to its membership: Chevron Technology Ventures LLC, a wholly owned subsidiary of Chevron Corp. The addition signals another boost for industrial biotechnology, which BIO promotes as a transformative development for the future of fuels and consumer products. Among other traditional oil companies that have joined the Washington trade association this year is BP.

Ex-FDA Chief Pleads Guilty

Former FDA Commissioner Lester Crawford pleaded guilty last week to federal charges that he did not disclose ownership of stock in companies regulated by the agency. Reports indicated that he had interests in both food firms and businesses with health care-related consumer products, but not any drugmakers.