Washington Editor

WASHINGTON - Biogeneric supporters are looking forward to next week's new congressional session, during which they plan to push hard for a shortened approval pathway for such products.

"Now is the time for action," said Kathleen Jaeger, the president and CEO of the Generic Pharmaceutical Association, in a recent conference call to outline that organization's legislative priorities in the coming year. Noting that biological drug sales are growing at nearly twice the rate of traditional pharmaceuticals, she said they presently account for about $35 million of all domestic drug sales. "But this growth will be meaningless if Congress does not address cost and access."

In contrast, those in the opposite camp, representing pioneer drugmakers, have been arguing that most lawmakers don't yet fully grasp the biogeneric issue. As Ian Spatz, the vice president of public policy at Merck & Co. Inc., recently told BioWorld Today, the whole matter has yet to mature to the point for Congress to act. "It's a hard thing to figure out," he said, echoing the thoughts of others who point to safety issues that arise from questions around heterogeneity, immunogenicity, interchangeability and bioequivalence.

In the absence of recent hearings and other public vetting on biogenerics, Spatz said he doesn't expect the typically slow-moving body to be in a position to react quickly on such legislation, especially within the fairly short reauthorization time frame on the Prescription Drug User Fee Act.

Jaeger, on the other hand, believes it's "very doable" in the coming Congress. Legislation introduced early this year is certain to be brought up again, and it's worth noting that several large consumer and retiree groups are lending their muscle to the biogeneric movement.

In addition, Jaeger said most legislators are up to speed on the issue. "We believe that a lot of policy-makers are familiar with the concept of generic biopharmaceuticals," she told BioWorld Today. "We've been educating them on the Hill for the last year or two."

GAO Reports On FDA Ad Reviews

A recently released analysis by the Government Accountability Office noted that the FDA needs to more quickly review direct-to-consumer drug advertising, essentially saying the agency needs more staff.

From 1997 through 2005, when drugmakers paid more than $4.2 billion for DTC ads, such spending grew at twice the rate of outlays on promotion to physicians or research and development, though expenses for the latter two still outstrip DTC ads. Nevertheless, the GAO report pointed to DTC advertising's impact on increased drug use and spending, with positive and negative consequences for consumers.

In the same time frame, the FDA has been unable to keep pace with DTC ad growth, meaning the agency cannot quickly issue violation letters to limit exposure to false or misleading advertising. To amend that, the GAO report recommended that the FDA document criteria for prioritizing DTC materials for review, apply those criteria to materials it receives and track those that it reviews.

In response, the FDA's parent agency, the Department of Health and Human Services, said such recommendations would require vastly increased staff. In the background of that is talk that there will be a DTC ad fee-for-service component to the next version of the Prescription Drug User Fee Act, in which drugmakers that want to use ads will pay for their review.

The U.S. is one of only two nations that allow DTC ads. The other is New Zealand.

SRI Contracted For Chemical Countermeasures

The nonprofit research and development group SRI International Inc. received a $9.5 million contract from the National Institute of Neurological Disorders and Stroke to further develop recently discovered countermeasures for chemical terrorism agents such as nerve agents, chlorine gas, cyanide and vessicants.

The organization, of Menlo Park, Calif., will evaluate candidate therapies identified in earlier-stage projects supported by the National Institutes of Health's CounterACT program, which cuts across the various institutes to develop improved medical countermeasures for chemical threats.

"This is basically a support contract," said Carol Green, senior director of toxicology and metabolism in SRI's biosciences division and the principal investigator for the new program. "We'll be working closely with other investigators in the network who receive grants."

The R&D organization will focus on the preclinical development of potential therapeutics by developing analytical methods, performing pharmacology studies and safety evaluations, and formulating and manufacturing products for further study. In short, SRI will work "on anything that's needed" to get products to the point of investigational new drug applications for the FDA, Green told BioWorld Today.

SRI, which recently received a $57 million contract from the National Institute of Allergy and Infectious Diseases for the development of anti-infective therapeutics, is the largest preclinical development contractor to the NIH. The organization was founded as the Stanford Research Institute in 1946.