Congress still working on biologic generics bill

August 11, 2008

Congress continues to work to create a regulatory pathway for approval of generics for biopharmaceuticals (or biologics), but passage of such legislation seems unlikely this year with the presidential election rapidly approaching.

Congress continues to work to create a regulatory pathway for approval of generics for biopharmaceuticals (or biologics), but passage of such legislation seems unlikely this year with the presidential election rapidly approaching.

In April the House Energy and Commerce Subcommittee on Health sent a questionnaire to 35 stakeholder groups. It contained 40 questions on how the Food and Drug Administration's (FDA's) new approval pathway for biopharmaceuticals should work. The subcommittee subsequently posted the responses on its Web site.

Representatives Frank Pallone Jr. (D, N.J.), subcommittee chairman, and Nathan Deal (R, Ga.), ranking Republican, hope the responses will promote consensus efforts. Although there is wide agreement on the need for some abbreviated way of approving generic biologics, there is disagreement on how easily or quickly that approval process should be. And there are billions of dollars at stake between the biopharmaceutical brands and the generics industry.

Last year the Senate Health Education Labor and Pensions (HELP) committee unanimously passed a biologic generics bill (S.1695), but it has yet to go to the Senate floor. HELP committee staffers say there are technical issues in the bill that may need to be changed, and that senators are not likely to schedule valuable floor time until there is movement in the House.

Others speculate that the Senate bill has stalled due to the illness of committee chairman Sen. Edward Kennedy (D, Mass.), who has been diagnosed with a brain tumor.

Meanwhile, that Senate bill received the coveted endorsement from the Congressional Budget Office (CBO) when the CBO reported that the legislation would reduce expenditures on biologics by $0.2 billion between 2009 and 2013 and by about $25 billion between 2009 and 2018.

As the CBO noted, the bill would allow the FDA to use the literature of the agency's safety and effectiveness findings for the original product to approve a follow-on product, thus allowing the follow-on manufacturers to avoid substantial research and development expenses, including large clinical trials to show safety and effectiveness. However, the question of how much research should be done on generic versions is one of several areas where there is disagreement.

For example, in its 40-page response to the House subcommittee, the Pharmaceutical Research and Manufacturers of America (PhRMA) argued, "Evidence of molecular similarity will need to be shown for all FOBs [follow-on biologicals] using physical and chemical analytical techniques current at the time of FOB application. ... FOBs will be similar to the reference product, rather than identical, and thus their clinical profiles could differ from those of the reference product."

Because of that, the industry's letter said, "There is no scientific justification for basing approval of a biological product solely on clinical data derived from a different biological product made by different manufacturing processes. Therefore, clinical trials should be required to demonstrate the safety and effectiveness of all FOBs."

On the other hand, the Consumers Union told the committee, "Clinical trials for an FOB should be the exception and not the rule and only required in special circumstances at the discretion of the FDA."

If no legislation passes this year, the issue is likely to continue in the next Congress, given the potential savings involved.

On a related front, there is no visible movement on a bill to prohibit brand-name drug companies from compensating generic drug companies to delay marketing a generic drug that would compete with their brand drug.

In May the Federal Trade Commission (FTC) reported that in fiscal 2007 there were 14 final settlements between brand companies and generics companies that included both compensation to the generics manufacturer and a restriction on that manufacturer's ability to market its product.

That number was the same as in fiscal 2006 but 11 more than in fiscal 2005.

THE AUTHOR is a writer based in the Washington area.