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Congress Looks to Chart Biogenerics Pathway Legislation to provide a legislative pathway for biogenerics has been introduced in the House of Representatives and the Senate. Many believe action on the proposals is likely, given the current focus by the Obama administration and the Congress on achieving cost-saving reforms in the health care arena.

Rep Henry Waxman (D, CA), who chairs the House Energy and Commerce Committee, joined a bipartisan group of legislators in introducing HR 1427, the “Promoting Innovation and Access to Life-Saving Medicine Act.” The measure would allow the FDA to approve affordable copies of biotech drugs, currently the fastest-growing and most expensive components of the nation’s Rx drug bill.

“I believe this bill will lead to healthy competition and long-term savings for patients and payers and will preserve innovation in the biotech marketplace,” said Waxman. A companion bill, S 726, has been introduced by Sen Charles Schumer (D, NY).

The issue of market exclusivity—how long manufacturers of new biologics can be exempt from competition—is a matter of some dispute, however. Waxman’s legislation would provide a 5-year period before generic competition can be introduced. Another measure (HR 1548)—cosponsored by Rep Joe Barton (R, TX), ranking member of the House Energy and Commerce Committee— would give brand name manufacturers 12 years of exclusivity.

Generics Good for Health and Wallet

A new survey by the Blue Cross and Blue Shield Association (BCBSA) has found that community-based programs led by its members and employers are helping to expand patient use of lower-cost generic drugs.

The analysis of prescription use by 51 million Blue Plan members revealed that expanded use of generic drugs generated at least $2.5 billion in savings. “Generic alternatives to highpriced branded drugs help increase adherence to prescribed drug therapies and improve health care, while providing value to increasingly cost-conscious consumers,” said John Frick, RPh, director of pharmacy initiatives for BCBSA.

The insurer reports that in upstate New York, for example, generic drug use increased 14.6% and saved more than $725 million since late 2005. Excellus Blue Cross Blue Shield used a combination of outreach strategies, such as television ads and online tools, to educate employers, patients, and providers about generics.

FTC, Legislators Want to Stop Pay-for-Delay Deals

Senior members of the Senate Judiciary Committee, Sen Herb Kohl (D, WI) and Chuck Grassley (R, IA), recently introduced The “Preserve Access to Affordable Generics Act” (S 369), legislation that would prohibit brand name drug manufacturers from paying their competitors to keep cheaper generic equivalents off the market.

The Federal Trade Commission (FTC) testified recently in support of legislation banning pay-for-delay settlements, before a subcommittee in the House where a companion measure, HR 1706, also is pending.

FTC Commissioner J. Thomas Rosch, appearing before the House Subcommittee on Commerce, Trade, and Consumer Protection, said that the anticompetitive patent settlements “impose enormous costs on consumers and the health care system,” and that congressional action to prohibit them is “both appropriate and timely.”

Research Finds Generics Would Help Plug Doughnut Hole

Researchers at the University of Pittsburgh, Graduate School of Public Health, report that beneficiaries enrolled in Medicare Part D who reach the gap in coverage known as the “doughnut hole” are much less likely to maintain their prescription drug regimens than those with generic coverage or an employer-based plan.

The findings, published in the February 3, 2009, online issue of Health Affairs, raise concerns about health consequences and increased costs due to lack of coverage. For the study, the researchers examined the drug-buying habits of 11,000 Medicare beneficiaries. They found that about 25% reached the coverage gap, and these patients typically had chronic conditions like diabetes, hypertension, and hyperlipidemia.

Medicare beneficiaries who lacked coverage in the doughnut hole reduced their monthly prescriptions by 14% per month, but those with generic coverage in the doughnut hole decreased them by only 3%, according to the study.

To fill the gap, the researchers suggest mandating coverage of generic drugs in the doughnut hole and offsetting government costs by allowing plans to assess larger copays on prescription drugs prior to entering the coverage gap.

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