CQ TODAY ONLINE NEWS
July 14, 2009 – 10:40 a.m.
Committee Closer to Finishing Health Overhaul
By Adjoa Adofo, CQ Staff
Spurred on by President Obama, one Senate committee is nearing completion of a massive health care overhaul bill after Republicans scored a rare victory on a provision involving biotech drugs.
The Senate Health, Education, Labor and Pensions Committee resumed its marathon markup Tuesday morning, hoping to complete action on its bill by the end of the day.
But the Senate Finance Committee has yet to begin a markup of its version of the health care overhaul, one that is expect to conflict with the HELP measure in some key aspects.
Obama is pressing both panels to finish their work quickly. He has called upon the House and the Senate to pass health care legislation before they leave Washington for the August recess.
Late Monday, the HELP panel approved a portion of its bill authorizing the Food and Drug Administration to approve generic versions of expensive biologic drugs — those derived from proteins, rather than chemicals. Ordinary pharmaceuticals have faced generic competition for more than two decades, but biologics have not up until now.
Sherrod Brown , D-Ohio, offered an amendment that sought to limit to seven years the exclusive marketing rights a company could claim for a new brand-name biologic drug. But that amendment was rejected, 5-17.
Instead, the committee adopted by 16-7 an amendment by Orrin G. Hatch , R-Utah, that would provide 12 years of market exclusivity for new biologic products.
Only one Republican — John McCain of Arizona — opposed the Hatch amendment. Seven Democrats joined nine Republicans in voting for it: Bob Casey , Pa.; Kay Hagan , N.C.; Edward M. Kennedy , Mass. (by proxy); Barbara A. Mikulski , Md.; Patty Murray , Wash.; Jack Reed , R.I., and Sheldon Whitehouse , R.I.
Makers of brand-name biologics wanted 14 years of exclusivity for new biologic drugs, while makers of generics and some Democrats argued for a much shorter period.
Hatch, who coauthored the 1984 Hatch-Waxman Act (PL 98-417) that first established the process of FDA approval of generic drugs, pressed for committee action on his 12-year period of exclusivity for new biologic products. Mikulski backed his amendment, saying it would encourage drug manufacturers to invest in drug innovation.
“The fact is that it takes a long time to develop a product,” Mikulski said. “About 97 percent of products will fail during clinical trials. Of those who make it past the clinical trials, only 30 percent will garner profits equal to the amount of money put to develop the product.”
Judd Gregg , R-N.H., said drug developers need some assurance that they can make a reasonable return on their investments.
“Money doesn’t flow into biologics out of good will and altruism,” Gregg said. “Money flows into biologics because the capital is there to make money.”
But Brown and a small group of other Democrats said longer periods of market exclusivity allow companies to drive up the cost of drugs, burdening insurers and the sick who need the treatments.
“If we do this giveaway for these drug companies it means profits are up for them, it means salaries are up for them, but let’s think about the patients,” Brown said.




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