Sen. Sherrod Brown of Ohio has been the leading voice in the Senate on the issue of biologics, the expensive drug treatments made from living organisms, and his advocacy for affordable, generic versions of the potentially life-saving drugs will continue once the Senate health care bill hits the floor.
The Senate HELP Committee version of the health care bill included an amendment sponsored by Kay Hagan (D-NC), Orrin Hatch (R-UT) and Mike Enzi (R-WY) which extended the patents on biologics to 12 years, and allowed drugmakers who tweak the formula of the drug slightly to restart the clock on the patent, essentially making it “evergreen.” Sen. Brown proposed a less stringent version, allowing generics to be created after only seven years, and eliminating the evergreen provision. His effort failed in the committee.
But Brown is prepared to keep up the fight. His office confirms that he will be working to round up support for his biologics legislation on the Senate floor. Because the final Senate bill has not yet been released, it’s unclear what the language will contain. But Sen. Brown prefers an approach with a smaller limit to the patent length and without the evergreen language, and he has introduced legislation to that effect in the Senate. Brown’s office tells me he has been working on this legislation for a while, and has the support of the AARP, Consumers Union and other advocacy groups.
“Sen. Brown considers evergreening to be just an endless monopoly period, and it’s not in the interest of consumers,” a spokesman told me. Brown has spoken on the Senate floor about the high cost of these biologics, which could reach $50,000 a year, a cost out of reach of many of the patients who need these drugs. Brown’s office believes their legislation would both lower costs and improve care.
The Federal Trade Commission’s report on follow-on biologic drugs noted that generics would increase competition, provide life-saving drugs at an affordable price, and actually promote innovation in the marketplace, unlike a 12-year exclusivity period, which according to the report would stifle innovation (rejecting a key point made by defenders of the drug lobby-friendly version of the legislation).
Brown’s office has spoken with activists like the AMSA (American Medical Students Assn.) about the bill and supports their efforts. They think that the best way to change minds in the Senate and help get the support necessary for passage is to have people relying on these drugs make a direct appeal. “They should share their stories and their medical bills,” the spokesman said.
This is part of a larger fight between liberal lawmakers and the pharmaceutical lobby, which made a deal with the White House and the Senate Finance Committee to limit their exposure in the health care bill and create huge profit centers like with the exclusivity arrangements on biologics. “In Washington, it seems like we always win the arguments, but Big Pharma wins the votes,” said the spokesman. “We want to win the argument and the vote this time.”