SENATE DEMOCRATS WILL LIKELY TARGET GENERICS, DRUG SAFETY, PATENT PROTECTIONS
With the Democrats taking control of the Senate, the healthcare agenda will likely focus on increasing the availability of generics in the market, improved drug safety and the role of trade policy in protecting domestic pharmaceuticals, according to industry observers.
Based on seniority in key Senate committees, it appears that Sens. Edward Kennedy (D-Mass.), Max Baucus (D-Mont.), Patrick Leahy (D-Vt.) and Herb Kohl (D-Wis.) will shape healthcare policy during the 110th Congress. These lawmakers are all the ranking members in committees that have jurisdiction over healthcare and are in line to take over as chairmen.
Kennedy will likely chair the Senate Health, Education, Labor and Pensions Committee, with Baucus chairing the Finance Committee and Leahy running the Senate Judiciary Committee. Kohl is expected to chair the appropriations subcommittee that funds the FDA.
Various experts say that the Senate will focus on generics in the next session as part of an effort to lower drug prices. "The cost of drugs is going to be a key issue in the next Congress, and the role of generics is going to be a big part of it," David Adams, chair of the law firm Venable's FDA Practice Group and former director of the policy staff in the FDA's Office of the Commissioner, said.
G. Steven Burrill, CEO of Burrill & Co., agreed, calling the new Congress "pro-generics." Not only is the new Democratic leadership likely to push for more generics, but there are also many special interests lobbying for that cause as well, Marc Scheineson, a partner at the law firm Alston & Bird and former FDA associate commissioner for legislative affairs, said. These groups include insurers, benefit managers, pharmacies and large employers, such as Ford, General Motors and Eastman Kodak, he added.
Leahy has taken an interest in the generic drug industry, cosponsoring legislation that would both help and hinder that sector. On one hand, the senator helped sponsor, S.3818, which would make it more difficult for generic manufacturers to prove that brand companies deceived regulators. The senator had also sought limits on the time available for generic companies to challenge patents.
But Leahy has also collaborated with Kohl on a number of bills that would ease the introduction of generics onto the market. The senators recently introduced legislation that would limit what they call abuses of the FDA's citizen petition process used to delay generic drug approvals.