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A forceful “culture of approval” and attempts to muffle scientific dissent among agency reviewers have created significant problems in the FDA’s drug review process, witnesses at a House subcommittee hearing testified.
Days before the start of a hearing challenging India’s drug patent laws, House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) called for an end to the challenge by Novartis, saying that a victory for the company could limit access to low-cost generic drugs.
Members of the Senate Judiciary Committee unanimously approved Sen. Herb Kohl’s (D-Wis.) reverse-payment legislation — bringing the prohibition of that practice a step closer to becoming law.
The Prescription Drug User Fee Act (PDUFA) pressures the FDA to review drugs on too-tight deadlines and encourages the agency to put the public’s interest second to the industry’s, witnesses at a House subcommittee hearing said.
The reintroduced “Access to Life-Saving Medicine Act,” a bill that would establish a clear and effective pathway for the FDA to approve generic copies of biologic drugs, may be attached to the Prescription Drug User Fee Act (PDUFA), congressional lawmakers said yesterday.
A forceful “culture of approval” and attempts to muffle scientific dissent among agency reviewers have created significant problems in the FDA’s drug review process, witnesses at a House subcommittee hearing testified.
Government healthcare programs must require more price transparency and better reporting to stop pharmaceutical companies from overcharging them for medications, according to experts and activists testifying at a House committee hearing last week.
President Bush’s proposed 2008 budget includes funding to increase certain functions of HHS, but some lawmakers criticized cuts to Medicare and Medicaid.
Rep. Rosa DeLauro (D-Conn.), a frequent critic of the FDA’s drug safety system, has seized on a recent agency report as evidence that the agency’s postmarketing efforts are failing, but industry and activists are skeptical of her reasoning.