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House Oversight and Reform Committee Chairman Henry Waxman (D-Calif.) has taken an interest in the debate over how the FDA can approve follow-on biologics, holding a hearing on the issue featuring scientists from the pharmaceutical industry.
Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.
As Congress considers reauthorization of two programs that encourage companies to gather information on drugs’ effects on children, witnesses at a recent hearing suggested improvements and debated the six months of exclusivity granted to manufacturers under one of the acts.
Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.
Witnesses at a Senate hearing debated the costs and risks of allowing imported pharmaceuticals, with some saying a proposed bill would cause “a flood” of dangerous counterfeit drugs into the country and others claiming it would improve safety.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) have asked FDA Commissioner Andrew von Eschenbach to respond to an independent review that called the agency’s postmarketing surveillance system “dysfunctional.”
Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.) have introduced legislation they say goes further to strengthen the FDA’s drug safety review processes than the bill’s counterpart in the Senate.
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.
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.