FOLLOW-ON BIOLOGIC PATHWAY BILL MAY BE ATTACHED TO PDUFA
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 this week.
At a press conference, House Committee on Oversight and Government Reform Chairman Henry Waxman (D-Calif.) and Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.) unveiled the bill to give the FDA the authority to approve lower-cost copies of biopharmaceuticals. It establishes a statutory pathway for the FDA to approve comparable biologic license applications by giving the agency a way to measure the comparability of a biogeneric drug to its reference product without having to conduct costly and duplicative clinical trials. Because Congress adjourned last year without acting on the legislation, it has to be reintroduced to be considered.
Waxman revived the bill to change what he said is the monopoly status drug companies have over the biologic sector of the market due to a lack of generic competition. "There is no generic competition for one of the fastest-growing areas of the pharmaceutical industry, which is biopharmaceuticals," Waxman said.
Some biologic drugs, such as those used to treat cancer and diabetes, can cost as much as $100,000 a year, Waxman said, adding that these drugs currently have no approved biogeneric equivalent.
While the FDA has, in the past, approved generic versions of relatively simple biotech drugs, it has yet to approve a generic copy of a more complex biologic, according to Waxman. "The time has come for creating a pathway for approving these drugs."
In response to opponents who raised safety concerns due to the scientific complexities of approving a biologic drug, Schumer said the bill would not affect relevant drug safety laws. "We don't touch drug safety laws, we only touch the patent laws," he said.