Senate Okays PDUFA
In a 93-to-1 vote, the U.S. Senate has approved a bill re-authorizing the U.S. Food and Drug Administration (FDA) to collect fees from drug companies to review investigational new drugs. The bill would also require that all phase II and later stage trials for both drugs and devices be listed on the government’s web site, www.clinicaltrials.gov.
Currently, the listing of trials beyond those for serious and life-threatening conditions is voluntary from a regulatory perspective. In addition to listings, the bill requires trial results to be added to the database after a product has been approved for marketing. The trial results will be provided by the FDA, the National Institutes of Health and peer reviewed journals. Sponsors who violate the new laws will be subject to monetary penalties.
The Prescription Drug User Fee Act (PDUFA), which was originally enacted in 1992 and was set to expire on Sept. 30, increases the amount collected through PDUFA by $138 million a year. The bill was sponsored by Sen. Edward Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee and Sen. Michael Enzi, R-Wyoming, a ranking member of the Senate Health, Education, Labor and Pensions Committee.
Although the bill would mean higher costs per drug submissions and force transparency on the pharmaceutical industry, it had the support of its largest lobbing group. The Pharmaceutical Research and Manufacturers of America’s (PhRMA) president and chief executive officer, Billy Tauzin, said in a statement:
“Swift reauthorization of the Prescription Drug User Fee Act (PDUFA) is essential to ensure that the Food and Drug Administration (FDA) has the resources necessary to protect and promote the public health. To this end, PhRMA applauds the Senate’s quick passage of the PDUFA legislation.”