PhRMA Opposes Changes in Prescription Drug User Fee Act
Pharmaceutical Research and Manufacturers of America President Alan Holmer said last Friday that negotiations with the FDA over renewal of the Prescription Drug User Fee Act of 1992, which expires in September, "have not gone as smoothly as last time," CongressDaily reports (Fulton, CongressDaily, 1/28). Under the law, last renewed in 1997, the FDA charges drug makers a fee in exchange for an expedited review process. The law allowed the FDA to reduce the average review time for new drugs to less than one year in 1999, from about two years in 1990. The fees account for about 12% of the agency's $1.3 billion budget (American Health Line, 12/10/01). PhRMA hopes to renew the law without the addition of some "controversial ... reforms" that would use the fees for "activities outside of application review," including "beefing up [the FDA's] adverse event reporting database," improving "post-market surveillance" and "increasing [the agency's] vigilance" over direct-to-consumer advertisements sponsored by drug companies. According to Russ Bantham of PhRMA, the proposed reforms "were not intended as part of the original law" and could lead to "conflicts of interest." He said, "Citizens need to have total confidence in the FDA's enforcement role." However, he said that the proposed reforms "are part of the discussion" between PhRMA and the FDA. Several Democrats, including Rep. Sherrod Brown (D-Ohio), have "expressed interest" in the proposed reforms, CongressDaily reports. The House Energy and Commerce Subcommittee on Health plans to begin hearings on the legislation "soon," a Republican aide said.
Holmer also said on Friday that the absence of an FDA commissioner has made "action on a number of fronts" more "difficult" for PhRMA. "For our individual companies, there have been significant challenges without leadership at the top," he said. However, PhRMA has "declined to offer support for any particular" candidate for the position, CongressDaily reports. Holmer also said that this year, PhRMA plans to "pressure" Congress to pass a Medicare prescription drug benefit that would "rely on the free market" and would allow patients to have access to brand-name prescription drugs. In addition, Holmer said that the pharmaceutical industry will offer seniors pharmacy discount cards, lobby to protect drug maker's intellectual property rights, increase access to prescription drugs and help the government with anti-bioterrorism efforts (CongressDaily, 1/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.