OR WAIT 15 SECS
Jill Wechsler is Pharm Exec's Washington Corespondent
Washington, DC-A new advisory committee appointed by HHS secretary Tommy Thompson will scrutinize agency policies to identify ways to improve programs and regulations.
Washington, DC-A new advisory committee appointed by HHS secretary Tommy Thompson will scrutinize agency policies to identify ways to improve programs and regulations. Mayo Clinic cardiologist Douglas Wood heads the 27-member panel, which includes representatives of health plans, hospitals, providers, and Genentech chief medical officer Susan Desmond-Hellman.
The group will focus on Medicare and Medicaid as well as FDA activities. At the first meeting, FDA senior associate commissioner Bill Hubbard outlined several key programs in need of "reinvention":
Field inspections. The agency meets a two-year inspection requirement for less than 10 percent of manufacturers and needs to find "innovative ways" to revise the process or risk losing credibility.
Import policies. An "explosion in globalization" has expanded the number of imports, but with only 150 inspectors, the agency can review less than 1 percent of them.
Risk management. FDA plans to release a white paper on risk management this spring to initiate reform in this area.
Information technology. The agency needs policies to enable electronic submission of applications and plans to increase barcoding of medical devices and pharmaceuticals.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER) described the Prescription Drug User Fee program (PDUFA) as a model for how regulatory initiatives can solve administrative problems-in this case, speeding up FDA's approval process for new medical products and improving Americans' access to new therapies. PDUFA has also reduced clinical development time and has fostered significant management and cultural changes at FDA. PDUFA's success will be debated more as industry and FDA negotiate the ground rules for renewing it this fall. FDA says it needs more fee revenues to expand postapproval monitoring, but it wants less micro-management by manufacturers. Pharma companies oppose expanding fees to cover a broader array of FDA programs and claim that clear goals are critical to making the program work.
Advisory committee members are holding public meetings around the country to uncover regulatory issues important to patients and the medical community that could be revised, revoked, or more broadly implemented. The committee is supposed to make its recommendations by this fall, although Thompson urged members to bring any good ideas to him earlier, especially problems that he "can fix personally."