By Lisa Seachrist
The first crack at FDA reform in the 105th Congress will be introduced in the Senate sometime in May if Senate Labor and Human Resources Chair Jim Jeffords (R-Vt.) keeps to his intended schedule.
At a committee hearing where Acting FDA Commissioner Michael Friedman testified about the progress the agency has made in streamlining procedures, Jeffords told members of his committee he intended to introduce a reform bill that would encompass both reauthorization of the Prescription Drug User Fee Act (PDUFA) of 1992 and global FDA reform.
"I feel strongly that we ought to be doing a reform bill this year," Jeffords said. "And I intend to use the importance of getting PDUFA reauthorization by September 30 to provide the right tensions to get reform moving."
In opening statements, several committee members expressed their displeasure with the Clinton administration's fiscal year 1998 budget, which proposes to use money raised as user fees to offset an eight percent decrease in the agency's appropriations level.
"I am strongly opposed to using PDUFA as a vehicle for deficit reduction," Sen. Edward Kennedy (D-Mass.) said. "I think it was a considerable mistake, and I let the administration know that."
Under PDUFA, the biotechnology and pharmaceutical industries pay fees to place the agency under review deadline. As a result, the agency has hired nearly 600 more reviewers and decreased average review times. That act will expire at the end of September.
Because the user fees have been essential to speedier drug approvals, Kennedy urged the committee to pass a "clean" PDUFA reauthorization bill to ensure there would be no gaps in the program.
Friedman agreed with Kennedy, noting that "a gap in PDUFA would be disastrous for the public health. Drugs would still be reviewed with the same rigor, but it would slow approvals and keep important drugs from the American public."
While noting the importance of PDUFA reauthorization, Jeffords said, "I know you want a clean PDUFA, but I also know that it is the biggest incentive that I have to get you to change."
Attention To Child Health Urged
In other comments, Sen. Chrisopher Dodd (D-Conn.) said that he and Sen. Michael DeWine (R-Ohio) intended to introduce a bill that would provide incentives for companies to do pediatric research.
"Americans get up in the morning and use [pharmaceuticals] all day long and that is done with a confidence that in no small measure is the work of you and your predecessors," Dodd said. "However, one out of every five drugs are labeled for pediatric use and it is important that physicians know the appropriate dose to give to children."
Sen. Susan Collins (R-Maine) asked Friedman whether a risk adverse culture, for whom the overwhelming responsibility of making life and death decisions prevents decisions from ever being made, was slowing the drug approval process.
"Changes in our culture are less mathematically quantifiable," Friedman said. "But we are eager to eliminate unnecessary regulatory burdens and balance our need as an agency for compliance and facilitation."
Friedman noted throughout his testimony that the agency was eager and prepared for the changes that would make it more effective, noting that the agency has opened up dialogue with its regulated industries through avenues like PDUFA and pending FDA reform.
Several committee members, however, noted that while drug approval times have dropped, drug development time has increased dramatically.
"It is my hope that we can introduce new performance measures for the FDA addressing the drug development phase as a part of the reauthorization of PDUFA."
Jeffords intends to have another hearing entertaining the industries regulated by the FDA sometime in April. *