WASHINGTON _ As the final days of the 104th Congress wind toan end, it becomes increasingly likely that its efforts to reform theFDA will die on Oct. 4. The issue is alive and kicking for industryleaders, however.
"We aren't likely to see any progress in the next four and one-halfdays, but the wheels have significant momentum," said CarlFeldbaum, president of the Biotechnology Industry Organization(BIO). "Don't be surprised if at the beginning of the 105th CongressBIO has a bill ready to go."
This year, Sen. Nancy Kassebaum (R-Kan.) and Rep. Richard Burr(R-N.C.) each sponsored reform measures aimed at speeding theprocess of FDA approval and reducing the costs of drugdevelopment. However, the bills became mired down in disputes overprivatization, expedited approval based upon foreign approval anddissemination of scientific information about off-label uses of FDAapproved drugs. (See BioWorld Today, Aug. 6, 1996, p. 1.)
"Most points of contention were measures that we didn't see asessential," Feldbaum told BioWorld Today. "Having expeditedapproval and dissemination of information would have been nice, butthey weren't worth stopping the train. And we never called forprivatization of the process."
BIO supports efforts to guarantee that the FDA will respond to drugsponsors within 30 days of submitting a drug for approval (a measuremaking all written decisions binding) and modernization of lawsregulating biologics.
As Feldbaum sees it, the process of FDA reform is "only justbeginning." On Thursday, representatives from BIO and thePharmaceutical Research and Manufacturers of America will meetwith FDA officials to start negotiating the reauthorization of user feeswhich is set to run out this fall. "It is only natural and appropriate thatwe discuss streamlining drug approval in the process of negotiatinguser fees," Feldbaum said.
Feldbaum said he remains hopeful that dialogue with the FDA willcontinue to produce agreement on the streamlining process that canbe codified into law. "We have a lot in common," said Feldbaum."We both want a streamlined process that doesn't lower approvalstandards." n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.