WASHINGTON _ Several members of the National Task Force onAIDS Drug Development on Thursday scolded the drug andbiotechnology industry for claiming that FDA reform was necessaryto re-energize lagging biotech drug development.
The criticisms were lodged at the first of a two-day meeting of thetask force which was finalizing recommendations to the Secretary ofHealth and Human Services on ways to give biotech drug companiesmore incentives to invest in AIDS drug research and development.
The task force proposals include incentives involving tax credits,extending patent terms, streamlining regulations and ensuring accessthrough appropriate reimbursement. Lack of credibility in the biotechindustry's arguments, however, was the most contentious pointraised.
Task force member Peter Staley, who represents the TreatmentAction Group, in New York, criticized the industry for failing todifferentiate itself from more radical proposals to reform FDA thatwould eliminate the agency's independence and terminate thestandards of safety and efficacy for all drugs.
"You have infuriated the AIDS community by not denouncingextreme proposals to reform drug approvals. You have chosen whichbeds you are going to lie in and it is not conducive to a constructivedialog." Staley said.
The public scolding was not what the industry had sought. "Wewould like a public statement in support of FDA legislation," ChuckLudlam, vice president for government relations for theBiotechnology Industry Organization, told the task force. "Thatwould be extremely helpful in moving the process along," he said
BIO and other medical products lobbies so far this year have notbeen successful in convincing Congress to act with dispatch on FDAreform legislation.
Tim Westmoreland, senior policy fellow with GeorgetownUniversity's Federal Legislation Clinic, who was an invitedparticipant at the task force meeting, said that "the industry needs todisown immoderate proposals" and needs to tell more conservativesin Congress that some of their proposals go too far.
FDA Commissioner David Kessler said the debate was a matter ofwhether FDA's drug approval process could be repaired throughregulation or that legislation was necessary to make morefundamental changes.
"What I don't understand is how legislation will affect a decision onwhat is the appropriate end point for a clinical trial," Kessler said."And I don't understand how delegating review functions to aninstitutional review board would speed the drug approval process.The issue is a lot more complicated than the industry has portrayed."
Arthur Ammann, a member of the task force and physician whodirects an AIDS treatment project, said the biotech industry needs toshoulder some of the blame itself for the industry's poor showing inthe capital markets. Biotech firms "need to screen possible drugformulations before they go into development," Amman said.
Citing statistics that 80 percent of biotech drugs fail development,Ammann said the industry "cannot blame the agency" entirely for itslack of drugs in Phase III trials.
The task force will consider FDA reform today. Also topping theagenda are protease inhibitors and improved coordination betweenthe FDA and the National Institutes of Health on gene therapy.
Editor's note: BioWorld Today's next issue will provide a completeoverview of how biotech firms will be affected by the task force'srecommendations. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.