WASHINGTON _ The National Task Force on AIDS DrugDevelopment, created two year ago to advise the federal healthestablishment on how to manage the nation's shrinking portfolio ofAIDS therapies, appears to have lost the support of key members ofthe Clinton administration.
In an impassioned discussion Friday on whether the AIDS task forceshould continue past the end of its charter in October, AssistantSecretary for Health Philip Lee, FDA Commissioner David Kessler,and National Institutes of Health Director Harold Varmus allexpressed frustration at the pace and content of the recommendationsmade by the task force.
Their frustration was shared by several members of the task force. "Intwo years we have nothing to point to," said panel member PeterStaley, who represents the New York City-based Treatment ActionGroup. "We had inadequate staff, a minuscule budget, a slowschedule and not enough support from David Kessler, Phil Lee andHarold Varmus."
Lee, who admitted he was frustrated with the lack of progress,pledged to meet with Health and Human Services Secretary DonnaShalala in the fall to discuss the task force's accomplishments andwhether it should continue in its present form or devolve intoworking groups.
In its two-day meeting to hammer out a number of recommendationsfor Shalala's review, the panel took of number of actions sought bythe biotech industry. Many of them are in concert with the industry'scurrent lobbying agenda on Capitol Hill.
"The task force's actions help create a climate that will lead to thedevelopment of more AIDS drugs," said task force member StephenCarter, senior vice president of Bristol-Myers Squibb Co., inPrinceton, N.J. "Right now it is not clear if the pharmaceutical andbiotech manufacturers are committed to AIDS drug development. Ifthe department acts favorably on the recommendations,manufacturers will have some incentives," Carter told BioWorldToday.
Chuck Ludlam, vice president for government relations for theBiotechnology Industry Organization, termed the actions "useful andpositive" even though he had hoped for a positive statement from thetask force endorsing the need for legislation to reform the FDA.
Following is a summary of recommendations approved by the taskforce on June 29 and 30:
* Patent Term Extension. Despite concerns from some AIDScommunity activists that manufacturers were not moving fast enoughto bring their products to market, the task force agreed that theClinton administration should consider supporting amendments to theHatch-Waxman Patent Term Restoration Act so that biotech andpharmaceutical products do not lose patent term protection due todelays at the FDA. Ludlam said that lengthening patent protectionshould provide an incentive to support additional research on a drugand to extend its claims to other indications.
* Tax Credit Proposals. Some members of the task force, includingFDA's Kessler, said the task force opened a Pandora's box byattempting to make drugs used to treat AIDS and AIDS-relatedconditions classified as orphan drugs, enabling their manufacturers toreap certain federal financial incentives.
"By giving AIDS drugs orphan drug status, you create a tensionamong advocacy groups of other major life threatening diseases,"Kessler said. Panel member Daniel Hoth, senior vice president ofCell Genesys Inc, Foster City, Calif., said the recommendationreflected the fact that AIDS drugs are market failures. Approved waslanguage urging that the administration propose legislation to makethe Orphan Drug Tax Credit permanent and restructure it so that itcan be carried forward with no tax liability.
They also said the administration should propose legislation tosupport a 50 percent tax credit for all AIDS-related clinical researchspending. The current 20 percent tax credit expired on Dec. 31, 1994.Invited participant Tim Westmoreland, senior fellow at GeorgetownUniversity's Federal Legislation Clinic in Washington, wasconcerned about the political viability of this proposal because of itshigh price tag.
Also approved was language directing the administration to propose a50 percent tax credit for all AIDS-related research expendituresincurred following accelerated approval of a new AIDS drug.
* Pediatric AIDS Drugs. The panel enthusiastically recommendedthat the administration develop a package of proposals to give marketexclusivity to those manufacturers who develop pediatricformulations to current or new AIDS drugs. Even Kessler and Lee,who abstained from votes on questions involving the federalgovernment, lent their personal, enthusiastic support.
* FDA Reform Legislation. The committee declined to endorseindustry's request for a statement backing the need for FDA reformlegislation. (See BioWorld Today, June 30, p. 1.)
The task force ran into stiff opposition from Kessler when itconsidered a proposal that would allow a manufacturer to circulateadditional claims about a product "to bring the label and the packageinsert closer to actual clinical usage." Kessler repeated his oppositionto permitting manufacturers to use articles that he said are "notsurrogates for valid and reliable information."
Carter countered thatthe current clinical practice in cancer drugsbears no resemblance to the labeling approved by FDA. Kessleragreed that the agency could show more flexibly about approvingclaims for secondary uses of drugs and promised to evaluate aprocess to do so.
The task force also voted to urge FDA to collaborate with industry toimprove early access programs for AIDS patients to obtain access tonew therapies.
Kessler did not endorse a proposal approved by the taskrecommending that FDA provide written confirmation that onepivotal trail can be considered as the basis for approval for break-through drugs.
* Viral Load Diagnostics. While the panel reiterated the need for anapproved viral load diagnostic test and urged the FDA to expeditetheir review, Kathryn Zoon, director of the FDA's Center forBiologics Evaluation and Research, said the agency has not yetreceived a single application for this test but would sit down withindustry and talk about what regulatory requirements must be met.
* Gene Therapy. Several task force members reiterated theirfrustration with the failure by the FDA and National Institutes ofHealth (NIH) to iron out an agreement that ends the duplication ofregulation of gene therapy protocols. "There is no integratedapproach," complained Hoth. Staley said NIH's oversight was areaction to the "ethical concerns of the religious right who arescrewing up AIDS research."
* Reimbursement For AIDS Care: The task force adopted acomplicated set of proposals that urged broad coverage of AIDSdrugs and treatments. Their political viability was questioned by atleast one participant who noted that these proposals were not realisticin light of Congressional conservatives' determination to roll backregulation and reduce federal spending on Medicare and Medicaid. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.