WASHINGTON_The FDA should be able to award ineffect a "Good Housekeeping" seal of approval to certifythat drug cost-effectiveness studies meet generallyaccepted guidelines, said two experts.

Bryan Luce, CEO of MEDTAP International consultancyin Arlington, Va., and Alan Hillman, director of theLeonard Davis Institute of Health Economics at theUniversity of Pennsylvania in Philadelphia, made therecommendations at an FDA public hearing. The FDAconvened the public forum to air differing views onwhether the agency should regulate pharmacoeconomicstudies or more simply facilitate the marketplace for cost-effectiveness studies.

While their recommendations fall short of the FDAputting cost effectiveness claims on the same footing asother drug company promotional materials, Luce andHillman see a role for the agency. They recommendedthat the FDA establish a panel of experts to reviewpharmacoeconomic claims and to pass down judgmentsabout whether a study does nor does not conform togenerally accepted guidelines.

The guidelines referred to by Luce and Hillman wereones they helped to develop. The guidelines wereadvanced at the University of Pennsylvania with thefinancial backing of major pharmaceutical and biotechdrug makers and were published in the July 1 issue ofAnnals of Internal Medicine. (See BioWorld Today,October 16, 1995, p.1).

The FDA is considering what kind of involvement tostake out in the rapidly growing field of cost-effectiveness research. Some FDA officials consider cost-effectiveness studies as promotional materials and shouldbe held to the same standard as advertising and labeling(See BioWorld Today, March 27, 1995, p. 1).

CEO Urges Caution

One biotech company sees both merits and drawbacks toFDA involvement. Thomas Fraser, president and CEO ofCharlestown, Mass.-based Diacrin, Inc., said he doubtedthat the FDA should assume a regulatory role "until wehave the evidence that companies are not followingestablished guidelines."

Fraser told BioWorld Today, "I'm hesitant aboutinstalling another layer of bureaucracy."

However, Fraser recognized that the FDA "seal ofapproval" would empower a biotech drug maker whennegotiating with a managed care organization (MCO) toincorporate a biotech therapy into its standards of care. "Ifthe FDA recognized a cost-effectiveness study, then itwould be hard for an MCO to ignore it," said Fraser.

Fraser predicted that patient advocates will have a role indetermining what drugs are permitted to be used bymanged care physicians. "If a patient advocacy groupfeels they are getting squeezed out of a new therapy thatwill benefit them, they will put pressure on the MCO toincorporate the therapy," said Fraser. "These groups donot yet exist in a powerful form but when they are at thebargaining table they will drive many decisions inMCOs," he said.

One drug maker urged the FDA to `even the playingfield' so that drug manufacturers would compete on thesame basis as other new technologies introduced intomedical practice. "Pharmaceuticals compete not onlywith other pharmaceuticals but with other health caretechnologies," said Jane Osterhaus, director ofpharmacoeconomic research for Glaxo Wellcome Inc., ofResearch Triangle Park, N.C.

Technology assessments range from the strict standardsimposed by the FDA for approval of drugs to "theevaluation of surgical procedures for which there arealmost no randomized clinical trials. The fact that otherinterventions do not have the same requirements forcommunication of information creates a lopsided playingfield putting some technologies at a distinctdisadvantage," she told the FDA public hearing.

Data Sharing Helpful

"The agency needs to change the regulatory environmentto facilitate a free exchange of information," Osterhaussaid. "These modifications would allow presentation ofbroader types of pharmacoeconomic data including thedissemination of peer-reviewed journal articles, whetheror not the information is outside of labeling."

Permitting manufacturers to distribute promotionalmaterials that have not been approved by the FDA is oneof the most controversial issues surrounding pendingFDA reform legislation (See BioWorld Today, June 2,1995 p. 1). While FDA Commissioner David Kessler hasbeen described as wanting to exert continuing FDAcontrol over what drug companies say about theirproducts in print or other media, several members ofCongress think the health care marketplace wouldregulate false and erroneous claims by manufacturers.

Osterhaus is concerned that the FDA would seek tohinder manufacturers' dissemination of information aboutthe "real life" uses of pharmaceutical products.

The need for data about "real life" uses of drugs asopposed to controlled clinical trials was echoed byseveral managed care executives. Richard Jay, apharmacist and vice president of Corporate Rx Servicesof Fountain Valley, Calif., told the FDA hearing that theissue is not "more or less data" but more importantly "thekinds of data and knowledge gleaned from the data."

Jay added, "Usually journal articles compare two drugswithin the same class of drugs. More valuable would be acomparison of drug therapy with change in lifestyle."

Few of the presenters at the FDA-sponsored publichearing supported expanding the agency's regulatorypowers to include pharmacoeconomic research. "There isneither the requisite scientific agreement nor the politicalwill needed to support an extension of FDA regulatorypowers to pharmacoeconomic research and relatedclaims," said Calvin Knowlton, president of the AmericanPharmaceutical Association, in Washington. "A private,nonprofit entity, without even the potential for exercise ofpolice power, may be in a better position to quicklyadvance the state of the art than any governmental effort."n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.