Correspondence

Evaluating Drugs after Their Approval for Clinical Use

N Engl J Med 1994; 330:1394-1395May 12, 1994

Article

To the Editor:

Ray et al. (Dec. 30 issue)1 are to be complimented on their arguments in favor of changing the way we evaluate drugs after they have been approved for clinical use. As clinical pharmacologists, we strongly endorse their proposals for more research in this area and for a national center for the evaluation of new drugs. Independently, we arrived at similar conclusions and have proposed the creation of centers for education and research in therapeutics2. The concept of an independently funded center that could conduct research on drugs is not new. An important opportunity was lost in 1977, when the 95th Congress failed to pass legislation proposed by Senator Edward Kennedy that would have created a national center for clinical pharmacology. The time to pass such legislation has come.

There is no substitute for independently funded research in the areas of generic drugs and comparative forms of therapy, since, as Ray et al. point out, the pharmaceutical industry has no incentive to do such research. Representative Ron Wyden has proposed granting extended patent life for new drugs to companies that do perform comparative research, but it would be far less expensive to conduct these studies independently than to pay for the added cost of extended patent life.

If we do not develop independent ways of funding such research, we risk embarking on a perilous voyage with inadequate information to guide decision makers, who will include all health care professionals and organizations from nurse practitioners to practicing physicians and health care conglomerates. The Food and Drug Administration (FDA) does not carry out this critical research at the moment, and that agency is not empowered to require it of the pharmaceutical industry. More important, when the FDA is aware of critical comparative information, it has no mandate to make public anything except substantial health hazards and cannot carry out independent educational programs for the key providers involved.

We believe that the research proposed by Ray et al. must be combined with an independent educational program that will give professionals and the public the information they need to use drugs safely and effectively. Federally funded centers for education and research in therapeutics could provide both the necessary data and the mechanism to bring this information to all health care professionals and the public.

Raymond L. Woosley, M.D., Ph.D.
David A. Flockhart, M.D., Ph.D.
Georgetown University Medical Center, Washington, DC 20007

2 References

1. 1

   Ray WA, Griffin MR, Avorn J. Evaluating drugs after their approval for clinical use. N Engl J Med 1993;329:2029-2032
   Full Text | Web of Science | Medline

2. 2

   Woosley RL. Centers for education and research in therapeutics. Clin Pharmacol Ther 1994;55:249-255
   CrossRef | Web of Science | Medline

Author/Editor Response

The authors reply:

To the Editor: We appreciate the thoughtful comments of Drs. Woosley and Flockhart, who reinforce our arguments that the present system of drug development and regulation often fails to provide the data needed for clinical and policy decisions. They propose a network of academically based research centers for this function. We would like to reemphasize that our proposal placed the primary burden of providing such data on the pharmaceutical industry by linking reimbursement for a drug more closely to evidence of its comparative efficacy, safety, and cost. Because the revenues from a new product would depend on its relative merits, this procedure also would favorably influence the entire drug-development process, from the choice of compounds for evaluation (there would be little incentive for “me too” drugs unless they were cheaper) to the design of phase 3 trials (there would be encouragement for the inclusion of more nonplacebo drugs in comparisons and analyses of economic outcomes). In the multipayer environment of the United States, a center providing objective drug evaluations to payers would be the best vehicle for linking reimbursement to data. Pluralistic funding would help to ensure the center's viability and independence.

Woosley and Flockhart also suggest that academic centers address the corollary problem of informing clinicians about new data and ensuring that this new information leads to appropriate changes in practice. We briefly mentioned other approaches to this problem, including academic detailing, computerized feedback, practice guidelines, formularies, and drug-utilization review. Many of these techniques will become widely used as the role of third-party payers expands. The value of centers of the type proposed, in comparison with these other alternatives, needs to be clearly articulated.

We concur that incipient changes in health care financing and delivery provide a rare opportunity to reexamine how drugs are evaluated and prescribed. Implementation of reforms of the type proposed by us and by Woosley and Flockhart could materially improve both the clinical and the economic outcomes of pharmacotherapy.

Wayne A. Ray, Ph.D.
Marie R. Griffin, M.D., M.P.H.
Vanderbilt University School of Medicine, Nashville, TN 37232

Jerry Avorn, M.D.
Harvard Medical School, Boston, MA 02115