Pharmacy & Therapeutics - April 2008 - (Page 249) HEALTH CARE AND LAW continued from page 220 Clinical Focus: Skin Infections, Hemostasis continued from page 224 them. Without sufficient oversight, the opportunities for abuse are too great. ARGUMENTS AGAINST STRICT LIMITS ON PROMOTION Unfor tunately, the FDA’s approval process for new indications is very slow and expensive. The clinical trials that are needed can take several years and can cost hundreds of millions of dollars. After the FDA receives the data, it can take many months or even years for a decision. All the while, the patent on the drug is nearing expiration, at which point the manufacturer realizes greatly diminished financial rewards for its efforts. The cumbersome nature of FDA approvals is an important reason that such a large percentage of prescription drugs are presently used for off-label indications, many with life-saving effects. For example, many oncology drugs that are approved to treat one kind of cancer have been used for another type, and many drugs approved for use only in adults are also used in children. In some medical specialties, therapeutic options would be severely limited without off-label prescribing. FDA resources to conduct such oversight must be increased. Even though there are many competing demands for FDA funds, faster reviews are not feasible without them. Finally, rules on patents should recognize the time pressures involved in filing for approval of new indications during the term of the drug’s patent protection. Each of these elements raises significant issues, but without reforms of a fundamental nature, the incentives that drive the current dynamics of off-label marketing are unlikely to change. Dr. Chapman concluded that bThrombin and rThrombin had comparable efficacy when used in conjunction with a gelatin sponge as a topical adjunct for surgical hemostasis. Safety profiles were similar for the two patient groups, but the rate of antigenicity associated with rThrombin was notably decreased. In an interview, he replied that the risk of infection with carefully screened blood bank products was “quite small, but not zero.” He explained: If we now have recombinant proteins that allow us not to have to utilize either bovine, other animal, or human products with potential for infection—with all other factors being equal, the recombinant is likely to be the safer choice. CONCLUSION Drug companies will always seek to extend the markets for their products, and regulators will always be concerned that the promotion of these products be truthful. The challenge is to strike a balance that best protects patients. To this end, marketing of off-label uses should not be considered in isolation or simply as a matter of which journal reprints can be sent to whom. It is part of the broader life cycle of drugs, and policies regarding off-label uses should consider that larger process. Dr. Chapman also noted that other recombinant hemostatic products have had a “great track record and great acceptance.” REFERENCE 1. Davis SL, McKinnon PS, Hall LM, et al. Daptomycin versus vancomycin for complicated skin and skin structure infections: Clinical and economic outcomes. Pharmacotherapy 2007;27(12):1611–1618. 2. Chapman W. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg 205(2):256–265. I ISSUES FOR POLICY FOCUS Ultimately, the focus for public policy should center on ways to encourage companies to submit new indications for FDA review. Even the court in the Washington Legal Foundation case, with its skeptical attitude toward regulation of commercial speech, recognized this as a legitimate government interest. If logistical impediments to approval can be controlled, this would be the best way to differentiate effective new uses for drugs from unsubstantiated claims. It is in regard to promoting FDA review that resolution of this issue will affect broader pharmaceutical policy concerns. To facilitate the approval process, three key elements must be considered. First, the lengthy period for reviewing additional indications should be shortened to reduce the current disincentive to filing. To accomplish this, the level of REFERENCES 1. Barlas S. Off-label drug promotion now on the table. P&T 2008;33(2):73–74. 2. FDA. Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices. Docket No. FDA-2008-D-0053, OC 2007268, February 15, 2008. Available at: http://69.20.19.211/oc/op/ goodreprint.html. 3. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med 2006;166: 1021–1026. 4. 21 U.S.C. §360aa, §551. 5. 13 F.Supp. 2d 51 (D.D.C. 1998). 6. 21 C.F.R. Part 99 (Code of Federal Regulations). 7. Harris G. F.D.A. seeks to broaden range of use for drugs. The New York Times, February 16, 2008, p. C1. 8. Berenson A. Indictment of doctor tests drug marketing rules. The New York Times, July 22, 2006, p. A1. I Vol. 33 No. 4 • April 2008 • P&T® 249 http://69.20.19.211/oc/op/goodreprint.html http://69.20.19.211/oc/op/goodreprint.html
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