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Executive Summary

MEDICAID OFF-LABEL DRUG COVERAGE will not reduce physician liability for prescribing drugs for unapproved uses, attorney Gary Green of the Philadelphia law firm Sidkoff, Pincus & Green predicted Nov. 12 at a Scott-Levin Associates symposium on pharmaceutical marketing. Green speculated that a physician prescribing a drug for an unapproved use is "not going to find any solace from the standpoint of protection from liability" even if the use is listed in one of the three compendia sanctioned by the new Medicaid legislation: USP Drug Information, American Medical Association Drug Evaluations, or American Hospital Formulary Service Drug Information. Green, who specializes in business and commercial law and complex litigation, described the line of attack he would take against a physician who had used one of the compendia: "There's one pristine standard. That's FDA. That's the hardest evaluation program to satisfy." For the other sources, Green argued, "the testing facilities are not uniform, are not precise, and there's very poor oversight. And much of the process outside of FDA is so highly politicized that it can be attacked by someone who takes the drug for a use that is not approved by FDA and suffers an adverse reaction." Green said he had researched "15 instances where doctors were sued for prescribing drugs not approved by FDA," and found that in 14 of the cases "the doctors didn't have a chance." The doctors were at a disadvantage, the attorney noted, even when "the expert testimony that the plaintiff put on was of the lowest grade." While acknowledging that the number of such cases "seems to be low," Green predicted that such liability suits may increase as pharmaceutical company advertising becomes more aggressive. "More and more the argument is going to be accepted that FDA is too slow in moving amendments to NDAs, so [doctors] have the right" to turn to other sources, Green asserted. At the same time, according to Green, the standards for malpractice have not changed -- physicians prescribing drugs for off-label uses remain at risk in litigation. Green suggested that pharmaceutical companies who directly or indirectly promote off-label uses of their products through focus groups or publicity campaigns risk "massive defection from your company by doctors who feel that they have been misled." Green noted the conflict between the new Medicaid coverage of off-label uses and FDA's position: "Don't confuse what Medicaid is doing with what FDA is doing . . . No one really cares when you get to Medicaid about the health of the people, they care about how are we going to afford it. The FDA is not involved in any of the Medicaid situations. You may get reimbursed, at the same time FDA may be screaming in another part of the government: 'You're reimbursing people for killing other patients.'



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