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t • • • The Journal of the Amencan Medlcal Assoaetan February 2, 1994 Pro-Free Enterprise Group Challenges FDA's Authority to Regulate Drug Companies' Speech THE US Food and Drug Administra- tion (FDA) has indefinitely postponed the publication of its long-awaited final policy statement on industry-supported scientific and educational activities. The FDA has delayed issuing its final guidelines-which were supposed to be published by the end of 1993-in order to answer a "civil petition" filed by a "pro-free enterprise" group that is chal- lenging the agency's legal authority to regulate the speech of pharmaceutical and medical device manufacturers. The Washington, DC-based group, called the Washington Legal Founda- tion, is asking the FDA to cease "vio- lating the First Amendment rights" of physicians and patients who have an ur- gent need for timely information about these products. The foundation's petition, filed on Oc- tober 22, asks the FDA "to withdraw its draft policy ["Draft Policy on Industry- Supported Scientific and Educational Activities," Federal Register. Novem- ber 27, 1992] and to refrain from taking any enforcement action against manu- facturers that sponsor scientific or edu- cational activities or distribute medical textbooks that discuss off-label uses of approved drugs. The petition also asks the FDA to "formally adopt a policy that recognizes the important role played by off-label uses of approved drugs and medical devices in the proper adminis- tration of health care in this country." The FDA's draft policy on industry- supported scientific and educational ac- tivities was developed to prevent manu- facturers from unduly influencing the content of continuing medical education (CME) programs (JAMA. 1991;266: 2947). Nevertheless, unless the FDA aban- dons this policy, the Washington Legal Foundation will take the agency to court, says its chief counsel, Richard Samp. The foundation, which describes it- self as "a pro-free enterprise public in- terest law and policy center with more than 100000 members and supporters nationwide," says it filed the petition not on behalf of the pharmaceutical in- dustry but "on behalf of doctors and medical patients who wish to receive information about off-label uses of FDA- approved drugs and medical devices." The foundation, says Samp, "devotes a substantial portion of its resources to defending the rights of individuals and businesses to go about their affairs with- 332 JAMA Feoruarv 2 1994-Vol 271 No 5 out undue interference from government regulators." The foundation claims that the FDA's "restrictions on dissemination of truth- ful information regarding lawful uses of FDA-approved drugs and medical de- vices violate the First Amendment rights of both providers and would-be recipients of such information, and that such restrictions are in excess of FDA's statutory authority (which is limited to regulation of labeling of drugs and medi- cal devices)." 'Endangers Uves' According to the petition, the FDA's conduct in recent years suggests that the agency "has a strong aversion to the dissemination of information regarding off-label uses of drugs and medical de- vices; that in its 'perfect world' [the] FDA would prohibit all such informa- tion flow." "The FDA has threatened severe sanctions against manufacturers who be- come actively involved in scientific and educational programs at which off-label uses of the manufacturer's drugs or medical devices are to be discussed," Samp says. The FDA's draft policy state- ment "imposes severe restrictions on manufacturer involvement in such pro- grams. The result is that many such programs are being canceled, and doc- tors are not receiving vital information about recognized off-label uses of FDA- approved drugs and medical devices." The petition states: "Manufacturers should not be subject to sanctions sim- ply because, in furtherance of their eco- nomic self-interest, they assist in the dissemination of truthful information re- garding unapproved uses for their prod- ucts. [The] FDA is authorized, of course, to prevent manufacturers from mis- branding their products by including un- approved uses on products labels; but FDA has stretched its 'labeling' author- ity far beyond anything contemplated by Congress in adopting the federal Food, Drug, and Cosmetic Act." "The FDA's violations of basic First Amendment rights are needlessly en- dangering the lives of countless Ameri- cans who depend on off-label use of FDA- approved drugs for their very survival," Samp says. "The great majority of recognized treatments of childhood cancers consist of administering FDA-approved drugs for off-label uses. But as a result of FDA's restrictions on publicizing such off-label uses, information regarding effective treatment often is delayed in reaching other physicians who are treating child- hood cancers." "The incidence of cancer among in- fants and children is very low compared with the incidence of cancer among adults," says the foundation's petition. "It is not economically feasible for a com- pany that has developed a cancer drug to undertake the extremely time-con- suming and expensive clinical trials nec- essary to obtain FDA approval for ad- ministering the drug to children. As a result, many drugs that reach the mar- ket based on demonstrated efficacy against adult cancers never acquire FDA-approved labeling for pediatric use. Nonetheless, such drugs are frequently found by pediatric oncologists to be highly effective against the cancers of children." Indeed, according to Donald R. Ben- nett, MD, PhD, director of the Ameri- can Medical Association's Division of Drugs and Toxicology, 40% to 50% of all drugs are prescribed for off-label uses. Sixty percent to 70% of drug regimens used in the treatment of cancer and 80% to 90% of pharmaceuticals used in pe- diatrics are for purposes not yet ap- proved by the FDA. Pharmaceutical Industry's View Speaking at the Fourth National Con- ference on CME Provider-Industry Col- laboration, held in Washington, DC, in October, Peter Bewley. JD, associate general counsel for Johnson & Johnson, New Brunswick, NJ, provided a view that appears to be shared by many in the pharmaceutical industry. That pharmaceutical companies do not use the First Amendment to defend themselves against the FDA should not encourage the FDA to disregard the First Amendment in formulating regu- latory policies, Bewley says. "The stakes are usually so high-companies often are threatened with seizure of millions of dollars of inventory-that most com- panies would rather settle than litigate." According to Bewley, "The basic ra- tionale for the First Amendment is that no one person or group has a lock on the truth. Truth is best sen•ed by open dis- cussion where the views of many can be considered.tested,and accepted or re- jected. Indeed, we should be most fear- Medical News & PerspecUves

4 S S • ful when the government tries to tell us what the truth is and attempts to pro- hibit us from talking about different pos- sible truths. "Health care reform requires a much more efficient mechanism for dissemi- nating scientific information," he say=_. "We must meet the information needs of the health care community as we move toward universal coverage and managed competition in health care delivery. "The constitution does not permit and health reform cannot endure allowing a single, small group of enforcement of- ficials'at the FDA to continue to inter- fere with the dissemination by manu- facturers of truthful information about advances in medical sciences. The FDA policy creates high, artificial, and un- necessary barriers to prompt dissemi- nation of this kind of information. We must get the FDA out of the loop." Be- wley says. FDA Reviewing Petition According to David Adams, JD, FDA deputy commissioner for policy, Rock- ville, Md, the agency must respond to the issues raised in the civil petition before it can release its final policy state- ment. The petition is being reviewed, he says, and until the review is completed, the agency cannot comment on the pe- titioner's objections ar.d requests. By law, the FDA must d.::auu lb0 days of receiving the petition; however, it may respond more quickly than that, Adams says. Considering the extreme views ex- pressed in the petition, it is not likely that the FDA will be willing or able to satisfy the foundation's demands. In the event of a lawsuit. the foundation's ex- treme position is not likely to prevail, says at least one authority on the U S Food, Drug, and Cosmetic Act, the fed- eral law that requires the FDA to regu- late drug labeling. Commercial Speech Not So Free The foundation a.dmi+,s t,har the T-iS Supreme Court has differentiated be- tween commercial and noncommercial speech and has allowed the government to regulate commercial speech under cer- tain circumstances. However, its peti- tion claims that "much of the speech that the FDA is attempting to regulate is noncommercial speech because it is not uttered for the purpose of 'propos- ing a commercial transaction.' While manufacturers may have an economic motivation in disseminating scientific in- formation regarding the usefulness of • their products....[T]he absence of anN explicit or implicit proposition of a com- mercial transaction takes speech out of JAMA February 2 1994-Vol 2?' No = the realm of commercial speech and thus out of the realm of virtuall;: all FDA regulation." To regulate truthful commercial speech, the government must be able to show that (1) it seeks to achieve a sub- stantial interest; (2) the regulation di- rectly advances this interest; and (3) the regulation is no more intrusive than nec- essary to serve that interest. The peti- tion argues that the FDA's conduct fails this test. However, the petition appears to have omitted an essential word in describing the Food, Drug, and Cosmetic Act. Ac- cording to Peter Barton Hutt, an attor- ney in private practice in Washington, DC, who is a lecturer at Harvard Law School, Cambridge, Mass, and a former general counsel for the FDA, the act requires the FDA to regulate false or misleading promotional speech. When a company selects and disseminates only scientific information that portrays its drug or medical device as superior, that speech is misleading and the FDA has a federal mandate to regulate that speech, he says. According to Hutt, the Supreme Court has ruled that false or misleading pro- motional speech is not protected by the Constitution. "While the FDA has the authority and the mandate of Congress to prevent drug companies from dissemi- nating misleading or false information, it must do it in the least objectionable, least intrusive manner, not only to pro- tect free speech but to encourage it," he says. "The heart of the matter is finding a way to prevent manufacturers from making false or misleading claims about drugs and medical devices while encour- aging free speech, disseminating impor- tant new medical information, and en- couraging continuing medical education, which are all very important to the prac- tice of good medicine," Hutt says. Comfortable With FDA Guidelines Tha latest delay in issuing the final FDA policy statement on industry-sup- ported scientific and educational activi- ties came as an unwelcome surprise to Martin Shickman, MD, clinical profes- sor of medicine and assistant dean for postgraduate and community education, UCLA School of Medicine, Los Ange- les. Calif. Shickman, a respected leader in the CME community, says, "As far as we're concerned, this was a settled is- sue. The education community is very comfortable with the FDA draft policy guidelines and has been operating un- der them for quite a while. "Although the publication of the final regulations has been delayed several times, the education community has ac- cepted the [FDA's draft guidelines] as the standard for determining how to ac- cept industry money for the production of accredited CME programs. These guidelines have helped the education community to strengthen the credibil- ity and integrity of its accredited CME programs." Indeed, Shickman says, the medical education community and the FDA have moved on to the next step. "We're now trying to develop appropriate guidelines for industry involvement in the prepa- ration and dissemination of "durable" scientific and educational materials, which include textbooks, monographs, and journal supplements as well as non- printed media, such as videos, audio pro- grams, computer programs, compact discs, and other technologies. "The FDA has been very flexible. It was willing to listen to medical educa- tors and to modify its first draft of regu- lations so that we think we now have a very reasonable document. I'm not wor- ried about being able to sit down with the FDA to develop reasonable rules and guidelines on durable industry-sup- ported educational materials." Shickman says he has a problem with the laissez-faire policy advocated by the Washington Legal Foundation. "I think we have to have guidelines," he says. If material is truly educational, then the rules regarding off-label speech should not apply, but if the material is promo- tional, it should stick to the FDA's la- beling requirements. "Very often, the medical community is way ahead of the FDA regarding the use of drugs and devices," he says. "Drugs may be used beyond what's printed on the label and that's basically the substance of CME. If you prevent the discussion of off-label use of medi- cations, there would be little point in holding CME programs. One could just read the package insert and one would know all one needs to know about the drug. "However, there's a difference be- tween commercial speech and educa- tional speech, and this boundary is worth protecting," Shickman says. "The power of advertising to mislead is enormous. I would be very reluctant to allow unre- stricted promotion of off-label uses." The dissemination of information on unapproved uses of pharmaceuticals and medical devices must take place in cred- ible forums-properly peer reviewed by specialty organizations-in centers of learning, or in respected journals, if com- panies are to be prevented from dis- guising advertisements as educational materials, Shickman says. -by Andrew A. Skolnict; Meeicai News & Persoectves 333