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In March psychiatrist Peter Gleason prepared to board a train to Maryland after giving a speech to physicians at a luncheon meeting on Long Island, N.Y. According to a report by Alex Berenson in The New York Times on July 22, Gleason was surrounded by a half-dozen federal agents, handcuffed, and driven to a nearby police station. At first, Gleason assumed this was part of an elaborate joke, but he soon discovered that the agents were real and his legal troubles were just beginning. To Gleason’s surprise, he was charged with promoting a drug for purposes not approved by the Food and Drug Administration, so-called off-label promotion�a practice repeated many times in countless physicians’ offices every day. Specifically, the indictment against Gleason included counts of conspiracy to commit health care fraud and introduction of a misbranded drug into interstate commerce, among others. Essentially, the indictment charged that Gleason not only promoted the off-label use of the drug, but that he did so in exchange for hefty fees. Even more damning, according to prosecutors, is that the main off-label uses regularly touted by Gleason were potentially harmful. The case has touched off new debate about off-label promotion and whether prohibiting manufacturers from promoting off-label uses is beneficial. The conventional wisdom is that the government’s current policy protects the public by ensuring that manufacturers do not promote uses not approved by the FDA. Such a view, however, is shortsighted, and a fear of learning about off-label uses may prevent physicians from making well-informed clinical decisions. The truth is that off-label promotion with appropriate safeguards is in the public’s best interest. APPROVED INFORMATION Under the Food, Drug and Cosmetic Act, the FDA has the broad authority to regulate the development, testing, and distribution of drugs and medical devices in the United States. To distribute prescription drugs or medical devices, a manufacturer is first required to demonstrate, through extensive testing, that the product is safe and effective for its intended uses. The FDA’s authority extends to the labeling of drug products and medical devices. Labeling includes all claims and information about the drug or device’s risks and benefits, directions for use, warnings, contraindications, and associated adverse reactions, if any, and other written materials regarding the drug or device (whether or not the information physically accompanies the product). The term includes almost all promotional activity, including booklets, pamphlets, and all literature that explains or is otherwise textually related to the product. A drug manufacturer is prohibited under most circumstances from disseminating or distributing any promotional or informational materials discussing any uses of the drug that have not been approved by the FDA and included in the package insert. Generally, off-label use of a product refers to the drug being used in a manner not described in the FDA-approved labeling. Examples of such off-label uses include administration of a product for a different disease or use of a drug at a new dosage. If a manufacturer intends to market a product for such a use, it must first submit a supplemental application demonstrating the safety and effectiveness of the drug when so used. Otherwise, promotion or marketing of an unapproved use (barring certain exceptions) before the new approval would be considered misbranding. Notwithstanding the general prohibition against off-label promotion, manufacturers sometimes can disseminate information to health care providers regarding off-label uses. Companies may also sponsor continuing medical education, such as luncheons and seminars, in which physicians discuss clinical developments, including off-label uses for already-approved products, but there are constraints on such events. For example, several government agencies and industry groups have issued guidance requiring that education programs sponsored by manufacturers be free of the manufacturer’s substantive influence, but the Accreditation Council for Continuing Medical Education, which oversees medical education, currently does not require speakers to disclose whether a discussed use is on-label or off-label.Although companies usually may not promote off-label uses, the FDA lacks the express statutory authority to regulate the conduct of health care practitioners. Thus, in most cases, a doctor may prescribe a drug for off-label uses or discuss off-label uses with other physicians. The FDA’s restriction on off-label promotions should be considerably liberalized. Although some strong arguments exist for keeping the FDA’s current posture, far more compelling reasons support liberalizing the prohibition. And this is true on policy grounds alone, even without reaching the First Amendment issues resulting from government restrictions on scientific speech. Prescribing for off-label uses is a common and critical component of medicine. It has become the standard of practice in many communities. Indeed, off-label indications are the primary (or in some cases the only) effective means to combat a number of diseases and conditions. Although the percentage is difficult to pinpoint, some observers (such as Michael Krauss of George Mason University) estimate that up to 60 percent of all prescriptions are for off-label uses. Off-label use of drugs for treating cancer, AIDS, serious wounds, and a variety of pediatric conditions is even more common and has proved highly effective. Estimates indicate that 50 percent of cancer drugs and 80 percent of drugs used in pediatrics and to treat rare diseases are prescribed off-label. Indeed, the FDA itself has conceded that unapproved uses may be appropriate in certain circumstances and may reflect approaches reported in medical literature. The prevalence and acceptance of off-label uses can be seen particularly in the reimbursement policies of both government health care programs and private insurance providers. Medicare and Medicaid will reimburse for off-label use if the therapy is recognized as safe and effective and is supported by one or more of the commonly referenced compendia (that is, the reference guides about prescription drugs used by health care professionals). Medicare permits payment for off-label uses of a new drug or device if patients participate in studies to collect additional data. With private insurance, many states have legislation prohibiting insurance companies from excluding coverage for off-label use of a drug in the treatment of certain ailments. States vary on the limitations on coverage of off-label uses of medical devices, but most strongly discourage insurers from refusing to reimburse such uses. Some states require the reimbursement of off-label treatments of only certain diseases, such as cancer and HIV, while others require coverage of the drug in the treatment of all serious conditions. In sum, it is well established that off-label use is common, and the clear weight of the evidence is that it promotes public health by making certain unapproved therapies available to patients when an FDA review of an otherwise approved drug is not readily available. Because off-label use of drugs and devices is an increasingly effective and preferred method of treating a myriad of diseases and conditions, manufacturers and others must be allowed to disseminate to physicians sound clinical information about off-label uses. This will ensure that physicians make the best-informed clinical decisions. Conversely, restricting the ability of manufacturers to disseminate such information deprives physicians of potentially critical information and ultimately compromises public health. Reducing Costs Permitting manufacturers to disseminate information about off-label indications will also reduce research and development costs. The statistics are daunting: The average cost to bring a new drug to market is fast approaching $1 billion and can take up to 15 years. The relatively new accelerated approval process still involves lengthy approval times and high costs. By allowing promotion of off-label uses of already-approved drugs, manufacturers would not have to go through the lengthy and costly FDA approval process. This would reduce research and development costs�savings that would eventually reach consumers. Removing restrictions on off-label promotion would also help those afflicted with orphan diseases (that is, those diseases that affect fewer than 200,000 people). Because of the small number affected, manufacturers do not find it financially feasible to conduct clinical studies regarding new uses of drugs to treat these diseases. As a result, many orphan diseases are treated through the off-label use of drugs. Allowing manufacturers to disseminate information to physicians about off-label uses to treat orphan diseases would increase the available therapy options. Although some critics argue that not requiring manufacturers to undergo a formal approval process is contrary to protecting public health, these arguments are based on faulty assumptions about how physicians decide what to prescribe. Generally, physicians decide about off-label prescriptions based on published studies, information in professional publications, discussions with other health care professionals, and years of clinical experience. The notion that a physician will prescribe off-label based solely on information from a manufacturer misunderstands how physicians work. Wariness about tort liability keeps most physicians from making rash and clinically unsupported recommendations to patients. Similarly, fear of tort liability would keep most companies from distributing information about off-label uses that are false, misleading, or clearly unsupported by the clinical evidence. Nevertheless, additional safeguards can further assuage concerns. To mitigate potential abuse, the following general requirements should be put in place: (1) Dissemination of information by manufacturers should be to physicians only, (2) any information disseminated by a company must include notification that the uses discussed are off-label, and (3) physicians must expressly notify their patients that a therapy being prescribed is off-label. Manufacturers should be permitted to promote off-label uses to physicians only. Physicians are highly trained clinicians with the professional judgment to determine whether a particular drug is warranted for a particular patient. Given the prevalence of off-label prescribing, it simply makes sense for physicians to have available all the information about the uses of a particular drug. As a corollary, physicians should disclose any financial ties to manufacturers when they discuss products by those companies with other physicians. Direct-to-consumer promotion of off-label uses should remain prohibited. Manufacturers should also be required to expressly indicate that any use discussed in disseminated information is off-label.Finally, to protect consumers, physicians should be required to inform patients when medications are prescribed for off-label uses. Overall, benefits of sharing off-label information far outweigh the risks. Doctors should be free to share this scientific information with other doctors�without fear of prison. Rene Quashie is a senior associate in the D.C. office of Fulbright & Jaworski, where he specializes in health care law. He can be contacted at [email protected]

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