FDA’s Position on Off-Label Use and Promotion of Drugs and Devices and Recent Enforcement Efforts by the Department of Justice

Off-label drug or medical device “use” is the practice of prescribing drugs or medical devices to patients for a purpose not included on the federally approved label. Off-label “marketing” is the practice of attempting to influence physicians to prescribe drugs or devices for off-label purposes. The Federal Food and Drug Administration (FDA) maintains regulatory authority over the proper labeling of drugs and medical devices. This paper summarizes the FDA’s position on off-label use, promotion, and marketing and provides a summary of recent enforcement actions by the U.S. Department of Justice regarding off-label marketing

The Edna McConnell Clark Foundation's Tropical Disease Research Program: A 25-Year Retrospective Review 1976-1999

Documents and details the foundation's commitment to the program from its inception, and provides an analysis of its successes until the completion of the program in 1999

Enforcing Integrity

Over the past several years, the marketing practices of large pharmaceutical companies have come under intense scrutiny. The government spends years investigating and building cases against pharmaceutical manufacturers that engage in illegal promotional activities to promote their drugs but does not prosecute them. Instead, the government enters into Corporate Integrity Agreements (CIAs) with the pharmaceutical giants. As a result, the pharmaceutical manufacturers are able to avoid the collateral consequences of conviction, such as exclusion from Medicare and Medicaid. Participation in Medicare and Medicaid is crucial for a pharmaceutical manufacturer because the government spends over $60 Billion per year through those programs on reimbursements for prescription drugs. In return for remaining eligible for Medicare and Medicaid reimbursements for their drugs, the manufacturer pays the government a huge fine and agrees to structural changes to the company designed to prevent future marketing violations. The CIA seems like a reasonable response to the marketing violations until the pharmaceutical company engages in illegal marketing practices while still under the CIA for the previous marketing violation. In those situations, the government remains unwilling to pursue the pharmaceutical manufacturers in court and seek exclusion from Medicare and Medicaid. Rather than pursue exclusion, the government has entered into successive CIAs with pharmaceutical manufacturers and collected additional fines. The government enters into these agreements because exclusion of the manufacturer from participating in Medicare and Medicaid has devastating consequences that spill over to innocent patients, employees, and stockholders. Not only does the impact of the exclusion hit innocent third parties, but its imposition on the manufacturer substantially outweighs the harm the manufacturer inflicts through its improper marketing practices. The penalty for improperly marketing one drug is exclusion of all drugs produced by that manufacturer from Medicare and Medicaid. It is the government’s unwillingness to harm innocent third parties and its reluctance to impose a disproportionate penalty on drug manufacturers that leads them to CIAs. Thus, the problem is not that the government uses CIAs to combat health care fraud; it is that the government lacks penalties of increasing severity to impose when a manufacturer violates an existing CIA. This Article argues that neither the exclusion of manufacturers from Medicare and Medicaid nor the use of Corporate Integrity Agreements coupled with large fines is an effective deterrent for pharmaceutical manufacturers that repeatedly engage in illegal marketing activities to promote their drugs. In particular, it argues that CIAs fail to deter drug manufacturers from engaging in illegal promotional practices because the penalty imposed and the cost of compliance with the CIA are significantly lower than the profits that a pharmaceutical company can obtain by illegally marketing its drugs. Further, the government’s willingness to enter into multiple CIAs with repeat offenders of the marketing rules rather than exclude them from Medicare and Medicaid substantially diminishes the ability of CIAs to deter illegal promotional activities. Finally, this Article argues that there are viable alternatives to be used in place of or in conjunction with CIAs, such as funding clinical trials, compulsory licensing, corporate officer liability, and targeted exclusion, that would be more effective deterrents for repeat offenders. Each of these remedies could be used to increase the severity of punishment when a one-time offender becomes a repeat offender. This Article concludes that these proposed measures would be more successful than CIAs at increasing compliance and enforcing integrity in drug promotion

Marketing health care in South East Asia

The Asia /Pacific basin is currently the centre of business activity. One particular area in this basin which has caught the attention of businessmen is the Asean region especially the countries of Thailand, Singapore and Malaysia. Investment has poured into these nations and there is rapid development. One particular business which has developed very rapidly is the health care segment. The economies of these countries are flourishing and the standard of health care management has improved. This means there is a ready market for heath care. The thesis begins with a brief introduction to the country profiles and then moves to the health care system of the three countries. The pharmaceutical industry of the three nations are highlighted. The manufacturing base is small Malaysia but is extensive in Thailand and Singapore. Singapore's Economic Development Board is luring high technology based Industries and showering them with generous benefits. Multinationals feel that having Singapore as their base they could tap the entire Asia/Pacific region. Patent rights has become a major issue in Thailand and the relaxed rules has encouraged the mushrooming of generics which has threatened the very existence of multinationals. The distribution network of the pharmaceutical industry is mentioned. Special mention is made to the G.P.O in Thailand which acts as a major purchasing, manufacturing and distributing unit. The various drug regulations in the three countries are published, with special mention given to the registration exercise which is being conducted in Malaysia. The advertising code, O.T.C products and self medication has found a place in the thesis. The cross country analysis throws light on the pharmaceutical business in the three nations. The emergence of Japan as a future source for pharmaceutical technology is explained briefly. The conclusion and the mention of Singapore as the venue for the pharmaceutical business takes us through the last pages of the thesis