Search Results

This chapter assesses the potential benefits and harms of actual and possible uses of psychopharmacological agents for prevention, therapy, and enhancement. These include using drugs to prevent or erase memories of fear-arousing events. They also include drugs that could alter the neural circuitry of violent offenders. Placebos as a psychological intervention and their effects on the brain and mind are considered, focusing on whether it can be ethical to give placebos to treat symptoms associated with different medical conditions. Finally, possible off-label uses of drugs for enhancing cognition and mood are discussed.

The FDA prevents prescription drug manufacturers from directly promoting their products for uses that the FDA has not validated (“off-label” uses), but in the recent case of United States v. Caronia, the United States Court of Appeals for the Second Circuit held that the First Amendment supports manufacturers’ freedom to advertise off-label uses. Since unfettered off-label promotion will lead to substantial public health risks, this chapter discusses how the government could make a stronger case that its current regulatory framework for off-label promotion satisfies the criteria of the First Amendment’s protection of commercial speech.

Physicians often prescribe drugs and devices for “off-label” uses not reviewed or approved by the FDA, but the makers of those products are not allowed to promote those uses, as that would evince an intent contrary to their approved labels. This regulatory equilibrium is precarious under an expanding conception of the First Amendment, but such judicial and scholarly analyses turn on unwarranted presumptions about the truth of the manufacturers' promotional claims, a truth that is unknowable until tested by the FDA or courts.

This chapter explains why, given the fact that off-label use of prescription drugs is itself a purely legal activity, the prohibition on off-label promotion contravenes core notions of free expression guaranteed by the First Amendment. It demonstrates that under current standards of commercial speech protection the prohibition clearly fails, absent a finding that the promotion is false or misleading, because it constitutes suppression of truthful expression advocating a lawful activity. Such prohibitions are categorically deemed unconstitutional, because they represent the most invidious form of governmental manipulation of citizen behavior through the selective suppression of speech.

This chapter proposes deploying electronic prescription technology as an interface connecting the FDA with physicians and patient records to enhance its regulation of medical product usage. Such an e-prescription platform would enable the Agency both (1) to directly and immediately provide physicians with salient warnings, advisories, and best-practice protocols at the time they prescribe treatment and (2) to monitor and elicit compliance, product usage (including off-label usage), and treatment-result information that will comprise a comprehensive, systematic, and real-time databank for facilitating more reliable and expeditious oversight and regulation.

The U.S. Food and Drug Administration is statutorily responsible for ensuring that prescription drugs and medical devices meet evidential standards for safety and efficacy before they are approved for marketing. Nevertheless, serious evidential gaps remain for every product at the time of approval, more so for devices than drugs, and post-approval uptake is driven more by market forces than scientific evidence of superiority. Moreover, to obtain approval for marketing, medical product makers not statutorily required to evaluate the comparative effectiveness of their products, and infrequently have a business case to do so. Federally-mandated comparative effectiveness research will complement what is known about the safety and efficacy of approved pharmaceutical products and devices, a prospect that many in the medical products industry find threatening.

The pharmaceutical industry has been heavily criticized for the amount it spends, as well as for the tactics it uses to promote drugs. This chapter begins by providing an overview of pharmaceutical promotion in recent years, and then offers a closer examination of each major promotional channel, including detailing, free samples, journal advertising, sponsorship of medical conferences, direct-to-consumer advertising, and e-promotion. It systematically reviews the contemporary health economics literature on the effect of pharmaceutical promotion on demand, pricing, utilization, and quality of care. The role of the FDA in regulating drug advertising is also examined, including the debate on whether the agency’s responsibility in this area should be expanded or curtailed. The last section of the chapter examines the issues of false or misleading advertising and off-label promotion. The focus in this chapter is on the US drug market.

This chapter explores the paradoxical assertion of freedom of therapeutic choice in the context of reimbursed health care. Cries of “rationing!” and “death panel!” are directed at every suggestion of a limitation on government insurance coverage. This chapter traces the history of the notion of a “right to be reimbursed” for one’s therapeutic choices since the 1930s. It explores the persistent public insistence on “a right to choose one’s doctor” in insurance plans. It describes the history of drug formularies and patients’ resistance to them. The chapter focuses most intensively on the controversy surrounding the FDA’s November 2011 withdrawal of provisional approval of Avastin for the treatment of breast cancer. Conservatives and patient groups used the language of rights to attack this decision even though it did not remove the drug from the market; the protesters’ real fear was that insurance plans would stop reimbursing patients for this use.

Since medical paternalism is wrong in the clinical context, it should be rejected in public policy as well. But even if paternalistic public health policies were permissible, it is not clear that prohibitive pharmaceutical regulations are necessary to promote public health. Prohibitions could undermine health in some cases, for example, if prescription requirements make patients more deferential to physicians and tolerant of medical risks. Premarket testing requirements cause people to suffer and die waiting for new drugs to get approved, and they discourage new drug development. This is not to say that regulation serves no purpose. Pharmaceutical regulators provide a valuable pubic good by overseeing testing for new drugs and by certifying drugs that they deem generally safe and effective. But the benefits of regulation do not require that the regulations be prohibitive, and prohibitive regulations not only violate patients’ rights, they may also cost lives.