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Table of Contents
Table Of Contents
AJLM - [PDF] (Free Download)
American Journal of Law & Medicine Volume 37, Numbers 2 & 3 * 2011. Symposium: Marketing Health: The Growing Role of Commercial Speech Doctrine in FDA Regulation Symposium Authors: Nathan Cortez Margaret Gilhooley Kate Greenwood Aaron S. Kesselheim Coleen Klasmeier David Orentlicher Martin H. Redish Christopher T. Robertson Joanna K. Sax Student Note Authors: Lia Mulligan Amy E. Todd
Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications
Joanna K. Sax, J.D., Ph.D. - [PDF]

The pharmaceutical industry is a competitive business. Companies spend billions of dollars researching and developing new drugs. Many drugs never make it to market. For the limited drugs that make it through the experimental, regulatory, and clinical rigors of drug development, companies recoup their lost expenditures for the drugs that previously failed. Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company's decision-making process regarding full disclosure on a particular new drug. An example of this type of conflict was seen in the silicone breast implant fiasco in the 1970s, 1980s, and 1990s. Dow Corning, the manufacturer of the implants, withheld important data from long-term animal models that demonstrated adverse effects from the breast implants. Further, Dow failed to conduct long-term studies on breast implants, even when armed with data indicating that such studies were necessary to ensure the continued health of the patients. Presumably, Dow stood to lose large sums of money if it conducted the long-term studies because it might establish the implants were harmful. It took litigation to expose Dow's failure to conduct the proper studies of the long-term effects of its implants.
Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech
Aaron S. Kesselheim, M.D., J.D., M.P.H. - [PDF]

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use. Once a drug is approved, however, the FDA cannot control how physicians actually prescribe it. Physicians can prescribe any drug for any medical condition, even outside of the parameters of the label, for a so-called "off-label" use. Therefore, off-label use is the prescription of a pharmaceutical product at a dose and/or for a condition that the FDA has either not reviewed or not approved. Off-label uses of drugs are commonplace. For example, most drugs historically were tested and approved for use in adults; therefore, physicians who wanted to treat similar indications in pediatric patients by definition had to use the drugs off-label.
Commercial Speech and Off-Label Drug Uses: What Role for Wide Acceptance, General Recognition and Research Incentives?
Margaret Gilhooley - [PDF]

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures. Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide "truthful information" to doctors about "widely accepted" off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to "widely accepted" uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks.
The Ban on "Off-Label" Pharmaceutical Promotion: Constitutionally Permissible Prophylaxis Against False or Misleading Commercial Speech?
Kate Greenwood - [PDF]

Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal-and beneficial-products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.
The Commercial Speech Doctrine in Health Regulation: The Clash Between the Public Interest in a Robust First Amendment and the Public Interest in Effective Protection from Harm
David Orentlicher, M.D., J.D. - [PDF]

Historically, government has been given more leeway when invoking its interests in safeguarding the public health than when asserting other state interests. Thus, for example, when considering a constitutional challenge to mandatory smallpox immunization in Jacobson v. Massachusetts, the Supreme Court employed its highly deferential, rational basis review rather than the stricter level of scrutiny that it normally employs when individuals assert interests in bodily integrity. Similarly, Congress and the Food and Drug Administration (FDA) have imposed greater restrictions on the speech of pharmaceutical companies than have been considered acceptable for speech in other commercial settings. In recent years, however, it appears that a trend is developing toward applying the same level of constitutional scrutiny to health regulation. In Abigail Alliance, a three-judge panel in the U.S. Court of Appeals for the D.C. Circuit overrode FDA regulations to recognize a constitutional right of access for patients to experimental chemotherapy. In Western States, the U.S. Supreme Court struck down advertising restrictions imposed on pharmacies by Congress.
Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection
Coleen Klasmeier, Martin H. Redish - [PDF]

In order to protect the nation from harmful or worthless drugs and devices, the Food and Drug Administration (FDA or the Agency) is legislatively authorized to restrict the sale of prescription drugs or medical devices to those whose efficacy and safety have been reviewed and approved by the Agency. Drugs and devices are approved for a specific medical purpose. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such "off-label" treatments have proven to be essential to the successful treatment of some very serious illnesses.
The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment
Christopher T. Robertson - [PDF]

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions--the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals fail to mandate that industry funders utilize such a solution, the federal government has several regulatory levers available, including conditioning federal funding and direct regulation, both of which could be done without violating the First Amendment.
Can Speech by FDA-Regulated Firms Ever be Noncommercial?
Nathan Cortez - [PDF]

For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and Cosmetic Act "depends on the use of words" and that its requirements can "explicitly limit speech." For seventy years, the FDA had little reason to worry about First Amendment constraints. But since 1976, when the Supreme Court reversed its longstanding position that the First Amendment does not protect commercial speech, the Agency has had to confront--perhaps more than any other federal agency--the free speech rights of regulated firms. But how far do those rights extend, and what room do they leave for regulators like the FDA? The answer largely depends on another question: Is the speech commercial or noncommercial? The distinction is paramount. If speech by a regulated firm is commercial, then the FDA can ensure that it is not false or misleading; the Agency can require or compel certain speech; it can impose prior restraints; and it can even limit truthful speech, all within certain parameters. But if the speech is noncommercial, the FDA may not do many--if any--of these things. The distinction thus determines the extent to which the government can regulate, if at all.
Notes and Comments
No Need for More Regulation: Payors and Their Role in Balancing the Cost and Safety Considerations of Off-Label Prescriptions
Amy E. Todd - [PDF]

In 2009, health care expenditures in the United States totaled $2.5 trillion and accounted for almost eighteen percent of the national Gross Domestic Product (GDP). Rising health care costs are an increasing concern in the national health care industry and in government policy reform. When estimates show that thirty percent of health care is unnecessary, improving quality and efficiency of health care could eliminate a significant amount of excessive spending. Prescription drugs contributed to ten percent of national health expenditures in 2009, comprising about $250 billion. And while the rate of growth for overall health care spending declined as a result of the recent recession, "the number of prescription drugs dispensed rebounded to prerecession rate of growth." Estimates show that off-label drug use comprises between twenty and sixty percent of U.S. prescriptions. This could be a troubling percentage considering that off-label use carries an increased risk of harm or ineffectiveness.
You Can't Say That on Television: Constitutional Analysis of a Direct-to-Consumer Pharmaceutical Advertising Ban
Lia Mulligan - [PDF]

In one year, you will watch roughly sixteen hours of pharmaceutical advertisements. Sometime during those sixteen hours, you may recognize in yourself the symptoms portrayed in the advertisements. You may even wonder whether you would benefit from a particular drug. But will you visit your doctor with the fear that you may be suffering from a previously undiagnosed disease? Will you encourage your doctor to prescribe the medication you saw in the advertisements? Will your insurance cover the costs of your medication? More importantly, will you even need the medication at all? The trend in the pharmaceutical industry to increase yearly spending on direct-to-consumer pharmaceutical advertising (DTCA) seems almost disrespectful considering the magnitude of the healthcare crisis in which the United States is currently embroiled. This notion is inflamed when accounting for the fact that (arguably) one of the biggest problems in our healthcare system is the amount of money spent on healthcare each year. DTCA has been a catalyst for controversy ever since it became a viable marketing tool in the 1970s. In light of recent economic developments, the focus of the debate has shifted to the ultimate all-or-nothing question: is it finally time to ban DTCA for good?