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.

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.

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.

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.