Newly Granted Free Speech Could Save Lives

by Sean Tuffnell

Pop quiz. When did freedom of speech finally become a protected right for all Americans?" Answer: July 28, 1999.

Surprised? That's when Federal Judge Royce Lambert made the historic ruling granting unfettered freedom of speech protection for pharmaceutical companies. Before then drug companies' speech was regulated by the Food and Drug Administration (FDA). Not only were drug companies prohibited from telling the general public about beneficial properties of the drugs they made, they couldn't even tell doctors!

Here's the source of the problem. No new prescription drug can be sold without FDA approval. But once a drug is approved to treat one type of illness, doctors often discover it can be used to treat other health problems. This practice is called "off-label" usage. How often does off-label usage actually happen? More than you might think. Roughly half of all drugs are prescribed for off-label purposes.

The General Accounting Office reports 25% of cancer drugs are prescribed for off-label uses and 56% of cancer patients have received at least one off-label medication. For example, the drug Taxol has been approved for treating ovarian cancer for many years. But oncologists discovered that Taxol is also effective for treating certain breast cancers. Under FDA rules, the manufacturer of Taxol could tell physicians about their product's potency in treating ovarian cancer, but not breast cancer. In fact, the manufacturer was even prohibited from sending articles from peer-reviewed medical journals describing Taxol's off-label uses. If they did, pharmaceutical representatives were subject to steep fines from the FDA. This all changed when Lambert decided that free speech [to say nothing of patients' health] was more important than bureaucratic prerogatives.

Lambert's ruling this year was the culmination of a lengthy legal battle over the FDA's regulations. For many years the FDA prevented any communication about off-label usage initiated by manufacturers. Then the Washington Legal Foundation stepped in and filed suit against the FDA for infringing on manufacturers' First Amendment rights. In July of '98, after months of arguments, Lambert ruled in favor of the plaintiffs. The injunction held that then-existing FDA speech restrictions were unconstitutional.

Then in November 1998, the FDA adopted regulations re-imposing the restrictions, arguing that the new regulations should be excluded from Lambert's ruling because they were adopted pursuant to a new law adopted by Congress, the Food and Drug Administration Modernization Act (FDAMA).

Passed in 1997 while the original case was being adjudicated, the FDAMA loosened the FDA's grip a little, but kept the big brother mentality. The act would allow drug companies to educate the public about off-label uses, but they had to submit the information to the FDA first for their approval.

Under this new roadblock, if the FDA thought the information was not balanced, it could require the manufacturer to include additional objective information, or a statement prepared by the FDA about the safety or effectiveness of the new use.

However the question necessarily arose; who'll judge whether an article is balanced or not? According to FDA policy advisor Ilisa Bernstein, the government would "rely on the editorial process."

These new restrictions angered a lot of people, including Judge Lambert. In his final ruling this year Lambert said: "Defendants make the argument that the Court should not apply First Amendment commercial speech scrutiny to the FDAMA because, in the defendant's words, the act 'affirmatively permits' speech so long as it complies with the requirements of the statute. This is, of course, preposterous. The First Amendment is premised upon the idea that people do not need the government's permission to engage in truthful, nonmisleading speech about lawful activity. To give an extreme and obvious example, the government could not justify a law criminalizing criticism of the government on the theory that such a law would 'affirmatively permit' pro-government speech."

While this is a triumph for drug manufacturers and the First Amendment, this is also a victory for us all. Manufacturers are quite often the first to know when research shows their products can be used to treat other problems. This just makes sense, because they have a natural self-interest in the products potential increased use. Yet this inherent self-interest shouldn't be a disqualifier for their ability to exercise their constitutional right to tell those who have the power to use that information for good. One can only guess at how many lives might be saved or helped by one doctor learning of a potential cure from a self-interested company. Thanks, Judge!