October 01, 1999
Last month brought news that an inexpensive generic drug is remarkably effective in reducing congestive heart failure. The finding is expected to save tens of thousands of lives and reduce hospital expenditures by billions of dollars every year. So dramatic are the results that the New England Journal of Medicine rushed into print a study reporting reduced death rates of 30 percent over two years.
There's just one problem. The Food and Drug Administration has for years forbidden the manufacturers of wonder drugs such as this one from informing doctors about developments like this. Under this policy, manufacturers are not even allowed to send physicians reprints of the New England Journal article.
Why? Because spironolactone, a drug approved decades ago to treat water retention, has not been specifically approved to treat heart failure. That makes the new use "off label," and the FDA considers any manufacturer promotion of off-label uses to be "misbranding," a criminal offense. The FDA has extended this ban to manufacturer dissemination of independently generated, peer-reviewed research reports that discuss off-label uses, such as chapters from medical textbooks and reprints of journal articles.
Off-label use is ubiquitous. Indeed, it often represents the standard of care, so that in many cases a doctor would be committing malpractice if he failed to prescribe an off-label use. According to the General Accounting Office, 25 percent of anticancer drugs were prescribed off-label, and 56 percent of cancer patients have been given at least one drug off-label.
Even an FDA official, in a deposition, said the agency "certainly believe[s] it's very appropriate for physicians to get information about off-label uses from the many sources that they get them." In other words, the FDA approves of doctors learning about off-label uses from seminars, textbooks, the Internet, or colleagues. But it does not permit doctors to receive reprints of medical journal articles from pharmaceutical manufacturers, even if the reprint discloses that the use discussed has not been approved by the FDA.
A year ago, federal judge Royce Lamberth struck down these FDA restrictions. In Washington Legal Foundation v. Friedman, Judge Lamberth rejected the FDA's argument that the promotional speech of drug manufacturers lies entirely outside the scope of the First Amendment. Instead, he analyzed the FDA's restrictions on manufacturer dissemination of so-called enduring materials—textbooks and journal reprints—under the more lenient standard for government restrictions on advertising.
Using that standard, Judge Lamberth found that the FDA's limits were unconstitutional. He forcefully rejected the agency's contention that reprints are inherently misleading when physicians receive them from drug manufacturers but unobjectionable when doctors obtain them from any other source. The FDA is not, he declared, a peer-review mechanism for the scientific community, nor is it the sole arbiter of truth.
The FDA moved to block the decision, arguing that the court had addressed a policy superseded by the 1997 Food and Drug Administration Modernization Act. Based on this law, the FDA asked the court to declare that it need not adhere to the constitutional principles announced in the court's opinion. The reason given was that the new law did indeed permit manufacturers to distribute materials about off-label uses—but only if they have begun the cumbersome and expensive process of getting supplemental FDA approval for the new use.
In answer to these claims, Judge Lamberth in February noted that his decision about the manufacturers' free-speech rights was intended to apply to the principles underlying the FDA's old rules, and not just a particular iteration of the rules. He did, however, ask the parties to address what the scope of his order should be, in light of the 1997 law and the FDA's implementing regulations. On July, 28, 1999, the judge not only reaffirmed his earlier ruling, he also held unconstitutional the provisions of FDAMA which restrict the dissemination by manufacturers of independently generated, peer-reviewed reprints.
Specifically, Lamberth held that the changes in FDA policy effected by the FDAMA had not "brought the FDA into compliance with the First Amendment." He also rejected as "preposterous" the FDA's argument that "the Court should not apply First Amendment commercial speech scrutiny to the FDAMA because, in [FDA's ] words, the act `affirmatively permits' speech so long as it complies with the statute's requirements." Rather, said Lamberth, the First Amendment is based on the idea that people don't need to ask the government before they engage in truthful, nonmisleading speech about lawful activities.
The force of this decision is not likely to deter FDA, which is widely believed to be virtually certain to appeal. FDA might even seek to stay the effect of this decision, which could leave the current restrictions in place. Either way, FDA is expected to continue to defend the restrictions.
Since so many people are affected by the new use of spironolactone—and because the publicity surrounding this discovery has been so widespread—it is unlikely that many cardiologists will fail to learn about its potential, even without the assistance of manufacturers.
But new life-saving off-label uses are discovered all the time. Pharmaceutical manufacturers have the greatest incentive to educate doctors about such uses. As long as they are only reprinting independently generated, peer-reviewed scientific information clearly indicating that the FDA has not approved of the use discussed in the article or book, there is no reasonable basis for any objection.
Despite a ruling saying that its actions violate the First Amendment, the FDA continues to defend a ban on the dissemination of information by manufacturers about lifesaving off-label uses of drugs such as spironolactone. Once again, it's left to the courts to rein in an overzealous FDA.
* Mr. Troy is an associate scholar at AEI and an attorney. He and his firm represent the Washington Legal Foundation in its First Amendment challenge to the FDA's off-label restrictions. An earlier version of this article appeared in the Wall Street Journal on July 23, 1999.