This week brought news that an inexpensive generic drug is remarkably effective in reducing congestive heart failure. This 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% over two years.

Just one problem. The Food and Drug Administration forbids the manufacturers of this wonder drug from informing doctors about this development. They aren't 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% of anticancer drugs were prescribed off-label, and 56% 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 obtained them from any other source. The FDA was not, he declared, a peer-review mechanism for the scientific community, nor is it the sole arbiter of truth.

Since the court's ruling, however, the FDA has 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 a manufacturer 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 rule. 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. Though briefing on that issue is now complete, Judge Lamberth has yet to rule. So the FDA continues to enforce its regulations.

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 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 keeps in place a ban on the dissemination of information by manufacturers about lifesaving off-label uses of drugs such as spironolactone. Once again, it's up to the courts to rein in an overzealous
FDA.

Daniel E. Troy is a Washington lawyer and an associate scholar at the American Enterprise Institute. He and his firm represent the Washington Legal Foundation in its First Amendment challenge to the FDA's off-label restrictions.