By Daniel E. Troy *
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 materialstextbooks and
journal reprintsunder 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
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 usesbut only if they have begun the cumbersome
and expensive process of getting supplemental FDA approval for the
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
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 spironolactoneand
because the publicity surrounding this discovery has been so widespreadit
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
* 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