- The Washington Times - Thursday, March 2, 2000

Three's a crowd in the doctor-patient relationship, but the U.S. Food and Drug Administration (FDA) apparently doesn't plan on butting out of it anytime soon. The agency has set out to deny physicians access to scholarly research that FDA itself acknowledges could be beneficial, to say nothing of lifesaving, for patients. It has done so, in part, because the agency considers doctors too stupid to use the information safely. Thanks to an ambiguous appeals court decision last month, FDA may continue to blindfold doctors when patients need their oversight most.

The focus of the court case, which began in 1994, has to do with research concerning drugs and medical devices that FDA has not approved for specific treatments. By law, the agency is supposed to test drugs and devices to ensure they are safe and effective for an intended use. Once the products pass, a manufacturer can label and promote them accordingly. Using them for any other purpose is considered an "off-label" use or treatment, and it is illegal for manufacturers to advance them as such. It's all for the consumer's protection, of course.

The trouble is researchers and academics have found lots of interesting off-label ways to help patients. According to a 1996 General Accounting Office report, some 56 percent of cancer patients had received at least one drug off-label, and more than 80 percent of AIDS patients received at least one drug off-label. Further, because there is a natural reluctance to conduct on children the kind of experiments necessary to win FDA approval, off-label use in pediatrics is "extensive," the report said. Said a spokesman for the American Medical Association, "In some cases, if you didn't use the drug in the off-label way, you'd be guilty of malpractice."

Not surprisingly, FDA approves of information on off-label uses from sources such as scholarly journals and medical seminars. But there is one big exception: Manufacturers can't supply or provide them. It seems that rather than embark on years of expensive and possibly fruitless clinical trials to win agency approval for an off-label treatment, some manufacturers simply began mailing physicians copies of research published in peer-reviewed journals on their products. Doctors were free to consider the findings in connection with the best interests of the patient and use or discard them as they would. No harm in keeping doctors up with the latest science, right?

To FDA, however, this gray market in information was nothing less than an evasion of a manufacturer's duty to get agency approval for its drugs. It could hardly keep doctors from reading new research. But it could try to keep drug makers from sending it to them. To that end, FDA sent out letters to drug manufacturers warning them against reproducing or distributing scientific and medical articles discussing treatments that the agency had not approved. It subsequently set up formal "guidance" documents telling them what they could and could not do at the copy machine and at medical education seminars. Congress followed with some of its own in 1997.

With doctors and drug makers chafing under the new rules, the Washington Legal Foundation took the agency to court on grounds that they were a violation of its physician members' right to receive information about off-label uses. In short order, the agency found itself in trouble with U.S. District Court Judge Royce Lamberth. Among other things, it tried arguing that it was regulating conduct, not speech, which Judge Lamberth dismissed as "preposterous." It said published research on off-label uses was "inherently misleading" simply because FDA hadn't approved them. "FDA exaggerates its place in the universe," answered the judge. The agency complained that doctors lacked the experience and education to evaluate unapproved treatments. "To endeavor to support a restriction upon speech by alleging that the recipient needs to be shielded from that speech for his or her own protection, which is the gravamen of FDA's claim here," said Judge Lamberth, "is practically an engraved invitation to have the restriction struck." In 1998, he did.

Faced with this unhappy record at the district court, FDA appealed the decision and, in oral arguments, abruptly announced that neither the 1997 law or its "guidances" gave it the authority to regulate manufacturer speech after all. As a result of the "government's clarification," wrote Judge Laurence Silberman for the U.S. Court of Appeals for the District of Columbia, "the dispute between the parties has disappeared before our eyes." He therefore dismissed the appeal and vacated the lower court ruling. The trade journal FDA Week, however, reports that manufacturers aren't sure if the agency will find some other statutory authority to target them for sending out research articles. No one wants to play regulatory roulette with the agency to find out, either.

What is clear is that physicians don't want agency restrictions whatever the mechanism on the information they receive. In a series of surveys the Competitive Enterprise Institute has taken in recent years, 82 percent of emergency room physicians, 79 percent of neurologists and neurosurgeons, 67 percent of cardiologists and 76 percent of oncologists said FDA should not restrict information about treatment the agency hasn't approved. For the sake of the patient, isn't it time to take off their blindfolds?


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