Aspirin can prevent heart attacks. Adult anti-cancer medications are routinely used to treat childhood cancer. An inexpensive anti-water retention drug has been found effective in fighting congestive heart failure.
The Washington Legal Foundation can say this, but the companies that spend millions studying these drugs cannot communicate the information to your doctor. The federal government forbids such critically important speech, even though Medicare provides reimbursement for many “off-label” treatments, and the Food and Drug Administration recognizes the public health benefits of such uses.
Federal regulators’ byzantine approach to off-label speech provides a troubling view of what patients and doctors can expect from more government intrusion into personal health.
Activists, plaintiff lawyers and some in government have consciously besmirched the concept of off-label uses of drugs and medical devices. But doctors’ use of such products beyond those for which the FDA approved them (i.e., only FDA-approved “indications” go on the product “label”) is a firmly established aspect of modern medical practice.
Doctors routinely discover new dosages, combinations and uses for approved treatments. In fact, nearly 60 percent of cancer treatments are off-label. If doctors had to wait for FDA approval of these and other “unapproved” indications, millions would suffer and die. It’s also a fact that Congress did not empower the FDA to regulate the practice of medicine.
These are rather inconvenient truths for federal regulators, who vainly assert complete supremacy with medical product use. To get around their lack of authority, the FDA targets those who are in the best and most interested position to provide information to doctors about off-label uses: drug and device companies. No federal law grants the FDA the power to do this, but no matter.
Agency bureaucrats concocted and applied a theory through rule-making, guidance documents and enforcement actions, that any information, however truthful, that a company provides to doctors about off-label uses renders drugs or devices “misbranded.” The sale of misbranded products exposes businesses and their employees to steep fines, jail sentences and exclusion from government contracts.
The Washington Legal Foundation recognized the fundamental First Amendment freedoms being violated here, along with the serious risks the FDA’s policies imposed on patients, and sued the agency in the mid-1990s. A trial court initially struck down the FDA’s policies on the sharing of medical journal reprints in an opinion where the judge said, “FDA exaggerates its overall place in the universe.” On appeal, though, the FDA maneuvered the judges to find our suit was moot, an outcome that left the constitutional issue in flux and encouraged more civil and criminal actions.
An environment of fear and a vacuum of information on off-label uses has emerged as the status quo during the past decade. Unwilling to risk the stigma of criminal charges or exclusion from federal contracts, drug and device companies regularly settle, transferring billions from their research budgets to the U.S. treasury.
However, patients and their doctors may see some movement toward reason soon, thanks to a lawsuit that drugmaker Allergan recently filed against FDA. The company’s Botox has emerged as a medically accepted treatment for involuntary limb movements (“spasticity”) by adults, along with for children with cerebral palsy.
Medicare reimburses health care providers for such uses. Allergan’s request to add these uses to the Botox label remains mired in the FDA’s approval bureaucracy. Recently, the FDA ordered all botulinum toxin makers to warn doctors about risks related to the off-label use of this substance. Allergan feels that the FDA’s warning is incomplete and wants to share information with doctors that can further protect patients. But they fear prosecution for such an off-label communication.
The key question for the judge in Allergan’s suit is whether the goals of the government’s off-label policy (encouraging companies to seek on-label approval for new uses) can be met without banning speech.
Why, for instance, can’t the FDA simply require clear disclosures that the information given to a doctor involves uses not approved by the agency? The agency assumes that instead of independently evaluating and confirming company-provided information, doctors will follow the manufacturers’ suggestions like lemmings.
The very same distrust that provokes the FDA and Justice Department policy on off-label information motivates the current drive toward greater government involvement in all aspects of health care.
They don’t trust that patients and their personal physicians can make the best choices. Such a patronizing opinion of Americans undermines the creative and entrepreneurial spirit that has made U.S. medical technology and care the world’s best.
Daniel J. Popeo is chairman and general counsel of the Washington Legal Foundation.