President Barack Obama promised to shake up the Food and Drug Administration, so it's no surprise that his new FDA leadership team has made bold moves. Deputy Commissioner Joshua Sharfstein, who led the agency until Commissioner Margaret Hamburg was approved by the Senate on May 18, announced his presence with authority.
In his first two months, Sharfstein's FDA has threatened to regulate Cheerios as a drug because its label says it can help lower your cholesterol and proposed action against drug companies because Google Internet searches for their products don't show enough safety information.
Sharfstein was chosen to lead the FDA's drug enforcement efforts in part due to his connections as a former staff member for Rep. Henry Waxman (D-Cal.), chairman of the congressional committee that oversees the FDA, and one of the pharmaceutical industry's biggest critics.
Since he's already shown a desire to clamp down on even minor infractions, drug makers and the medical community are holding their breath over what Sharfstein may do next. One likely move is a crack down on so-called "off label" prescribing of drugs, which has been one of Waxman's high priorities for years.
When the FDA approves new drugs or medical devices, they are approved to treat specific conditions in particular populations, which are identified on the products' labels. But once they are on the market, doctors are free to prescribe drugs and devices for any safe and effective use, including ones not indicated on the label.
Getting FDA approval to add another use to a drug's label is time consuming and very expensive, even after rigorous clinical testing shows the new use to be safe and effective. But physicians read medical journals. And if they find, for example, that a certain liver cancer drug is effective in treating kidney cancer, or that an antidepressant approved for adults also works for teenagers, these other uses tend to be adopted.
This practice of off-label prescribing is widespread, and is common in every field of medicine. By some estimates, as many as 60 percent of all prescriptions written are for off-label uses. The American Medical Association has repeatedly studied the practice and concluded that "physicians have the training and experience to determine what is the best or preferred method of treatment for their patients."
Accordingly, the AMA says off-label prescribing should often be considered "reasonable and necessary medical care, irrespective of labeling." Indeed, physicians may even be subject to malpractice liability if they do not use drugs and devices for off-label indications when doing so constitutes the medically recognized standard of care.
Still, certain members of Congress and bureaucrats in the FDA think doctors should prescribe nothing without the express consent of the federal government. The FDA, for example, proposed regulating off-label drug use in 1972, but gave this up after vigorous objection from the medical community. Beginning in the 1990s, however, FDA began restricting the ability of pharmaceutical manufacturers to give physicians peer-reviewed journal articles and other information about off-label uses of their drugs.
FDA treats any drug information distributed by manufacturers, no matter what its form, as part of the product label. So as far as the agency is concerned, mailing out reprints of peer-reviewed journal articles describing an off-label use makes the drug or device "mis-branded."
Physicians try to keep abreast of new research findings, but they can't read every issue of the hundreds of medical journals published in this country. So drug makers have long distributed journal reprints in an effort to promote their products. Regulators regard the practice as grubby commercial marketing, but the distribution of scientific studies allows physicians to be better informed about new developments and enables them to make better treatment recommendations for their patients.
The practice also happens to be protected by the First Amendment. In a series of challenges to FDA's reprint restrictions, federal courts have held that the policies "restricted considerably more speech than necessary" to ensure the information was truthful and not misleading. FDA may monitor the practice to ensure the information is not biased, but forbidding the practice altogether is unconstitutional.
By 2007, recognizing that the FDA could not ban the dissemination of all information about off-label drug uses, the agency published a guidance document in the waning days of the Bush Administration that explained what procedures drug firms had to follow in order to be within the boundaries of the law.
Rep. Waxman, however, chaffed at even this modest step. He claimed the guidance would promote "potentially dangerous uses" of drugs and would "short-circuit the FDA review and approval process."
Not only did Waxman criticize allegedly "abusive marketing practices" by the drug industry, he even attacked the integrity of medical journals themselves and the peer-review process, and he insisted that FDA bureaucrats be placed in the position of judging the quality of the scientific literature.
It's no wonder industry observers and the medical community suspect that Waxman's acolyte Joshua Sharfstein will soon turn his sights toward restricting this important and beneficial mechanism that inexpensively facilitates the dissemination of valuable information to physicians and their patients.
Opponents of off-label prescribing seem unable to balance the regulatory objective of protecting patients from unsafe drugs against the prerogative of physicians to use their best professional judgment to treat individual patients. They downplay the costs of FDA approval, exaggerate the credulity of physicians and their willingness to unquestioningly trust information distributed by drug manufacturers, and ignore the significant benefits off-label prescribing offers for patient care.
Physicians are reluctant to see FDA further restrict information about off-label uses. They know that the practice has large benefits and few costs. Its use should be extended, not curtailed by stricter regulation. Unfortunately, the FDA has a long, troubling history of succumbing to political pressure even when it harms the interests of doctors and their patients.
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