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.
topics:
Prescription Drugs, Regulation
