Senate takes up debate on explosion of direct-to-consumer drug ads
July 24, 2001 (Washington) -- Two senators and several consumer
groups raised concerns at a Senate hearing Tuesday that direct-to-consumer, or
DTC, advertisements for prescription drugs may negatively impact the
But the FDA said such ads may have the opposite effect,
actually encouraging consumers to seek treatment and discuss health conditions
with their doctors. The agency appears unlikely to change how it regulates the
The next time your doctor writes you a prescription, consider this: The
medication may not be approved for your specific condition or age group.
But you probably shouldn't call the medical board. The practice, called
"off-label" prescribing, is entirely legal and very common. More than one
in five outpatient prescriptions written in the U.S. are for off-label
"Off-label" means the medication is being used in a manner not specified in
the FDA's approved packaging label, or insert...
Since 1997, when the FDA loosened its restrictions on DTC ads,
drug companies began heavily advertising prescription drugs to the general
public. Consequently, the $791 million the drug industry spent on DTC ads in
1996 jumped to $2.5 billion in 2000.
Consumer and doctor groups argue that these ads spur people to
run to their doctor demanding inappropriate drugs -- sometimes receiving them.
This inflated demand also plays a role in higher overall drug costs, the groups
But the FDA says no studies have been done to prove this, and
until that changes it is difficult to make the case whether the influence is
negative or positive.
"The FDA is not aware of any evidence that DTC promotions
are increasing inappropriate prescribing [of drugs]," the agency's Nancy
Ostrove, PhD, said before the subcommittee on consumer affairs, foreign
commerce, and tourism. However, surveys, including one done by the FDA, suggest
the ads do influence patients to go their doctors and discuss their
particular condition, which could be an important public health service, she
Nancy Chockley, president of the nonprofit National Institute
for Health Care Management, testified that the top 50 drugs most heavily
advertised to consumers increased in sales by 32% last year. Sales of drugs not
on that list increased by only 14% during the same period.
Senator Ron Wyden (D-Ore.) pointed out that in the FDA survey,
81% of patients said their doctor welcomed their questions about a prescription
drug they had seen in an ad. And despite reports of doctors being pestered to
dispense inappropriate medications, only 50% of those in the survey said their
doctor gave them the medication they requested.
Later, Wyden questioned whether ads that offer coupons for free
supplies of a drug are hooking seniors on medication they can't afford.
"I'm troubled by giving seniors discounts ... and getting them bonded to a
very expensive product," he said.
Another issue he brought up was the idea that DTC ads might
sway consumers to opt for more expensive brand-name drugs rather than
Gregory Glover, MD, JD, testified on behalf of the
Pharmaceutical Research and Manufacturers of America, or PhRMA, the group that
represents the pharmaceutical industry. He noted that in many cases the DTC ads
are for newly introduced drugs for which there is no generic alternative.
Glover defended the ads by saying they have a spillover effect of raising
public awareness about treatments.
Sidney Wolfe, MD, director of the consumer advocacy
organization Public Citizen's Health Research Group, charged the FDA with not
adequately policing these ads, and with not increasing its staff to deal with
the boom in the number of ads out there.
In fact, he said, the number of times the FDA has cited
companies for illegal ads has actually dropped sharply over the past three
years. Until the agency begins to increase enforcement, "Americans -- both
physicians and patients -- will be harmed by prescribing decisions ... based on
all-too-frequently false and misleading information from advertisements,"