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 doctor/patient relationship.
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 ads.
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 therapies.
"Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert. Every...
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 say.
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 said.
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.