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.
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.
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 generics.
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," he said.