congressional lawmaker has introduced a bill calling for a three-year moratorium on advertising newly approved prescription drugs directly to consumers, reasoning that such a freeze would prevent consumers from receiving inaccurate information and also hold down health care costs.
The bill, known as the Responsibility in Drug Advertising Act, would also prohibit ads from running after the three-year moratorium if the Department of Health and Human Services determines the drug generated “significant” side effects based on studies, scientific literature, and other data. It was introduced by Rep. Rosa DeLauro (D-Conn.).
The legislation, which is designed to amend the federal Food, Drug, and Cosmetic Act, is only the latest effort to squelch direct-to-consumer advertising of prescription medicines. Three months ago, the American Medical Association called for an outright ban on this form of promotion.
For years, consumer groups and physicians have argued that, ever since the Food and Drug Administration revised guidelines in 1997 to permit drug makers to use broadcast advertising, some ads too often encourage patients to seek medicines unnecessarily.
In explaining her reason for introducing the bill, DeLauro cited a similar concern and noted that, in 2007, the World Health Organization recommended against DTC ads, due to “a significant risk” of exposing more patients to side effects from new drugs.
Like the AMA, DeLauro also argued that advertising can inflate health care costs if consumers are prompted to seek newer, higher-priced medicines that drug makers may advertise to quickly trigger sales.
Such a tactic is not surprising. The cost of pharmaceuticals is a hot-button issue that has jolted the American public and, consequently, figured into the presidential race. Over the several months, various congressional lawmakers have held hearings on the topic.
This is not the first time a moratorium has been floated, though. The FDA, in fact, suggested such a move in 1983, although withdrew the notion two years later (see page 13). Since then, the pharmaceutical industry adopted a voluntary code on the timing of consumer ads, although not a specific moratorium.
Before running ads, the code says drug makers should consider the “relative importance” of informing patients of the availability of a new medicine, the complexity of the benefits and risks of a new drug, and the extent to which physicians may be knowledgeable of the ailment the drug is supposed to treat.
But in a note sent to us, a spokeswoman for the Pharmaceutical Research and Manufacturers of America, the industry trade group, disputed the “false notion” that DTC advertising “plays a direct role in the cost of new medicines.”
Meanwhile, she noted that a 2012 survey of patients by Prevention magazine that found 71 percent of people agree that DTC ads “allow people to be more involved with their health care” and 75 percent believe that DTC ads are useful because they “tell people about new treatments.”
The spokeswoman also pointed to a statement made in 2004 by the FDA, after the agency conducted several surveys. “By and large, DTC advertising seems to increase awareness of conditions and treatments, motivate questions for the healthcare provider, and help patients ask better questions,” the FDA concluded in its reports (see page 6).
DeLauro does concede DTC ads can be beneficial. Her legislation would allow the Department of Health and Human Services to waive the three-year moratorium if the advertising “would have an affirmative value to public health.”
Despite public outrage over drug prices, it remains unclear whether her legislation will gain any traction. One industry advocate argued the bill may raise concerns about limitations on free speech and that the industry code makes it unnecessary.
“The PhRMA code already recognizes that, while it may be appropriate to delay DTC sometimes, there are other times when DTC is in the public interest,” said John Kamp, who heads the Coalition for Healthcare Communication. He cited drugs for rare diseases for children as an example.
The pharmaceutical industry, meanwhile, can be expected to lobby against the measure. Kamp noted that DeLauro is a high-ranking minority member of the House Appropriations Committee, including the subcommittee with jurisdiction over the FDA.
We should note, by the way, that New Zealand is the only other country that allows DTC ads.