This weekly column offers opinions on the latest pharmaceutical industry news.
Open any magazine or flick on the television, and chances are you’ll see an advertisement for an arthritis treatment, an erectile dysfunction drug, an anticlotting agent, or some other medicine you don’t need.
For years, doctors have complained these kinds of ads targeted directly to consumers can sway patients to ask for unnecessary, and potentially harmful, prescription drugs. The American Medical Association, the nation’s most influential physicians group, was long mum on the subject. But last month, the 168-year-old organization — which represents around 235,000 doctors — finally took a stand, calling for an outright ban on consumer ads for prescription drugs and medical devices.
“Now is the time,” Dr. Patrice Harris, chair-elect of the AMA Board of Trustees and a psychiatrist in Atlanta, told STAT. “We hope to make this a reality.”
Whether this notion is realistic is debatable.
For a ban to go into effect, Congress would have to pass a new law. And given the slim chances for political change, the AMA might be better off reaching a compromise than setting up an antagonistic relationship with drug makers.
The United States is the only country other than New Zealand that permits drug advertising directed at consumers. Last year, the pharmaceutical industry spent $4.8 billion pitching its products and messages to Americans, a 17 percent increase from 2013, according to the market research firm Kantar Media.
That much money buys a lot of airtime — so it’s no wonder that physicians gripe that drug ads can create inappropriate expectations in consumers or make doctors feel pressured to write prescriptions out of concern their patients will go elsewhere.
But the AMA is now seizing on another reason for a ban. The organization argues that the ads largely feature the latest and priciest medicines that few can afford.
“Most of the ads are often for newer drugs that are getting more expensive,” said John Mack, a marketing consultant to drug makers and publisher of Pharma Marketing News. “I think their concerns are valid.”
By pointing to high prices, the AMA is making a smart move. The accelerating cost of medicines has galvanized Americans. About three-quarters of the public believes that prices for brand-name drugs are too high, according to a poll conducted last month by STAT and the Harvard T.H. Chan School of Public Health.
This tactic is more likely to resonate than the most commonly voiced arguments against drug ads — namely, that they misinform patients, overemphasize benefits, and encourage overuse. In another recent public opinion poll from the Kaiser Family Foundation, about half of the respondents said that prescription drug advertising is mostly a good thing and that the ads do a good job of describing potential benefits and side effects.
The fact is that a majority of Americans believe drug ads allow greater patient involvement in health care decisions — and the Pharmaceutical Research and Manufacturers of America agrees. “It’s not a bad thing for patients to bring questions to the doctor’s office,” said Dr. Michael Ybarra, an emergency physician and the trade group’s senior director of alliance development.
But even spinning the issue as one of affordability probably won’t yield congressional action.
Right now, the Food and Drug Administration can review proposed TV ads ahead of broadcast. And the agency can then ask for changes if an ad includes false or misleading information, or if serious risks are not disclosed, according to Georgia State University College of Law professor Patti Zettler, a former FDA associate chief counsel. Yet, the FDA does not have the power to ban advertising outright. Only Congress has that authority.
Lawmakers have pushed bills to ban drug ads before, but a new effort is likely to be extremely contentious because of criticism that any limits on drug advertising would trample on the free speech rights of pharmaceutical companies.
“There could be a very serious challenge,” said Sonja West, an associate professor at the University of Georgia School of Law. Courts have ruled that “truthful information” about medicines has public value, West noted, “so it should not be regulated or banned unless there’s an important government interest.”
One solution would be to temporarily ban consumer advertising for a period after a drug first hits the market. Newly launched medicines often bring unexpected side effects. And according to David Vladek, a professor at Georgetown University Law Center who previously led the Bureau of Consumer Protection at the US Federal Trade Commission, banning ads for a couple of years to see if any serious problems arise could serve the public interest. In this way, a two-year ban, said Vladek, would probably withstand a constitutional challenge.
But there’s another simpler path to reining in drug ads, and it involves a word few are willing to utter in Washington: compromise.
Some drug companies have started to voluntarily limit their advertising. In August, for example, after the female libido treatment Addyi gained approval, the drug’s sponsor, Sprout Pharmaceuticals, said it would not promote the pill on TV or radio for up to 18 months to help ensure the drug isn’t overused before any and all the side effects are known.
Clearly, drug makers have free speech rights. But there is an equally compelling case to be made that consumers should receive unbiased information that does not unnecessarily jeopardize their health or increase costs.
The AMA’s Harris said the organization is open to cooperation. The pharmaceutical industry should be willing to do the same. Promoting medicines is not always the same thing as promoting public health.
Correction: An earlier version of this article mischaracterized how the FDA reviews proposed drug ads. The story was updated on Dec. 8.