With the announcement of a crackdown on deceptive advertising by pharmaceutical companies, RFK Jr. is once again showing that he may not be a complete crackpot. At his apparent direction, the Food and Drug Administration said it is sending about 100 cease-and-desist letters to drugmakers found to be making use of broadcast and digital ads that downplay the safety risks of their products.
The FDA’s move was reinforced by a presidential memorandum suggesting that the administration will move to change federal drug advertising policy, which since 1997 has allowed companies to limit the amount of information they have to include on harmful side effects. Today, the pharmaceutical industry spends billions of dollars a year on consumer advertising, a cost that helps drive up drug prices.
Marketing drugs to consumers has a long and contested history. It was the business model of the 19th century patent medicine purveyors, who promoted their dubious products directly to users. To counteract the hucksters, entrepreneurs such as Eli Lilly began to create what became known as ethical drug operations to make safer remedies available to medical professionals. At the same time, there was a move by reformers such as Dr. Harvey Wiley to get the federal government to regulate the industry. The result was the 1906 Pure Food and Drugs Act, which among other things banned false and misleading claims. The 1938 Food, Drug and Cosmetic Act imposed further restrictions.
As a result, for decades, drugmakers focused on marketing to doctors through ads in medical journals and visits from sales representatives known as detail men. It turned out, however, that the ethical drugmakers could be as dishonest as the patent medicine purveyors. In the late 1950s Pfizer was embroiled in a controversy over deceptive ads in the journals.
It was not until the 1990s that the pharmaceutical industry began pushing for greater freedom to communicate directly with consumers. It succeeded in getting the FDA to issue new rules allowing broadcast ads that included only limited safety warnings.
Along with a flood of advertisements came a wave of scandals. In 2000, for example, the FDA warned Pfizer and Pharmacia, co-marketers of the arthritis drug Celebrex, that the consumer ads they were running for the medication were false and misleading. In 2003 Pfizer paid $6 million to settle with 19 states that had accused the company of using misleading ads to promote its Zithromax medication for children’s ear infections.
In 1999 a federal judge ordered Eli Lilly to stop promoting its osteoporosis drug Evista with what were said to be false claims that the medication reduced the risk of breast cancer. Lilly later pled guilty and paid $36 million in connection with the illegal promotion of Evista. In 2005 the FDA warned Lilly that its television advertisement for Strattera, a drug for attention deficit hyperactivity disorder, understated the risks associated with the medication.
In 2004 the FDA sent a warning letter to GlaxoSmithKline charging that a TV advertisement for the antidepressant Paxil was false and misleading.
In 2008 Merck agreed to pay $58 million to settle charges brought by more than two dozen states that the company’s advertisements for the arthritis medication Vioxx deceptively downplayed the health risks of the drug.
The list could go on. The upshot is that drugmakers frequently abused their new marketing freedom. The FDA and other regulators took some actions against the companies, but there is no evidence that their enforcement actions had much of a deterrent effect.
This brings us back to the present. It is good that the Trump and RFK Jr. are voicing concern about deceptive marketing, but they are not proposing any specific new initiatives. It is also unclear that they are serious about enforcing existing rules more vigorously. After all, this is an administration that has generally demonized regulation and has retreated from strong action against corporate miscreants.
Time will tell whether what they are doing amounts to anything substantial or is just another empty political gesture.