Bill to ban DTC adds to industry's woes

Photo credit: King-of-Herrings/Creative Commons

A lawmaker has proposed legislation that would place a three-year hold on nearly all direct-to-consumer advertising. The bill comes at a time when the drug industry’s marketing and pricing practices are being closely scrutinized.

Rep. Rosa DeLauro (D-CT) introduced The Responsibility in Drug Advertising Act earlier this month.

In a release, DeLauro explained the motivation behind it, citing the need to better protect patients. “At the end of the day, we should allow informed medical professionals, not advertising executives to guide our healthcare spending,” she said. “We must protect consumers from taking medications that may be unnecessary.”

Her office did not immediately respond to inquiries for comment.

DeLauro’s proposed bill adds to a growing backlash against the pharma industry over concerns about how companies price their drugs. The week before DeLauro introduced the bill, House lawmakers held a hearing on drug pricing, with some lambasting pharma executives over those rising drug prices. Presidential candidate Hillary Clinton has also targeted prescription drug ads, saying she would demand an end to tax breaks for DTC advertising as well as add a mandatory pre-ad clearance by the FDA, which would be funded by industry.

“It’s pile on pharma time,” said John Kamp, executive director for the Coalition for Healthcare Communication. He suggested that the pharma industry may be an easy target for candidates and lawmakers come election time.

The legislation does not seek to ban all direct-to-consumer advertising for three years, however. There is a waiver in the bill that would allow the ban to be lifted if the drug is determined to have an “affirmative value” to the public health.

Dick O’Brien, EVP of government relations for the American Association of Advertising Agencies, an advertising trade group, said the proposed legislation isn’t a new idea.

“It’s one of several different approaches that opponents of DTC have toyed with over the years in an attempt to limit the amount of that advertising,” he said. “The Supreme Court has ruled consistently in recent years that his type of speech is protected by the First Amendment. It’s our job to remind key lawyers of that forcefully and frequently.”

This is not the first time that DTC has come under attack. Most recently, the American Medical Association voted to support a ban on the longtime marketing tactic.

DTC advertising has long been seen as problematic by some physicians and patient organizations. Critics have argued that DTC increases adoption of newly approved drugs, which may have safety risks and that such advertising needs to reined in until the drugs are more widely understood outside of clinical trials. They have also argued that DTC leads to unnecessary drug spending if patients, spurred by TV ads, seek new medicines that they might not actually need.

All Western countries, except the US and New Zealand, do not permit DTC advertising.

While a DTC ban has never passed the House or Senate, the industry has attempted to police itself—adopting a voluntary moratorium in the first six months after a drug is approved.

The Pharmaceutical Research and Manufacturers of America, in its 18 guiding principles on DTC, tells its member companies to “spend an appropriate amount of time” focusing on professional education of a new medicine before launching a DTC campaign aimed at consumers. Some drugmakers, too, have adopted this idea. In August, Sprout Pharmaceuticals, which developed hypoactive sexual desire disorder pill Addyi, said it would not advertise the drug on radio or television for the first 18 months following its approval in August.

Those PhRMA principles were established in 2009—one year after Congress took phama to task over TV drug ads for Pfizer’s Lipitor, Merck’s Vytorin, and Johnson & Johnson’s Procrit, which Rep. Bart Stupak (D-MI) described at the time as using “potentially misleading and deceptive tactics.” In addition, lawmakers took issue with drugmakers promoting new treatments that didn’t demonstrate they improved clinical outcomes—such as Vytorin—and the use of an artificial heart inventor, Dr. Robert Jarvik, to promote cholesterol-lowering blockbuster Lipitor. Pfizer used a body double in a TV ad (pictured below) when Jarvik is rowing across a lake.

PhRMA spokesperson Holly Campbell defended DTC in an email, saying that conversations about it “are being driven by the false notion that DTC plays a direct role in the cost of new medicines and ignores the positive impact of healthcare communications.”

The industry’s stance maintains that DTC is beneficial to the public because it increases patient awareness about new treatments and, as a result, helps people become more involved in their own health.

A survey conducted by the FDA, and pointed out by Campbell, largely backs up that stance. In 2004, the agency found that DTC increases patient awareness of conditions with more than half of doctors surveyed saying that it led to better discussions about patients’ health.

However, the same survey also found that greater awareness about a disease or condition does not necessarily equal better understanding. While patients reported recognizing both the benefits and risks at the same rate, doctors said they believe that “patients understand the benefits much better than the risks.”

Drugmakers spent $4.5 billion on DTC in 2014, according to Nielsen.