New Drug Advertising Rules
Pharmaceutical Giants Agree to Delay Consumer Ads for New Products
Congressional pressure has forced several pharmaceutical giants to delay consumer advertising of new prescription drugs for six months while they evaluate their use and educate doctors on the promises and potential side effects of the new products.
The agreement continued a series of advertising setbacks for the drug industry, which may also impact the television industry. The setbacks mean consumers may not see as many of those "ask your doctor" commercials which have flooded the channels since the companies won approval in 1997 to advertise directly to viewers.
Nielsen Monitor-Plus reported that drug companies spent $5.4 billion on TV commercials in 2007. It is not known how much that volume will be impacted by the six-month agreement..
Pharmaceuticals Agree to Ad Delay
In June 2008, Merck, Johnson & Johnson, Schering-Plough and Pfizer wrote letters to the House Energy and Commerce Committee agreeing to the six-month moratorium on advertising new drugs. According to AdAge, the companies also agreed to limit the use of doctors in their commercials and not to use actors to portray doctors.
Committee Chairman John Dingell and Representative Bart Stupak, both Michigan Democrats, had asked the companies to delay new drug advertising for two years.
The Congressmen said they "appreciated the companies' willingness to change some of their business practices," but Stupak added the firms had not agreed to other requests that would "protect consumers from misleading and deceptive advertising."
Drug advertisers were already required to list all the potential side effects of their medications. To laymen, those lists sometimes sounded as bad as the ills the drugs were designed to treat.
John Edwards Called for Two-Year Moratorium
The firms’ agreement to the six-month voluntary moratorium was seen as an attempt to hold off tougher government controls on drug advertising. It followed on the heels of several recent advertising setbacks for the industry.
Former North Carolina Sen. John Edwards advocated a two-year moratorium on the new product advertising in October 2007 during his unsuccessful presidential campaign.
"I think two years makes sense," Edwards told the Associated Press. "It gives enough time for a drug not just to have been tested in clinical trials but to be out among the public, to see what kind of adverse reactions there have been." He accused the industry of producing misleading ads.
The two-year moratorium has been recommended for several years. Senate Majority Leader Bill Frist, a Tennessee Republican physician, called for it in 2005.
Merck Agreed to Vioxx Settlement
In May 2008, Merck agreed to pay $58 million to settle a suit claiming it had used deceptive advertising for Vioxx, a painkiller medicine that it withdrew from the market in 2004. As part of that settlement, Merck agreed to submit all new TV drug commercials to Food and Drug Administration for review and to abide by FDA recommendations on the ads.
Earlier in 2008 the House Committee on Energy and Commerce began investigating Pfizer’s use of Dr. Robert Jarvick in its commercials for Lipitor. Jarvick, who was identified in the commercials as the inventor of the artificial heart, was reportedly paid $1.3 million to promote the drug.
Also, Eli Lilly & Co. agreed to pay over $1.2 billion to settle class action suits growing out of its promotion of Zyprexa, an anti-anxiety drug.
At mid-year, the industry appeared headed for more marketing problems. Lilly faced additional legal challenges and the House committee planned followup meetings with Pharmaceutical Research and Manufacturers of America (PhRMA), which represents drug companies.
In May PhRMA issued a news release saying its members "are committed to providing accurate, educational information to patients and health professionals about their medicines."
References:
- Ira Teinowitz in AdAge.com, June 16, 2008
- The Associated Press, Oct. 28, 2007
- Pharmaceutical Research and Manufacturers of America website
