The long-awaited code of conduct issued last week by a pharmaceutical industry looking to head off government-imposed regulation on direct-to-consumer drug advertising is seen by many as wishy-washy by design, and a mere starting point to bargain for bigger chips.
"I don't believe that what we saw [last] week will be the final set of guidelines the industry will be operating under a year from now," said a marketing executive who works for one of the 23 pharmaceutical companies that signed off on the code for the Pharmaceutical Research and Manufacturers of America.
"There's going to be a happy medium," agreed one health-care-agency president. "PhRMA's guidelines are soft. The government will likely come down hard."
Faced with political and consumer backlash against DTC, PhRMA came up with 15 guidelines for the marketing of prescription drugs. Though the code, which was first reported by Advertising Age, did ban the 15-second reminder ads in which companies do not have to provide risk information, it was generally considered to be toothless.
Worse, critics don't like the idea of the industry self-regulating.
"It doesn't make sense to rely on drug companies to police themselves," Sen. Charles E. Grassley, R-Iowa, said in a statement. Mr. Grassley, one of the outspoken critics of drug companies, added that the Food and Drug Administration needs to "start exercising its authority to closely monitor the marketing of pharmaceuticals."
That appears to be on the horizon. The FDA is close to publishing a notice in the Federal Register for a public hearing on drug advertising, a hearing that could lead to more restrictive regulations. But the FDA has also gone down this path before, holding a public hearing as recently as September of 2003 but issuing only three draft guidelines that reduced the brief summaries in print ads and encouraged more disease awareness campaigns.
Whether Congress or the general public can pressure the FDA to come up with stricter regulations remains to be seen. Peter Pitts, a former FDA associate commissioner who is now part of the health-care practice at Manning, Selvage & Lee, New York, said he didn't think the PhRMA code was a calculated move. "The industry realizes that many of its more aggressive marketing tactics have been deliterious to both their own interests and the public health," he said. "As far as congressional action is concerned, while the bully pulpit is an important and powerful tool, First Amendment protection is even more puissant."
Road to the code
This year’s Ad Age headlines document the industry’s journey
Jan. 3 Code red for DTC
March 28 J&J stance on DTC ads irks rivals
April 11 FDA ruling threatens DTC dollars
April 25 FDA scrutiny threatens DTC media bonanza
May 16 DTC lobby scrambles to head off FDA guidelines
June 20 DTC rift as Bristol ban breaks ranks
Aug. 2 Pharmaceutical industry issues DTC ad guidelines