Drug Industry Daily, August 4, 2005

Two powerful Republican senators have expressed skepticism about the drug industry's ability to self-regulate its direct-to-consumer (DTC) advertising practices under PhRMA's new code of conduct.

PhRMA's guiding principles on DTC ads, announced Aug. 2, acknowledge the need for greater transparency when it comes to drug safety, said Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee. "But it doesn't deliver a single guarantee for consumers," he added.

Among other things, PhRMA's 15-point code calls on drugmakers to: Target their DTC ads at age-appropriate audiences; Provide a balanced presentation of risks and benefits; Submit all television ads to the FDA before airing them; Spend an "appropriate amount of time" educating health professionals about a new drug or indication before beginning the first DTC ad campaign; and Stop running "reminder ads" that mention the drug's brand name but not the disease condition that it treats (DID, Aug. 3, Page 5).

The PhRMA board unanimously approved the code, and 23 companies have signed on to date. Pfizer said it strongly supports the DTC advertising principles and is especially pleased with the "unambiguous commitment" to better meet patients' needs with improved communication of risk and benefit. Amgen said the voluntary principles recognize the role DTC advertising can play by increasing awareness about diseases, educating patients about treatment options and motivating patients to contact physicians.

But Grassley argues the principles do not go far enough. The FDA should start exercising its authority to closely monitor the marketing of pharmaceuticals, he said."In addition to a dramatically stepped up effort by the FDA, we need an updated law that requires drugmakers to submit their ads to the FDA for review," he said. In April, Grassley and Sen. Christopher Dodd (D-Conn.) introduced legislation, S. 930, that would require firms to do just that, as well as require new disclosures in ads for new drugs and those that present higher risks (DID, April 28, Page 1).

"It doesn't make sense to rely on drug companies to police themselves," Grassley said.Senate Majority Leader Bill Frist (R-Tenn.), another prominent critic of DTC advertising, welcomed PhRMA's acknowledgement that DTC advertising "is badly in need of reform.

"In recent speeches, Frist alleged that DTC ads are unbalanced and drive up drug costs. He has called on the industry to adopt a two-year moratorium on advertising following the approval of a new drug (DID, July 5, Page 1).

"While I wish the PhRMA guidelines would have gone farther and proposed a moratorium on DTC advertising of newly approved drugs, I hope individual pharmaceutical manufacturers will seriously consider such a measure," Frist said.

He plans to closely monitor the industry's efforts to self-regulate, as well as the FDA's announced plans to review agency guidelines on DTC advertising. "I'm heartened by this recent progress and I will continue to evaluate whether legislative remedies are necessary to put patient safety first and help control prescription drug costs," Frist said.

Meanwhile, PhRMA President and CEO Billy Tauzin said the new code goes beyond current federal regulations and addresses Frist's concerns. "We want to thank Sen. Frist for what I consider to be a huge effort to create a momentum that has lead to this day," Tauzin said at an Aug. 2 event unveiling the code.

Tauzin rejected the need for new federal regulations and noted that voluntary industry codes, especially those governing a free speech issue, can be effective. For example, he and other PhRMA leaders pointed to a 2002 voluntary code on the drug industry's relationship with physicians and other healthcare professionals. A number of longstanding marketing and sales practices were modified or actually ended through that code, said Karen Katen, vice chairman of Pfizer and president of Pfizer Human Health.

Healthcare professionals broadly welcomed these changes, she said. "We believe we can achieve something similar with our new DTC guiding principles," Katen said. Ensuring compliance with the code will be achieved in part through a new independent panel that will review comments from the public about DTC campaigns, Tauzin said. The panel will track overall DTC ad trends and make recommendations to industry, he added."Quite simply, the independent panel will assess how well we are doing to live up to our commitments," Tauzin said, adding these assessments will be made public.

PhRMA also will issue periodic reports on the comments received from the public and company responses, he noted. "Through these approaches, we aim to demonstrate that we really mean what we say," he said.

One prominent industry observer believes PhRMA's voluntary guidelines will succeed. "It is in the best interest of industry to see them work," said Peter Pitts, senior vice president in the Global Health Affairs practice of the public relations firm Manning Selvage & Lee. Pitts also was former associate commissioner for external relations at the FDA.

"If they do not work, or if they begin to hedge or 'kind of sort of do it,' then more draconian things will start to happen, either via Capitol Hill or the FDA," Pitts told DID. "The fact that you're dealing with very touchy First Amendment issues does not mean that regulations could not be considerably more onerous than they currently are.

"The most significant guideline is the one that prohibits reminder ads, said Pitts, who welcomed the change. "Reminder ads send the wrong message and do not advance the public health," he said. "They are 100 percent a marketing tool and zero percent a public health tool.

"Other industry observers contend firms will still have plenty of leeway to interpret the guidelines. Principle 6 on educating physicians before the first DTC ad runs, for example, does not guarantee that health officials will get real world experience with a drug before the ad appears, said John Mack, owner of the Pharma Marketing Network, which includes an online forum of pharmaceutical marketing, advertising and sales professionals.

Typically, drugmakers do a lot of physician education before a drug is launched, said Mack in the forum. "The whole idea of a DTC moratorium is to limit DTC after launch," he noted. "That way physicians -- educated or not -- and public health agencies and [the] FDA can get some real world experience with the drug.

"Tauzin described the physician education guideline as the "centerpiece" of the guiding principles. "Running a DTC ad before we have properly educated the healthcare professional about a new medicine is a mistake," he said. But Tauzin rejected a set timeframe. "People have called for six months, a year, two years' time," Tauzin said. "What we're saying is that this ought to be medicine-specific: more time for the complex medicines, less time for the simple; less time for the medicines that need to get out quickly to patients, perhaps more time for medicines that can wait."

To view PhRMA's code on DTC ads, access http://www.phrma.org.