INDUSTRY'S ABILITY TO MONITOR DTC ADS QUESTIONED
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 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.
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. "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.
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 recent 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.
To view PhRMA's code on DTC ads, access http://www.phrma.org (http://www.phrma.org).