Significant restrictions on direct-to-consumer drug advertisements are needed to protect U.S. consumers, House Democrats said during a May 8 Energy and Commerce Oversight and Investigations Subcommittee hearing.

If ads for Vytorin (ezetimibe/simvastatin), Lipitor (atorvastatin calcium), and Procrit (epoetin alfa) “are indicative of typical DTC ad campaigns, it appears that we need to enforce significant restrictions on DTC ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies,” subcommittee Chairman Bart Stupak (D-Mich.), said. “Research has shown that DTC advertising may result in advertised drugs being prescribed when a similar, less-expensive drug may have been just as appropriate.”

Specifically, Stupak said the ads for Pfizer's cholesterol drug Lipitor, Merck/Schering-Plough's cholesterol drug Vytorin, and Johnson & Johnson's anemia drug Procrit are “three examples of drug companies acting improperly.”

Pfizer's Lipitor ad featured Robert Jarvik, who never held a license to practice medicine and who never has been allowed to prescribe medicine, Stupak said. He was paid $1.35 million for appearing in the ads; however, none of the ads indicated that he was compensated for his appearance.

The Lipitor ads are “in violation of the American Medical Association's guidelines concerning the involvement of health professionals in DTC advertisements,” Stupak said.

While Vytorin ads were airing, the release of a study examining Vytorin's ability to stop cholesterol build-up was “delayed and suppressed” by Merck and Schering-Plough, Stupak said. The study was delayed for two years while Vytorin was marketed to consumers.

“We now know that Vytorin has no effect on cholesterol build-up,” Stupak said. “Many consumers may not have taken Vytorin had they been aware of the study results, especially since a less expensive, equally effective generic drug, Zocor, was already available.”

“In addition, taxpayer dollars may have been needlessly spent on Vytorin through Medicare Part D as the drug was marketed to consumers while the company sat on its study results,” Stupak said.

Although Procrit was approved by the Food and Drug Administration only to treat chemotherapy-induced and dialysis-induced anemia, it was marketed for the treatment of cancer fatigue in order to improve the quality of life for patients, Stupak said. “This was clearly an instance of off-label marketing--a practice that is prohibited by FDA.”

Stupak pointed out that while drug companies must submit copies of their ads to FDA's Division of Drug Marketing, Advertising, and Communications, no preclearance is required before the ads can air.

“If a DTC ad is found to be in violation of FDA regulations, FDA can issue written letters for serious violations, which may lead to regulatory action by FDA,” Stupak said. “However, if a company refuses to comply, FDA cannot impose fines except through an administrative hearing.”

Rep. John Shimkus (R-Ill.), ranking member of the Oversight and Investigations Subcommittee, however, pointed out that the FDA Amendments Act gave FDA power to impose civil fines on companies when DTC ads are false or misleading. “This provision just went into effect one month ago,” he said. “I wonder if this is the appropriate time to be debating these issues.” The ad campaigns for Vytorin, Procrit, and Lipitor aired before FDAAA, he added.

FDAAA also created the Reagan-Udall Foundation to allow for post-market surveillance, Rep. Michael C. Burgess (R-Texas), said. However, funding for the foundation was denied in the final appropriations bill for fiscal year 2008, “which I don't understand.” The foundation “would answer some of the questions we have here today,” Burgess said.

Burgess also said that he doesn't see the problem with the Lipitor ad. There is “no question that introduction of statins has made a big impact on heart disease in this country,” Burgess said. There have been “significant savings to Medicare because of the introduction of these types of medications.” he added.

“In the wake of revelations concerning the safety problems surrounding widely advertised drugs such as Vioxx and Ketek, we must ask how well the policies that govern direct-to-consumer advertising are serving the American people,” Energy and Commerce Committee Chairman John D. Dingell (D-Mich.) said.

“Congress must ensure FDA has the authority and resources to effectively monitor whether drug companies are properly marketing their products in compliance with the law,” Dingell said. “DTC advertisements may well serve an educational purpose, but they are primarily designed to sell products.”

Rep. Henry A. Waxman (D-Calif.), chairman of the Committee on Oversight and Government Reform, said that, while he is concerned about DTC advertisements, he is more concerned about drug company advertising to physicians, a practice that is “outside of public view.”

AMA Supports FDA Review of Ads.

The American Medical Association “supports FDA review and approval of all DTC ads and adequate funding to perform these activities,” AMA President-elect Nancy H. Nielsen said in written testimony.

Nielsen said the AMA does not believe that FDA has adequate resources to carry out its enforcement role over DTC ads since the staffing has not kept pace with the increase in these ads.

AMA also supports a moratorium on DTC ads for new drugs until physicians have been educated about the drug. “The length of this moratorium may vary from drug to drug and should be determined by FDA in negotiations with the manufacturer,” Nielsen said.

Drug Industry Defends Ads.

“Regarding direct-to-consumer television advertising, Pfizer is committed to responsible advertising that anticipates and addresses the needs of patients and doctors,” James T. Sage, Pfizer's senior director/team leader of Lipitor, said in written testimony.

“We use DTC [ads] to increase awareness of our products, to educate consumers about the conditions that they treat and to increase patient and physician discussion about those conditions,” Sage said.

Sage also said that there is “substantial” evidence that DTC advertising “educates consumers and motivates them to: seek additional information about their medical condition and corresponding treatment options; consult their physicians for diagnosis and appropriate treatment; and follow the treatment plans directed by their physicians.”

“Statins, including Lipitor, have played an important role in addressing the risks of heart disease when diet and exercise alone are not enough,” Sage said. “Pfizer asked Dr. Jarvik to appear in Lipitor advertisements because he is recognized for his work related to the human heart.”

Sage pointed out that Jarvik received his doctorate degree from the University of Utah College of Medicine in 1976 and while not a practicing physician, his entire career was devoted to medical science related to the human heart. “Both Pfizer and Dr. Jarvik are confident that the statements included in the ads fairly represent the scientific data about Lipitor,” Sage said.

The statements in the ads about the benefit of Procrit were “true, responsible, and substantiated by scientific studies showing that administration of Procrit led to significant improvements in the symptoms of anemia in chemotherapy patients,” Kim Taylor, president of Ortho Biotech, a division of Johnson & Johnson, said in written testimony.

Taylor also said that the ads were consistent with the FDA-approved indication for Procrit and the ads began five years after Procrit was approved. Ortho Biotech also submitted the ads to FDA as required by regulations and the company had “extensive and ongoing discussions with appropriate FDA officials” about the ads, Taylor said.

The Vytorin ads “used an effective approach to educate patients about the importance of lowering cholesterol, the two sources of cholesterol, the importance of diet, and the additional LDL lowering that can come from drug therapy when a healthy diet is not enough,” Deepak Khanna, senior vice president and general manager, Merck/Schering-Plough, said.

“These advertisements only made claims that were supported by research, that were evaluated by the Food and Drug Administration, and that were consistent with our FDA-approved labeling,” Khanna said. “In developing the advertising campaign, we sought advice from the FDA on the proposed content of our advertisements and revised them in response to those comments.”

GAO Report.

During the hearing, the Government Accountability Office released a report on FDA's oversight of DTC advertising, saying that delays in issuing regulatory letters limit FDA's effectiveness in overseeing such advertising and in reducing consumers' exposure to false and misleading advertising.

“By the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising material identified in each letter,” the report said. “In addition, FDA's issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”

In 2006, GAO found that FDA reviewed a small portion of the DTC materials it received, and the agency could not ensure that it was identifying for review the materials it considered to be high priority. At that time, GAO recommended that FDA apply criteria for prioritizing its reviews of DTC advertising materials.

In May, FDA indicated that it had documented criteria to prioritize reviews. However, FDA “still does not systematically apply its criteria to all of the DTC materials it receives,” GAO said.

In its 2006 report, GAO also recommended that FDA track which DTC materials had been reviewed; however, in May, the agency said it still did not track this information, GAO said. “As a result, the agency cannot ensure that it is identifying and reviewing the highest priority materials.”

By Bronwyn Davis

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More information about the hearing is available on the Web at http://energycommerce.house.gov/membios/schedule.shtml.

GAO's report is available at http://www.gao.gov/new.items/d08758t.pdf.

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