Statement of Congressman John D. Dingell, Chairman
Committee on Energy and Commerce

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS HEARING ENTITLED, "DIRECT-TO-CONSUMER ADVERTISING: MARKETING, EDUCATION OR DECEPTION?"

May 8, 2008

Below is the prepared statement from Rep. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, for a Subcommittee on Oversight and Investigations hearing titled “Direct-to-Consumer Advertising: Marketing, Education or Deception?”

Mr. Chairman, thank you for holding this important hearing on the risks of direct-to-consumer advertising of drugs.

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. Direct-to-consumer or “DTC” advertising of new drugs has been particularly problematic for new drugs that may lack a broad safety record.

About 10 years ago, the Food and Drug Administration (FDA) relaxed its rules for direct-to-consumer advertisements of prescription drugs, making the U.S. one of only two countries in the world that allow such marketing. Since then, Americans have witnessed a flood of DTC ads, particularly on television.

In fact, spending by drug companies on DTC ads has grown exponentially since 1999. And it is no wonder—research shows that for every $1 spent on DTC advertising, up to a $6 increase in drug sales result.

The drug industry asserts that these drug ads benefit the public health by educating both consumers and physicians about disease and potential drug therapies. As we explore the risks and benefits of DTC advertising, however, it is worth noting the words of a former New England Journal of Medicine editor who said drug companies were “no more in the business of educating the public than a beer company is in the business of educating people about alcoholism.”

Nevertheless, drug advertising can indeed serve an educational role, provided drug companies scrupulously adhere to FDA guidelines for DTC ads. FDA guidelines and regulations require that direct-to-consumer ads must:

· be accurate and not misleading;

· make claims only when supported by substantial evidence;

· reflect balance between risks and benefits; and

· be consistent with FDA-approved labeling.

Regrettably, investigations by this Committee have revealed systematic violations of these principles by a number of drug companies. Some ad campaigns have been misleading and others appear downright deceptive.