June 16, 2003

Legislative Activity

Date: June 16, 2003

To: AAF Iowa, New Hampshire, South Carolina and North Carolina Advertising Clubs

From: Jeff Perlman, EVP-government affairs
Clark Rector, Jr., SVP-state government affairs

Re: Possible Senator Edwards' DTC Advertising Amendment

Senator John Edwards (D-NC) is seriously considering an amendment to the Senate Medicare prescription drug bill, reported by the Senate Finance Committee, which would place even greater restrictions on direct-to-consumer prescription drug advertising. Senator Edwards' presidential campaign Web site recently launched a sharp attack on DTC prescription drug advertising. Senator Edwards has called for:

  • New content restrictions on drug ads to require even more disclosures about side effects and cheaper drug alternatives;
  • Doubling FDA resources for enforcing DTC ad rules;
  • Repealing a Bush Administration rule relating to the required review by the FDA General Counsel of any regulatory letters sent to advertisers;
  • Levying of civil fines after due process for violation of federal ad rules.

These proposals would have a chilling effect on the content of prescription drug advertising that could discourage advertisers from using this form of communication with consumers. Prescription drug advertising already is the most heavily regulated form of advertising, and the Edwards' proposal would represent a dramatic setback in the effort to protect commercial speech.

The Senate is expected to take up the Medicare prescription drug bill next week, the same week that the House Ways and Means and House Commerce Committees are expected to markup their versions of Medicare prescription drug legislation.

We urge you and other members of your advertising club to contact Senator Edwards' office and urge him not to offer an amendment further restricting the use of prescription drug advertising. Among the key points you will want to make are:

  • Prescription drug advertising is the most heavily regulated advertising by the federal government.
  • FDA Commissioner McClellan has pledged to increase FDA's oversight of advertising.
  • The civil penalties and content restrictions proposed by Senator Edwards would have a chilling effect on commercial speech and deprive consumers of important public health information.
  • Prescription drug ads are among the most effective ways to inform consumers about risks to their health.

You can contact the senator by visiting his Web site at http://edwards.senate.gov, sending an email to senator@edwards.senate.govor calling (202) 224-3154. We have pasted below an issue brief with more information on the DTC advertising issue. Please do not hesitate to call us at 1-800-999-2231 if you have any comments or questions.


Since the U.S. Food and Drug Administration broadened the ways manufacturers of prescription drugs may deliver their messages through direct to consumer advertising, numerous surveys suggest that more people are being treated for previously undiagnosed diseases, and they are having more informed discussions with their doctors. Yet, some congressional leaders have announced they want to impose financial penalties on consumers and manufacturers for the sale and use of drugs that are advertised to the public.

Prescription drug advertising has launched a public health revolution. It is informing patients more about their health care and it is directly responsible for getting patients to visit their doctors. According to the FDA survey, DTC advertising prompted 27 percent of those who saw the ads — nearly 23 million people — to see a doctor and to talk about a condition they had never discussed.

It is a hidden form of censorship for Congress to make it more expensive for Americans to purchase drugs based on the amount of information they are given about diseases and new forms of treatment for them. It is telling Americans — the less you know about your health, the better!

Advertising raises health awareness and leads to earlier disease diagnosis. Six million Americans suffer from diabetes but have not yet been diagnosed. As many as 56 million Americans have high blood pressure, and yet 18 million are unaware they have this silent killer. Another 8 million Americans know they have high blood pressure but are not taking medication. Advertising can help the U.S. government achieve its goal of increasing from 23 percent to 50percent the treatment rate for the 19 million Americans with depression.

The medical profession is making great use of drug therapies in lieu of surgery or other invasive procedures. Recent research suggests that increased spending on pharmaceutical products is linked to substantial savings in health care costs, particularly through reduced hospitalizations.

DTC advertising is not glossing over the risks. 82% of the respondents to an FDA survey said they remembered information about the risks or side effects. As many as one-third of patients fail to take all of their prescribed medicine. These ads even help remind people to properly use their prescriptions. 33 percent respondents of a Prevention Magazine study said the ads reminded them to have their prescriptions refilled, and 22percent were more likely to take their medicine regularly.

The physician must write the prescription. The FDA approved DTC advertising with the confidence that a doctor must write the prescription after examining the patient and assessing the best treatment. Nevertheless, DTC advertising must be accurate and balanced, and the FDA exercises oversight of these ads.

Insurance companies can safeguard against inappropriate prescribing or overuse of prescription drugs. They determine what drugs to cover under their formularies, whether to use brand-name or generic drugs, and the amounts they will reimburse for drugs.

Prescription drug advertising is constitutionally protected commercial speech, and Americans recognize the value that these messages offer them.