June 11, 2007

Legislative Activity

June 11, 2007

To: AAF Members

From: Clark Rector Jr., Senior Vice President – Government Affairs
Jeff Perlman, Executive Vice President – Government Affairs

Re: DTC Pharmaceutical Advertising – Urgent Alert

The Health Subcommittee of the House Energy and Commerce Committee is scheduled this week to take up drug safety legislation that would severely restrict truthful pharmaceutical advertising. We need you to contact your member of the subcommittee today and express your concern about the bill.

The commercial speech provisions in the bill include:

  1. A three-year ban on ads for new medications,
  2. Preapproval of advertising content by the Food and Drug Administration,
  3. Mandated warning language about nonspecific, unidentified adverse events,
  4. A mandated warning symbol for all new drugs and
  5. Required preapproval of a medication's marketing plan by the FDA.

The AAF opposes these provisions because they are unconstitutional restrictions on commercial speech and because they would harm consumers by taking away a valuable source of information.

The AAF supports giving the FDA authority similar to that of the Federal Trade Commission to levy fines against pharmaceutical companies for false or misleading advertising. The drug safety bill passed by the Senate (S. 1082) includes this authority.

This is one of the most important advertising issues to be considered by the House in many years. The precedents set by this bill could have implications for countless products beyond pharmaceuticals.

Contact information and talking points are provided below. Please call or e-mail the office of your member of Congress today and express your opposition to the restrictions on commercial speech.

Do not hesitate to contact us if you have any comments or questions. Thank you for your help with this critical issue.

Health Subcommittee Bill Bans and Restricts Advertising

BACKGROUND:The House Energy and Commerce Subcommittee on Health plans to mark up a drug safety bill that contains five restrictions on speech: (1) A three-year ban on ads for new medications, (2) preapproval of ad content by FDA, (3) mandated warning language about nonspecific, unidentified adverse events, (4) mandated warning symbol for all new drugs and (5) required preapproval of a medication's marketing plan by FDA.

We OPPOSEany government BAN on advertising for up to three years or the granting of unprecedented powers to FDA to preclear all advertising content, to require nonspecific warnings of unidentified risks in ads, inclusion of warning symbols that imply that new medications are dangerous and government preapproval of marketing plans, even though FDA has approved the medication.

We SUPPORTgiving the commissioner of FDA authority similar to that used by the Federal Trade Commission to determine in an administrative hearing if advertising is false or misleading and to levy fines against pharmaceutical companies that do not present truthful ads.

REQUEST: We urge the House Energy and Commerce Subcommittee on Health to reject moratoriums on ads, preapproval of ads, mandated speech or warning symbols in ads, preapproval of marketing plans and any other unconstitutional restrictions on advertising.

  • We urge you to support an alternative to advertising in drug safety legislation being proposed by Congressman Frank Pallone. The draft bill may be voted on in the House Energy and Commerce Health Subcommittee as early as Wednesday, June 13, 2007.
  • We urge you to oppose the Pallone bill because it contains five severe restrictions on advertising: (1) A three-year moratorium on ads for new, modified or upgraded medications; (2) preclearance of ad content by FDA; (3) mandatory warnings of unspecified and unidentified adverse events; (4) a warning symbol for all new drugs; (5) FDA pre-clearance of marketing plans for medications.
  • These advertising restrictions would violate the First Amendment protection for commercial speech. The First Amendment rejects prior restraint of speech in favor of seeking penalties if speech is found to violate any laws.
  • There is no evidence that limiting drug advertising will promote drug safety-rather, barring information from advertising will cause more harm to consumers who are not prompted by an ad to see a doctor about an illness. Surveys show that these ads prompted more than 39 million Americans to ask their doctor about a health condition. Current law requires advertising for prescription medications to disclose all major risks, as well as benefits.
  • We urge you to support an amendment that would repeal the ban on advertising and replace it with civil monetary penalties for "false and misleading" advertising. We support the action taken by the United States Senate to reject severe restrictions on speech and instead to give FDA authority to fine false and misleading ads.
  • The most important safeguard is with our physicians-no one can get a drug without a doctor's examination and written prescription.