April 17, 2007

Legislative Activity

April 17, 2007

To: AAF Members

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

Re: Urgent – Immediate Help Needed

As I told you last week, the Senate Committee on Health, Education, Labor and Pensions will mark up S. 1082 drug safety legislation tomorrow, Wednesday, April 18. The bill as written still contains troubling advertising provisions.

During the consideration of the bill, Senator Pat Roberts, R-Kan., will introduce an amendment that will alleviate the advertising industry's concerns. His amendment strikes the two-year moratorium and mandated speech provisions in S. 1082 and substitutes a requirement that all advertising for prescription medications be submitted to the FDA 45 days in advance of publication or broadcast, and it subjects all television advertising that is determined by the FDA to be false or misleading to civil monetary penalties.

We believe these changes are not only constitutional but will better serve the public in helping to ensure that DTC advertising remains a valuable source of information about pharmaceuticals.

Please call or e-mail your senator's office today and ask him or her to support and co-sponsor the Roberts amendment.I have included talking points and contact information below. Please pass this alert on to other members of your advertising federation and urge them to get involved too.

Thanks you for your assistance with this urgent matter. Do not hesitate to contact me at (800) 999-2231 if you have any comments or questions.

Support the Roberts Amendment to S. 1082

Protect the First Amendment: The Solution Is More Speech, Not Less Speech

ISSUE: The First Amendment debate over drug safety legislation questions whether the secretary/commissioner should be given extraordinary powers to regulate commercial speech in the form of advertising by banning ads for new or modified drugs for up to two years and authorizing the secretary/commissioner to insert warning language in any ad.

  • The First Amendment says "Congress shall make no law…abridging the freedom of speech." While the government can regulate its own speech (security classification) and attempt to prevent the unauthorized disclosure of business secrets (Freedom of Information Act), the remedy for speech that is determined to be false or misleading to consumers is to be applied after the fact. For example, the FTC may issue a cease and desist order and then seek fines to enforce it in court.
  • In Western States Medicalthe Supreme Court struck down a ban on advertising of compounded drugs because it did not directly advance the government's interest, and it was the first and not the last remedy chosen.
  • S. 1082 directly contradicts these principles. It authorizes the secretary to bar speech from the public discourse for up to two years. While the latest draft requires the secretary to consider factors such as the number of affected patients and the seriousness of the drug, the key failure of the bill is the recognition that the ban on speech is based on what FDA does not know, not what it knows—the government would ban speech even though it cannot identify an adverse event to support the ban.
  • This is no different than having the government ban advertising for new cars and trucks—while we suspect that a certain number of new vehicles will experience mechanical failures that result in injury or death, we don't know what those failures will be or whether they will occur. But just in case, should we ban advertising of new vehicles to reduce the number of people who might buy them? I doubt that would get much support.
  • The Roberts amendment strikes from the bill the two-year ad ban, the mandated speech warnings and the pre-submission of ads associated with a drug subject to a risk management strategy.
  • The Roberts amendment ads two new provisions: (1) mandatory submission 45 days in advance of all advertising to FDA for review and comment, but not preclearance; (2) authority for FDA to impose civil monetary penalties for broadcast ads determined to be false or misleading: $150,000 for the first violation and $300,000 for each subsequent violation.
  • The Roberts amendment is consistent with our First Amendment jurisprudence—it does not prevent the speech in advance, rather it provides a remedy to address false and misleading speech.
  • As the Supreme Court has stated on numerous occasions, the remedy is more speech, not less speech.Barring speech means that people will lose an important source of information about a potential new medication—advertising that has to meet FDA standards requiring that it be truthful and provide a fair balance of the risks and potential adverse events that have been identified with a drug.