June 24, 2003

Legislative Activity


Date: June 24, 2003

To: AAF Club Members

From: Jeff Perlman, EVP-government affairs

Re: URGENT Threat to DTC Pharmaceutical Advertising


PLEASE Call Your U.S. Senators IMMEDIATELY to Oppose Senator Edwards (D. N.C.) and Senator Harkin's (D. IA.) Amendment That Would Eliminate Broadcast Advertising of Prescription Drugs.

Senators John Edwards (D-NC) and Tom Harkin (D-IA) today introduced an amendment to the Prescription Drug and Medicare Improvement Act of 2003 that effectively would eliminate broadcast advertising of prescription drugs. The amendment is expected to be voted on in the United States Senate within hours or days.

It is critical that you call or, at the minimum, e-mail your U.S. Senators immediately and ask them to vote against this anti-advertising amendment.

The amendment would reduce public access to information about diseases and their treatments by overwhelming audiences with so much detail that no understandable information will get through to consumers. It would require so much information that it would effectively prohibit any direct to consumer advertising whether in print or on radio or television.

The sponsors know that no advertisement can provide consumers with all the information they need to evaluate a particular prescription drug. Who will suffer from this requirement — the consumer. There will be fewer, if any, ads in the future, and thus far less information reaching Americans about their own health. Less often is more when encouraging consumers to respond an advertisement. Rather than trying to tell them everything that has been published about a particular drug, it can be far more effective to tell them that an advertised drug has side effects, and they should consult their doctor. After all, they cannot get the advertised drug without their doctor's prescription.

The amendment would require a pharmaceutical company to prepare and provide a totally new body of findings and information about a prescription drug that compares the drug to all other drugs on the market designed to treat the same condition. The company would be required to present a "fair balance" comparable in depth and detail about the effectiveness of the drug, it effectiveness comparable to all similar drugs, and information relating to contraindications and side effects.

Instead of the "fair balance" required by FDA under current law, this amendment would require pharmaceutical companies to present a "perfect balance" in their ads. In this instance, the perfect would become the enemy of the good. The requirements of the Edwards-Harkin amendment would transform an advertisement into an encyclopedia. Like most encyclopedias, it would go unread.

There simply would be no practical way to implement this new "perfect balance" requirement in order to provide comparative information in broadcast advertising. A law or regulation that places such an impossible burden on speech would hardly stand the test of the First Amendment and its protection for commercial speech.

The new standards would require:

  • Not just fair balance but a "perfect balance" between messages about safety and effectiveness, because it would have to be comparable in depth and detail as between safety and effectiveness.
  • The manufacturer to provide comparative effectiveness information between its product and all other comparable products.

Example: Manufacturer of a prescription drug for the treatment of migraine headaches would likely have to provide in all of its advertising comparative information about its drug relative to all the others in the category — there are six major drugs in the migraine category. Since current law requires effectiveness claims to be supported by two adequate and well controlled tests, the amendment would appear to require the advertiser to prepare 12 studies to compare its drug against each of its five competitors.

Below, please find additional "talking points" that you might wish to utilize. Please visit www.senate.govfor your Senator's e-mail address or you can obtain their e-mail addresses by calling the Capitol switchboard at (202) 225-3121.

I would appreciate hearing of anything you learn as a result of your communications.

Thank you.

Talking Points To Oppose Anti-Public Health Information Amendment

  • Senators Edwards and Harkin have offered an anti-advertising amendment to the Medicare prescription drug bill before the Senate.o We urge you to oppose this amendment.
  • The amendment will restrict consumer access to public health information because it effectively will eliminate broadcast advertising of prescription drugs. It would do this by requiring that ads to include more information than reasonably could be aired or possibly even printed.
  • Thus, even though Prevention Magazine and the FDA reported that more than 23 million Americans who saw a prescription drug ad went to a physician to discuss a condition they never before had discussed, in the future those millions of Americans will have to get their information from another source, and that means they probably will not be prompted to see a doctor about an undiagnosed condition.