DTC Hearing on the House

The House Committee on Energy and Commerce, Subcommittee on Oversight and investigations today held a public hearing : Direct-to-Consumer Advertising: Marketing, Education, or Deception (don’t you love these hearing titles, I wonder what the outcome will be)

The hearing included witnesses from behavioral science, managed care, AMA and industry. (At the bottom of this posting are links to all statements and the webcast of the hearing)

Some of the opening remarks by Subcommittee Chairman Congressman Bart Stupak included:

Nearly 10 years ago, the U.S. Food and Drug Administration (FDA) relaxed its rules related to direct-to-consumer (DTC) advertisements for prescription pharmaceutical products.

Since then, spending on DTC ads has increased from about $1.1 billion in 1997 to about $4.2 billion in 2005.

This nearly 300 percent increase in DTC ad spending dwarfs the 86 percent spending increase in advertisements to physicians and the 103 percent spending increase in research and development over the same period.

The purpose of the hearing is to examine the potentially misleading and deceptive tactics used in direct-to-consumer (DTC) advertisements (ads) for prescription pharmaceutical products.

Our hearing .. will examine three specific television advertisements: ads for Lipitor featuring Mr. Robert Jarvik, ‘Food and Family’ ads for Vytorin and ‘cancer fatigue’ or ‘quality of life’ ads for Procrit.

Pfizer’s Lipitor ads featured

Mr. Robert Jarvik, an individual

Never Licensed to practice medicine

Paid $1.35 million dollars for the ads (not disclosed)

Only started taking Lipitor two months prior to ads appearing

“These ads are in violation of the American Medical Association’s guidelines concerning the involvement of health professionals in DTC advertisements”

Merck and Schering-Plough’s ads for Vytorin

$5 billion dollars in sales in 2007.
Concerned about Enhance Data (two year delay)

To him a generic Zocor would have been better

Taxpayers spent needless millions on Vytorin via Medicare part D

Johnson & Johnson’s Procrit was approved by FDA to treat chemotherapy – and dialysis-induced anemia.

Marketed directly to consumers for the treatment of ‘cancer fatigue’ in order to improve the ‘quality of life’ for patients. (It should be noted that the Procrit ads were pulled in 1995)

This was clearly an instance of off-label marketing – a practice that is prohibited by FDA.

Not only did the company advertise the drug, but FDA did nothing to stop them.

These are three examples of drug companies acting improperly.

Our goal today is to expose the deceptive and misleading aspects of each of these television ad campaigns, but also those of DTC ads in general.

We also intend to explore better practices for DTC marketing.

It is likely that DTC ads will continue, and pharmaceutical companies may continue using the same questionable practices that were used in these three ad campaigns.

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) is responsible for regulating DTC ads.

Drug companies are required to submit copies of their ads at the same time that they are disseminated, but no preclearance is yet required.

If a DTC ad is found to be in violation of FDA regulations, FDA can issue written letters for serious violations, which may lead to regulatory action by FDA.

However, if a company refuses to comply, FDA cannot impose fines except through an administrative hearing.

“I believe that Congress needs to decide whether the U.S. should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required. “

If the three ads that we will discuss today are indicative of typical DTC ad campaigns, it appears that we need to enforce significant restrictions on DTC ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies.

The opening remarks of the incoming AMA president (Nancy Neilson, MD, PhD included:

Direct to Consumer Advertising (DTCA) has become ubiquitous and neither regulatory oversight nor research on its impact have kept pace. As a result, the American Medical Association (AMA) has serious concerns that DTCA is neither balanced nor educational, may adversely affect physician-patient relationships, and contributes to rising healthcare costs.

She went on to outline what steps the AMA recommends in changes to the DTC process including companies adopting the AMA guidelines for DTCA (see bellow for her full statement)

Molly Ann Brodie, PhD from Kaiser Foundation outlined that the public and physicians have mixed feelings about DTC and she felt that more oversight to ensure accuracy of the advertising was in order.

This is a complicated issue, as thirty second to two minute commercial breaks, don’t allow for any in-depth information given, only to point the way to a physician. There will be more on this to come…..

For a full listing of documents on the hearing and watch the webcast:

Direct-to-Consumer Advertising: Marketing, Education, or Deception

Subcommittee Chairman’s Bart Stupak’s full remarks