PHARMACEUTICAL INDUSTRY ISSUES DTC AD GUIDELINES

Softball Approach Rejects Calls for Restrictions or Moratorium

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NEW YORK (AdAge.com) -- The Pharmaceutical Research Manufacturers of America released its voluntary code of conduct for the $4 billion direct-to-consumer advertising industry, calling for a better presentation of risk information and Food and Drug Administration pre-approval of all advertising, but falling well short of a mandate on the most serious issues.

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'Guiding Principles'
The trade group made the formal introduction of its "Guiding Principles" at the American Legislative Exchange Council's annual meeting in Dallas.

There are no restrictive features in the 15-point code of conduct, and it does not implement several measures called for by critics, including a one- or two-year moratorium on ads following a product's approval by the FDA -- something Bristol-Myers Squibb has already self-imposed -- and a tenet that would limit erectile dysfunction drug ads on TV to between 10 p.m. and 6 a.m.

Soft language
Rather, it addresses both in far softer language. Instead of putting a specific time-frame ban on brand advertising following FDA approval, PhRMA's No. 6 guideline calls for drug companies to "spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign. In determining what constitutes an appropriate time, companies should take into account the relative importance of informing patients of the availability of a new medicine, the complexity of the risk-benefit profile of that new medicine and health care professionals’ knowledge of the condition being treated."

And instead of limiting ED drugs to late-night television, point No. 13 states that "In terms of content and placement, DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved."

Yet PhRMA's chairman, William Weldon, also the CEO of Johnson & Johnson, said the code of conduct “goes well beyond” current FDA regulations regarding advertising and promotion.

Former Congressman Billy Tauzin PhRMA President Billy Tauzin, a former U.S. Congressman, said that 23 drug companies approved the code of conduct. PhRMA has tried for years to implement a code of conduct for DTC advertising only to meet with resistance, for one reason or another, from its various members. Mr. Tauzin assumed leadership of the organization earlier this year and announced in May that he wanted the group's members to adhere to the advertising guidelines as part of an overall effort to restore faith in the battered industry. And despite the intense scrutiny from the FDA, Congress and some sectors of the general public, PhRMA was able to go from Mr. Tauzin's original announcement to producing a discussion guide to a vote among its board of directors to today's formal announcement all in three months.

Still, some of the principles are already drawing internal debate. One of the principles, No. 10, bans reminder ads, which are usually 15-second spots that identify a product by name but do not have to include risk information.

“It was a close debate by our board of directors,” Mr. Tauzin said, “but they agreed that reminder ads don’t serve the purpose of education. They ought to go; they’re gone.”

Ridiculous and short-sighted
“Ridiculous,” sniffed one marketing chief at a major pharmaceutical company. Said another: “It’s one thing for them to say they don’t want an unbranded, disease-awareness ad followed by a reminder ad. But to ban reminder ads altogether is short-sighted.”

Almost immediately, advocacy groups on both sides began weighing in. The New York-based Coalition for Healthcare Communication applauded the principles and urged the FDA and Congress -– both of which have been critical of DTC advertising -- to halt additional regulations “until the industry and policy makers have experience with these new principles and the specific steps taken by leading drug companies,” said John Kamp, the group’s executive director.

Gary Ruskin, executive director of Portland, Ore.-based Commercial Alert, called PhRMA’s code of conduct an act of “craven self-preservation,” and said the industry learned nothing in the last year except the need for better public relations.

“Americans agree with Senate Majority Leader [Bill] Frist that it’s time for drug companies to clean up their act,” Mr. Ruskin said. “But PhRMA’s new ‘guiding principles’ makes it clear that they won’t do it. So, now it’s time for Congress and the FDA to step in.”

The possibility that Congress and/or the FDA could impose its own regulatory measures still exists.

Mr. Frist, a Republican senator from Tennessee who is also a physician, twice last month blasted the industry's DTC practices. On July 1 he called for drug makers to voluntarily follow Bristol-Myers Squibb's lead and put a moratorium on advertising for at least two years following approval of a drug. In a July 25 speech in San Francisco, Mr. Frist again called for the FDA to have more authority when it comes to DTC and suggested that the rising cost of prescription medication is related to what he called "mindless drug advertising."

Ads that 'suggestively overpromise'
"Turn on your TV, and within 15 minutes you'll be bombarded by dreamy ads that suggestively overpromise and, even more likely, will make you and your children experts on erectile dysfunction," he said. While acknowledging that drug advertising has its salient points, Sen. Frist added, "We must ask ourselves: 'Are these ads, which we know are costing billions, properly educating patients or just peddling expensive products?' "

The industry spent $4 billion on drug advertising last year, according to TNS Media Intelligence; PhRMA estimated that just its members alone spent more than $38 billion in 2004 on research and development.

Mr. Weldon said he expects member companies to have the principles factored into their advertising by the end of the year.

Office of accountablity
In addition to announcing the code of conduct, PhRMA also promised to enforce the guiding principles with a variety of means. First, each drug company's intention with regard to the guiding principles will be made public. PhRMA will establish an office of accountability that will be responsible for receiving comments from the general public and from healthcare professionals regarding DTC advertising conducted by any signatory company to these principles. Any company that publicly states that it will follow the principles will be considered a signatory company.

The PhRMA office of accountability will issue periodic reports to the public regarding the nature of the comments and the signatory companies’ responses, and will provide a copy of each report to the FDA.

One year after the effective date of the principles, the PhRMA office of accountability will select an independent panel of credible individuals to review reports of that year, to track the overall trends in the industry as they relate to the principles, and to make recommendations in accordance with the principles. The panel’s report will be included in the next report of the PhRMA office of accountability.


TEXT OF PhRMA Principles Statement

PhRMA Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines

To express the commitment of PhRMA members to deliver DTC communications that serve as valuable contributors to public health, PhRMA has established the following voluntary guiding principles.

1. These Principles are premised on the recognition that DTC advertising of prescription medicines can benefit the public health by increasing awareness about diseases, educating patients about treatment options, motivating patients to contact their physicians and engage in a dialogue about health concerns, increasing the likelihood that patients will receive appropriate care for conditions that are frequently under-diagnosed and under-treated, and encouraging compliance with prescription drug treatment regimens.

2. In accordance with FDA regulations, all DTC information should be accurate and not misleading, should make claims only when supported by substantial evidence, should reflect balance between risks and benefits, and should be consistent with FDA approved labeling.

3. DTC television and print advertising which is designed to market a prescription drug should also be designed to responsibly educate the consumer about that medicine and, where appropriate, the condition for which it may be prescribed.

4. DTC television and print advertising of prescription drugs should clearly indicate that the medicine is a prescription drug to distinguish such advertising from other advertising for non-prescription products.

5. DTC television and print advertising should foster responsible communications between patients and health care professionals to help patients achieve better health and a more complete appreciation of both the health benefits and the known risks associated with the medicine being advertised.

6. In order to foster responsible communication between patients and health care professionals, companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign. In determining what constitutes an appropriate time, companies should take into account the relative importance of informing patients of the availability of a new medicine, the complexity of the risk-benefit profile of that new medicine and health care professionals’ knowledge of the condition being treated. Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources.

7. Working with the FDA, companies should continue to responsibly alter or discontinue a DTC advertising campaign should new and reliable information indicate a serious previously unknown safety risk.

8. Companies should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast.

9. DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition.

10. DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.

11. DTC television and print advertising should be designed to achieve a balanced presentation of both the benefits and the risks associated with the advertised prescription medicine. Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.

12. All DTC advertising should respect the seriousness of the health conditions and the medicine being advertised.

13. In terms of content and placement, DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved.

14. Companies are encouraged to promote health and disease awareness as part of their DTC advertising.

15. Companies are encouraged to include information in all DTC advertising, where feasible, about help for the uninsured and underinsured.

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