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Professional News
Complaints Lead Drug Firms To Modify Ad Guidelines
Psychiatric News
Volume 40 Number 17 page 1-38

Pharmaceutical industry guidelines stop short of an advertising moratorium, but call on companies to allow “an appropriate amount of time” for education of physicians and the public about new medications.

Leaders in medicine and public policy appear to be underwhelmed by voluntary “guiding principles” on the conduct of direct-to-consumer advertising (DTCA) issued by the Pharmaceutical Research and Manufacturers of America (PhRMA).

PhRMA's Board of Directors approved 15 guidelines to address concerns expressed by APA, the AMA, and public policy officials, among others, about the marketing of drugs to consumers on television and in other media. Such marketing has been criticized for inappropriately raising patients' expectations and contributing to rising drug and health care costs.

PhRMA's guidelines are voluntary, lack any enforcement mechanism, and steer clear of specific proscriptions or prohibitions.

The first of the 15 guidelines states an overarching public health purpose of DTCA: “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 underdiagnosed and undertreated, and encouraging compliance with prescription drug regimens.”

APA leaders and others said that the industry's move to regulate itself is welcome, but much more needs to be done.

“APA believes public policymakers, physicians, patients, and industry must work together to minimize potential negative impacts of direct-to-consumer advertising,” said APA President Steven Sharfstein, M.D., in a statement following release of the guidelines. “We believe PhRMA's principles are a useful starting point and should be considered a floor, and not a ceiling. We also believe there are issues relative to DTCA that have been raised but not yet addressed.”

Among those issues is the possible imposition of a moratorium, or“ quiet period,” following approval of a drug during which companies would abstain from advertising. On that issue, PhRMA's guidelines suggest only that companies should allow “an appropriate amount of time to educate health professionals” before they start marketing to consumers.

Child psychiatrist and APA Trustee David Fassler, M.D., noted that while the issue of physician and patient education is important, more central is that results from day-to-day experience with a drug may differ markedly from those derived from clinical trials; to tout the benefits of a drug to millions through television advertising on the basis of those trials is likely to overinflate benefits and understate risks.

“I'm concerned about the rapid shift from a few thousand patients in carefully controlled trials to millions of patients with multiple comorbidities who are seen and treated in a wide variety of clinical settings,” Fassler told Psychiatric News. “My interest is to give physicians time to gain firsthand experience with new medications as used in actual clinical practice.”

Fassler, who is vice chair of the Section Council on Psychiatry in the AMA House of Delegates, sponsored a resolution at the meeting of the house in June that called on the AMA to study a host of issues around DTCA, including the possibility of an advertising quiet period following initial FDA approval of a drug. The AMA's Council on Science and Public Health will conduct the study.

“The study we requested would look at increased expenditures related to direct-to-consumer advertising, as well as the impact on patient safety and the overall quality of care,” Fassler said.

“I'm glad that the pharmaceutical industry is starting to address these issues, and I think their guidelines represent a useful contribution to the ongoing public discussion,” he continued. “But in my opinion, they don't go far enough, and they don't eliminate the need for enhanced regulatory oversight. First of all, the guidelines are voluntary. They lack any sort of enforcement mechanism. Ultimately, I think we'll see the FDA take a more active role in oversight and regulation of direct-to-consumer advertising.”

APA leaders were not the only ones less than enthusiastic about PhRMA's guidelines. Senate Majority Leader Bill Frist (R-Tenn.), a physician, also said he favored a moratorium on DTCA and urged individual companies to consider such a measure.

Frist reiterated his call for a Government Accountability Office study of the effects of DTCA.

PhRMA said it will establish an Office of Accountability responsible for receiving comments from the general public and health care professionals regarding DTCA. The office is to issue periodic reports to the public regarding the nature of the comments received and responses by companies that have signed onto the principles and will provide a copy of each report to the FDA, according to PhRMA.

“By formally adopting these guidelines, we are committing to the American people and the medical community that we will use advertising not only to promote new medicines, but also to educate consumers about health and disease,” said William Weldon, chair and CEO of Johnson & Johnson and PhRMA's board chair. “We are saying that we will place a balanced emphasis on the risks as well as the benefits of medicines. Good DTC advertising empowers patients to speak with their doctors, and it helps them make more informed choices about their health and the medicines they take.”

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The following voluntary “guiding principles” for direct-to-consumer advertising were adopted by PhRMA:

  • 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.

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

  • 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 nonprescription products.

  • 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.

  • 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.

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

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

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

  • 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 it.

  • 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.

  • All DTC advertising should reflect the seriousness of health conditions and the medicine being advertised.

  • 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.

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

  • Companies are encouraged to include information in all DTC advertising when feasible about help for the uninsured and underinsured.

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  • 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.

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

  • 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 nonprescription products.

  • 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.

  • 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.

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

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

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

  • 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 it.

  • 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.

  • All DTC advertising should reflect the seriousness of health conditions and the medicine being advertised.

  • 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.

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

  • Companies are encouraged to include information in all DTC advertising when feasible about help for the uninsured and underinsured.

  • PhRMA's DTCA principles are posted at<www.phrma.org/publications/policy//admin/2005-08-02.1194.pdf>.

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