PhRMA's New Rules on DTC Advertising

PhRMA's principles responded to a problem often cited by the FDA in the past by including a goal that advertisers refrain from using manipulative means to downplay drug risks, such as reading a list of possible side-effects in a television commercial while showing distracting visual scenes that take the viewer's mind off of voice-over warnings.

Addressing the concern voiced by many that DTC advertisements by-pass doctors to create a demand from patients for particular pharmaceutical products, PhRMA's guiding principles include an admonition for manufacturers to dedicate an appropriate amount of time to educating health care providers about their products before beginning advertising. This will allow physicians to speak knowledgably with their patients when asked about the possibility of prescribing a new drug to them. In order to determine what constitutes an “appropriate time amount of time,” companies are advised that they should take into account the relative importance of telling the public the drug is available, health care providers' knowledge about the condition being treated and the complexity of the risk-benefit questions posed by the drug. PhRMA declined to offer more guidance than this to manufacturers because, by doing so, it might delay dissemination of information to the public when no delay was warranted by other concerns such as uninformed medical care providers.

When new information of importance about a drug becomes available, health care practitioners should receive the updated information. If new dangers or concerns are discovered after drug advertisements have begun running, those advertisements should be altered or discontinued, as the situation dictates.

Drug Companies Sign On

Drug companies are asked to submit their proposed advertisements to the FDA for prior approval, something they are not now required by law to do. Currently, drug marketers are supposed to submit their advertisements to the FDA when they first show them, and the agency can comment on them as it sees fit, but there is no prior restraint. If an advertisement that has previously been provided to the FDA is later significantly changed, those changes should also be submitted to the agency.

Television commercials and other forms of DTC advertising should describe alternative means of achieving health goals, where possible. For example, a television commercial could suggest that diet and exercise changes might achieve the same effect as the weight-loss aid it is advertising.

The drugs being advertised should be named along with the condition they are meant to treat. This differs from the FDA's rules, which allow companies to avoid the requirement of listing side effects if their advertisements omit either the name of the drug being promoted or the condition it will treat.

PhRMA's Oversight of the Principles

PhRMA is establishing an Office of Accountability as part of its campaign to self-police the industry's communications to patients. This new office will serve as a comment or complaint center for health care providers and the general public. The Office of Accountability will transmit complaints to the drug manufacturers, receive their responses and publish the results to the public and the FDA. After a year in operation, the Office of Accountability will select an independent panel to review the year's reports to see how the industry performed and to track trends. It will then make recommendations as to any changes that should be made to better promote PhRMA's DTC advertising principles.

Several pharmaceutical companies publicized their acceptance of the new principles soon after the rules were announced. Pfizer Inc. said all its advertisements would be in compliance with the PhRMA guidelines by the end of 2005, if not before. As part of its plan, Pfizer has pledged to allot at least 6 months to physician education before it begins advertising a new product to the public. Pfizer will also discontinue running the type of ads that current FDA rules allow to run without risk information, such as those that state the name of the drug but not the condition it is intended to treat — the “Go ask your doctor about this medicine” TV and print advertisements. Merck & Co. Inc. applauded the new policy that requires submission of advertisements to the FDA for pre-approval, something it has voluntarily done for some time. Even before PhRMA came out with its principles, Bristol-Myers Squibb Co. had instituted a self-imposed 1-year moratorium on DTC advertisements for its new products.

In response to continued scrutiny from the public and from legislators concerned over the effects of direct-to-consumer (DTC) advertising, the Board of Directors of the Pharmaceutical Research and Manufacturers Association (PhRMA) voted this past July 29 to institute what it calls a set of “Guiding Principles” that will extend and augment the current FDA rules for DTC advertisement. These principles will go into effect in January 2006.

Some Highlights

Among the rules that PhRMA will implement are a handful promoting drug manufacturers' cooperation with current law, like truth in advertising regulations. Other examples are those principles requiring medical claims made in DTC advertisements to be based on scientific studies of the product and mandating that commercials and print advertising present balanced information about the risks and benefits of the drug being promoted.

PhRMA's principles responded to a problem often cited by the FDA in the past by including a goal that advertisers refrain from using manipulative means to downplay drug risks, such as reading a list of possible side-effects in a television commercial while showing distracting visual scenes that take the viewer's mind off of voice-over warnings.

Addressing the concern voiced by many that DTC advertisements by-pass doctors to create a demand from patients for particular pharmaceutical products, PhRMA's guiding principles include an admonition for manufacturers to dedicate an appropriate amount of time to educating health care providers about their products before beginning advertising. This will allow physicians to speak knowledgably with their patients when asked about the possibility of prescribing a new drug to them. In order to determine what constitutes an “appropriate time amount of time,” companies are advised that they should take into account the relative importance of telling the public the drug is available, health care providers' knowledge about the condition being treated and the complexity of the risk-benefit questions posed by the drug. PhRMA declined to offer more guidance than this to manufacturers because, by doing so, it might delay dissemination of information to the public when no delay was warranted by other concerns such as uninformed medical care providers.

When new information of importance about a drug becomes available, health care practitioners should receive the updated information. If new dangers or concerns are discovered after drug advertisements have begun running, those advertisements should be altered or discontinued, as the situation dictates.

Drug Companies Sign On

Drug companies are asked to submit their proposed advertisements to the FDA for prior approval, something they are not now required by law to do. Currently, drug marketers are supposed to submit their advertisements to the FDA when they first show them, and the agency can comment on them as it sees fit, but there is no prior restraint. If an advertisement that has previously been provided to the FDA is later significantly changed, those changes should also be submitted to the agency.

Television commercials and other forms of DTC advertising should describe alternative means of achieving health goals, where possible. For example, a television commercial could suggest that diet and exercise changes might achieve the same effect as the weight-loss aid it is advertising.

The drugs being advertised should be named along with the condition they are meant to treat. This differs from the FDA's rules, which allow companies to avoid the requirement of listing side effects if their advertisements omit either the name of the drug being promoted or the condition it will treat.

PhRMA's Oversight of the Principles

PhRMA is establishing an Office of Accountability as part of its campaign to self-police the industry's communications to patients. This new office will serve as a comment or complaint center for health care providers and the general public. The Office of Accountability will transmit complaints to the drug manufacturers, receive their responses and publish the results to the public and the FDA. After a year in operation, the Office of Accountability will select an independent panel to review the year's reports to see how the industry performed and to track trends. It will then make recommendations as to any changes that should be made to better promote PhRMA's DTC advertising principles.

Several pharmaceutical companies publicized their acceptance of the new principles soon after the rules were announced. Pfizer Inc. said all its advertisements would be in compliance with the PhRMA guidelines by the end of 2005, if not before. As part of its plan, Pfizer has pledged to allot at least 6 months to physician education before it begins advertising a new product to the public. Pfizer will also discontinue running the type of ads that current FDA rules allow to run without risk information, such as those that state the name of the drug but not the condition it is intended to treat — the “Go ask your doctor about this medicine” TV and print advertisements. Merck & Co. Inc. applauded the new policy that requires submission of advertisements to the FDA for pre-approval, something it has voluntarily done for some time. Even before PhRMA came out with its principles, Bristol-Myers Squibb Co. had instituted a self-imposed 1-year moratorium on DTC advertisements for its new products.