Life Science Compliance Update

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February 24, 2016

Responsibility in Drug Advertising Act of 2016 - Introduced to Restrict DTC - Direct to Consumer Advertising

United States House of Representatives member Rosa DeLauro introduced a bill the Responsibility in Drug Advertising Act to the House of Representatives that would restrict most direct to consumer (DTC) advertising of a new drug for the three years following the drug's approval. The only way around the three-year long DTC ban is if the Department of Health and Human Services (HHS) waived the waiting period. Such a waiver would come only after the drug sponsor submits an application requesting such to HHS and HHS determined that DTC advertising of the drug would "have an affirmative value to public health."

The legislation doesn't stop there, however. It takes it a step further, not only banning DTC advertisement for the first three years of a drugs life, but also granting HHS continued authority to prohibit DTC advertising of certain drugs after that three year period. HHS can invoke that authority if it determines that the drug has "significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, the scientific literature, any clinical or observational studies, or any other appropriate resource." This authority continues on forever.

Not surprisingly, the bill has no cosponsors. It is possible that if this bill does become law (which is not very likely given the contentious election year and the extreme pressure it places on the First Amendment), it would actually be deemed unconstitutional and a violation of the First Amendment. According to Bob Ehrlich, CEO of DTC Perspectives, he believes that this bill is meant to "permanently kill DTC since the adverse event standard is so vague the Secretary [of HHS] can point to them as an excuse to continue bans after three years."

Not only is the bill a seemingly absurd personal vendetta against the pharmaceutical industry, but it is also an unnecessary reach into the advertising world of pharmaceutical companies. The PhRMA Code itself actually has a provision on DTC advertising, which recognizes that it may occasionally be appropriate to delay DTC, and in other circumstances it may be best to speed DTC up. Having a federal regulation gets in the way of such a self-governing process, and has the potential to seriously tangle up DTC efforts, which can have a direct impact on patient care and health.

The relevant PhRMA Code provision, provision six, reads as follows:

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 and to alert them to the upcoming advertising campaign 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 are encouraged to consider individually setting specific periods of time, with or without exceptions, to educate health care professionals before launching a branded DTC television or print advertising campaign. Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources.

Coalition for Healthcare Communication Executive Director John Kamp stated, "while Rosa DeLauro has never been a friend of the pharmaceutical industry or a leading thinker on medical marketing issues, she is a high ranking minority member of the House Appropriations Committee, including the subcommittee with jurisdiction over the FDA. The Coalition takes her bill very seriously and will be working hard with the 4As and other allies to ensure that it does not advance on the House agenda." The bill was referred to the House Committee on Energy and Commerce the same day it was introduced.

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