Feb. 18, 2016 – A bill introduced in the House last week by Rep. Rosa DeLauro (D-Conn.) — the Responsibility in Drug Advertising Act of 2016 (H.R. 4565) – would prohibit direct-to-consumer (DTC) advertising for the first three years following a drug’s approval and allow the Department of Health and Human Services (HHS) to waive the prohibition in the third year only if a drug company submits an application to HHS and the agency finds that DTC advertising of the drug “would have an affirmative value to public health.”
Even after the third year, this bill, introduced Feb. 12, would authorize HHS to continue prohibiting DTC advertising for a product if the Secretary “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.” (BILLS-114hr4565ih)
“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,” said Coalition for Healthcare Communication Executive Director John Kamp. “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,” Kamp said, noting that at present her bill has no co-sponsors and has been referred to the Committee on Energy and Commerce.
If enacted, the bill would likely be declared a violation of the First Amendment, according to Kamp. “Indeed, it is largely unnecessary because, since 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on DTC advertising, provision 6, more appropriately addresses the possible delay of DTC after a drug is approved,” he explained.
Specifically, PhRMA Code on DTC Advertising, provision 6, states:
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.
“The PhRMA Code recognizes that while sometimes it may be appropriate to delay DTC, in other circumstances speedy DTC best comports to the public interest. In such matters, flexible, self-regulatory standards are much better than rigid, politically-inspired, measures,” Kamp said.