WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining ways Congress could clarify how drug and device companies can responsibly disseminate truthful and non-misleading data and information that is not included in their product labeling.
Following a series of recent court decisions, FDA’s ability to restrict such communication in a manner that does not run afoul of First Amendment protections has been very limited. #SubHealth also discussed the need for manufacturers to share clinical and economic information about their medical products with entities that make coverage decisions prior to FDA approval.
“Our legal framework for the regulation of manufacturer communication prevents health care professionals from receiving the most current scientific information available about the benefits and risks of FDA-approved medicines,” stated Chairman Burgess. “A lack of relevant information can lead to physicians making patient care decisions with incomplete information. This is both unfair to the physician and unsafe for the patient.”
Further explaining the two bills before #SubHealth, full committee Chairman Greg Walden (R-OR) said, “These bills do not provide manufacturers with free rein to communicate any and all information about their products. They establish targeted statutory boundaries within which manufacturers may responsibly disseminate accurate, and up-to-date information about medical products. These clarifications will lead to a better-informed health care system and will ensure that patients receive high-quality care based on current, sound scientific and clinical information.”
Dr. George F. Van Hare, Co-Director of St. Louis Children’s and Washington University Heart Center, testified, “The current regulatory approach limits the ability of a manufacturer to share data not referenced in the package insert. This means that much valuable information may never be conveyed to clinicians and other medical decision-makers. Essentially, we do not get the benefit from data that has not been derived from randomized, controlled clinical trials. Sharing comprehensive, scientifically valid data is critical to the practice of medicine generally, and it is even more critical for particular specialties.”
Ms. Coleen Klasmeier, Partner, Sidley Austin LLP, reiterated these concerns and said that legislation could be helpful, testifying that, “FDA action has been slow and ineffectual. It has been almost six years, for example, since FDA published a notice in the Federal Register soliciting public comment on the scope of the scientific exchange safe harbor and on a new draft guidance on unsolicited requests. Where FDA has taken action, the policy has tacked in the wrong direction, becoming less clear and more speech restrictive.”
Ms. Kat Wolf Khachatourian, Vice President, Delegation Oversight, Pharmacy Services & Strategy, Qualchoice Health Plan Services, highlighted draft guidance from FDA earlier this year, which was non-binding and lacked certainty regarding the Pharmaceutical Information Exchange (PIE). Ms. Khachatourian stated, “Therefore, there is a need for Congress to engage in this topic to create a legislative safe harbor for PIE so that it is clear that the proactive dissemination of certain information does not violate the prohibitions against preapproval promotion and does not run afoul of the labeling, misbranding, and intended use provisions of the Federal Food, Drug, and Cosmetic Act and its impending regulations. H.R. 2026, the PIE Act incorporates the consensus recommendations developed by the multi-stakeholder group, creates a very narrow safe harbor for a very specific purpose, and will improve patient access to emerging medication therapies.”
Ms. Linda House, President of the Cancer Support Community (CSC) gave the patient perspective on product labels, saying, “It is widely observed that the performance of a drug may be different once it is introduced into general use, which will likely be a broader, less-controlled population. CSC appreciates the work of the FDA and sponsors of phase IV studies, but also recognizes that these studies do not capture comprehensive data for the use of a product in the real world. Also, it is a rare occurrence for the label to be updated in a manner that would allow for proactive communication about findings.”
For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.