Two draft bills that would loosen restrictions on drug and device promotions were considered by the House Energy and Commerce Health Subcommittee July 12.
Rep. Michael C. Burgess (R-Texas), chairman of the subcommittee, said the current 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” and “a lack of relevant information can lead to physicians making patient care decisions with incomplete information.”
Under long-standing policy at the Food and Drug Administration, companies can be subject to criminal prosecution and civil liability if they promote their products for uses the FDA hasn’t specifically approved.
But Reps. Frank Pallone Jr. (D-N.J.) and Gene Green (D-Texas), said they are concerned the draft bills would undermine the current protections against marketing unsafe and ineffective medical products. Pallone is the ranking member of the full House Energy and Commerce Committee and Green is the ranking member of the Health Subcommittee.
The first bill considered by the subcommittee would clarify what information manufacturers can communicate prior to the FDA’s approval of a product. The second bill would enable drug and device manufacturers to proactively discuss certain information outside the scope of FDA-approved labeling.
Burgess said the bills offer “a targeted approach to addressing the problems presented by our outdated regulatory framework for medical product communication.”
Rep. Greg Walden (R-Ore.), chairman of the Energy and Commerce Committee, also expressed support for congressional action to clarify off-label communications. He said the uncertainty in the statute and implementing regulations for off-label communications “does nothing to protect patients” and “it is our job to clarify this statute and get it right.”
Pallone said he is willing to discuss giving manufacturers more clarity on communications, but “broadening communication in the ways proposed under these discussion drafts would undermine FDA’s regulatory review process and the safety and effectiveness approval standard.”
Read my full article on the hearing here.
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