Two new bills, that would allow drug and device manufacturers to provide more information about their pre-approval and post-approval products, are currently being considered by the House Energy and Commerce Health Subcommittee.
The first bill aims to clarify what product information companies can share with medical professionals and healthcare decision makers prior to receiving FDA approval for their products. The second bill would allow companies to proactively engage in discussions regarding off-label usage of their approved products, i.e. uses that are fall outside of the scope of the FDA-approved labeling.
If passed, these bills could potentially create more transparency and enable manufacturers to be more open about the current scientific information available. Proponents of these bills argue that this would allow healthcare professionals to become more informed about the benefits and risks of available drugs which would help them make better and safer decisions regarding their patients’ use of medications.
According to Rep. Michael C. Burgess, who is the chairman of the subcommittee, “We owe it to the patient and medical communities to ensure that there is free and full dissemination of truthful and nonmisleading scientific and medical information to health-care professionals,”
However, many Democratic lawmakers are worried that these bills could undermine the current protections in place that limit the marketing of potentially unsafe and ineffective medications and the uses of them.
These concerns are also shared by many consumer groups. The director of Public Citizen’s Health Research Group, Michael Carome, for example, has claimed that “These bills would threaten patient health and safety by undermining the current regulatory regimes for ensuring that drugs and medical devices are safe and effective for each intended use,” Carome said.
It is yet to be seen what verdict the House Energy and Commerce Health Subcommittee will reach regarding these two new bills. However, it is clear that industry opinion remains split on this issue for the time being.