Positions Staked out on Impact of First Amendment on Manufacturer Communication on Off-label Uses

Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Health Law News and Commentary article regarding constitutional concerns surrounding manufacturer communication of information on off-label uses. According to Labson, the FDA should proceed in "a step-wise fashion that balances the benefits to healthcare professionals, payers and other stakeholders receiving a greater range of valid scientific and medical information with the FDA's interest in protecting public health and safety and preserving the integrity of the drug approval process."

Labson adds, "Under the current regulatory system companies have severe legal constraints about how they can communicate about them. In some instances, some other participant in the healthcare system might be talking about it [and] a biopharmaceutical company may feel that they can't respond or engage in the dialogue without worrying about" the regulatory requirements. In other instances, companies "may have unique data and just not be able to share it for fear of violating the rules and in other situations there may be public discourse about an issue, but the company has its hands tied."