FDA Outlines 1st Amendment Issues in Manufacturer Speech
As part of FDA’s reexamination of its rules and policies relating to regulated industry communication on unapproved uses of approved or cleared medical products, the agency has submitted a memorandum to the docket “to provide additional background and seek input on the full range of issues to consider as part of its reexamination, including First Amendment considerations.” The memo notes that at a 11/9-10/16 public hearing, some speakers expressed the view that FDA had not sufficiently discussed the First Amendment in the hearing notice.
“FDA is seeking comment on the public health and safety interests advanced by the FDA authorities, many of which are discussed in this document, as well as comment on what approaches could integrate and advance these sometimes competing public health and safety interests with First Amendment jurisprudence,” it says.
The agency says it believes there is widespread agreement that no government interests are served by firm communications that do not fairly present reliable scientific information. “A firm communication that conveys scientific information that is not truthful, complete, or balanced or that lacks scientific validity has at least the potential to mislead the audience and does not contribute meaningfully to the marketplace of ideas,” it says. “Similarly, firm communications that are designed to cause the audience to reach safety or efficacy conclusions independent of or not supported by the available data are misleading, have the potential to harm patients, and lead to a waste of healthcare resources.”
The memo says the agency’s current implementation approach does not proscribe all firm communications about unapproved uses of approved or cleared medical devices. It notes that FDA has issued guidance documents to describe some of the circumstances when it would not consider a manufacturer’s distribution of reprints, clinical practice guidelines, or reference texts about unapproved uses to be evidence of intended use and/or false or misleading. It also has issued guidance on responding to unsolicited requests for information about FDA-regulated products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.
FDA says it has examined alternative approaches and is concerned that none of them appear to integrate the complex mix of numerous and sometimes competing interests at play and thus do not best advance those multiple interests. It seeks further comment on its review of the alternatives and on other potential alternate approaches.