While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians.
GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue, and has questioned the need for looser restrictions. Just before President Donald Trump took office, FDA issued a 63-page memo on public health interests and First Amendment considerations for off-label communications.
Griffith’s bill, meanwhile, would bend the goal posts on what can be discussed between a manufacturer or sponsor and a health care professional.
"The scientific exchange of information about a drug, biological product, or device, as described in paragraph (2), shall not constitute labeling, advertising, or evidence of a new intended use," the bill’s text says.
The bill defines scientific exchange as: The dissemination of scientific findings in scientific or lay media; published scientific studies; letters to the editor; communications at scientific meetings or conferences; medical or scientific publications, reference texts or clinical practice guidelines; communication on a manufacturer or sponsor’s ongoing research and development; and other health economic or outcomes information.
And for unapproved uses or products, such communications must include "a conspicuous and prominent statement that the drug, biological product, or device, or use of such drug, biological product, or device, that is the subject of the communication, has not been approved for marketing," the bill says.
The introduction of Griffith’s bill also comes as Arizona last week became the first state to pass legislation that will allow a pharmaceutical manufacturer or its representative to "engage in truthful promotion of an off-label use of a drug, biological product or device."
Some lawyers, however, have questioned if this new law would have an impact because of current federal requirements.
And even the Goldwater Institute, which has backed so-called "Right to Try" state legislation in an effort to undermine FDA, has said this bill "is a relatively modest reform."