The Food and Drug Administration (FDA) has delayed a rule that would regulate off-label drug and device promotion. The rule was scheduled to take effect March 21, 2017, but has been delayed until March 19, 2018, so the FDA could consider public comments. The rule is viewed as giving the FDA broad authority to police off-label promotion, and the delay comes in response to a petition to stay and for reconsideration filed by Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drugmaker coalition called the Medical Information Working Group.
The FDA contends that misleading information could do more harm than good, and that looser restrictions would make manufacturers less inclined to do perform due diligence by conducting scientifically sound clinical studies. Industry argues that the rule will impede dissemination of information, thus violating their First Amendment rights, and will “chill innovation.” They also contend that the FDA violated the Administrative Procedure Act (APA) by not providing adequate notice and an opportunity to comment on the revised “intended use” definition as published.
Doctors can prescribe drugs off-label, or for uses outside those indicated on their label as approved by the FDA. However, under the False Claims Act and the FDA, drug manufacturers cannot advertise or promote their products off-label. Opponents of off-label promotion argue that the off-label use has not passed scrutiny by the FDA, the chief regulatory body charged with ensuring the safety and efficacy of a drug for specific indications, and exposes patients to inappropriate risk. In recent years, however, there has been a trend toward heightened protection of commercial speech in the health care arena, and opportunities have opened up for off-label promotion.
In the 2002 Supreme Court case Thompson v. Western States Medical Center, the Court extended First Amendment commercial-speech protection to compounding pharmacies for the first time, allowing them to promote their compounded drug products. In 2012, the Second Circuit Court of Appeals further expanded First Amendment commercial speech protection in pharmaceutical marketing in United States v. Caronia. The Court found that the First Amendment protected the right of a pharmaceutical sales representative to promote off-label use to doctors in a way that was not untruthful or misleading.
Currently, the “intended use” definition states that if a manufacturer has mere knowledge that a drug or device is used for off-label conditions, purposes or uses, the manufacturer is required to provide adequate labeling for that use. (See 21 CFR §201.128 and 21 CFR §801.4). The proposed rule issued on Sept. 25, 2015, would have deleted this standard. However, the final rule, as published in January, retained and amended the current language to include a “totality of the evidence” standard that was not in the proposed rule.
The new standard would allow the FDA to consider all evidence, including internal deliberations, clinical practice guidelines and non-promotional scientific exchange as evidence of intended use to determine whether a company engaged in off-label promotional activity. The FDA would continue to determine the product’s intended use by its labeling, promotional claims, advertising, oral or written statements by a manufacturer or its representatives, circumstances surrounding the distribution or sale of a product, and other relevant evidence.
In its notice to delay, the FDA stated that “good cause” existed for the delay because it would allow the public to comment on the language that was introduced in the final rule that did not first appear in a proposed rule, thereby skirting the Administrative Procedure Act. Public comments on the rule must be submitted to the FDA prior to May 19, 2017.
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