After pharmaceutical industry groups filed a petition against the FDA’s new off-label promotion rule, the federal watchdog agency said last week it would delay the rule’s implementation to March 19, 2018. The agency originally intended for the law to go into effect on March 21 this year.
The rule would expand the evidence that the FDA can use to claim that a drug has been misbranded, therefore restricting drugmakers’ off-label promotion of drugs.
The petition, written by the Pharmaceutical Research & Manufacturers of America, the Biotechnology Innovation Organization and the Medical Information Working Group, was filed in early February after the FDA filed the final rule in January.
Defining a product’s intended use helps the FDA determine if a drugmaker is liable for promoting a drug outside of its approved intended use. The regulatory agency defines intended use based on its “actual use”, according to claims made on the label or in advertising materials.
In its new rule, the FDA expanded the definition of intended use to include “totality of evidence”. The citizen petition filed by pharma groups said that under the agency’s new rule, anything and everything could be considered as evidence to establish a product’s intended use.
Off-label use of drugs is legal and common, so expanding the evidence that the FDA can use to claim that a drugmaker misbranded their product could prove problematic to the industry.
Under the new rule, according to the petition, if a manufacturer finds out that one of its drugs is being used off-label and adjusts its supply to compensate for the increased demand, the FDA could use the company’s documents describing the scale-up as evidence of a new intended use.
“This standard would allow FDA to rely even on non-promotional scientific exchange as evidence of intended use,” the group wrote. “If a company engages in scientific exchange about off-label use, forecasts on- and off-label sales, and scales production to meet the combined demand, a prosecutor could decide that this evidence reflects an off-label intended use. The new intended use rule exposes manufacturers to a significant risk of liability for conduct that is entirely lawful and beneficial to the public health.”