Industry groups petition the FDA over off-label rule

UPDATE: The FDA announced March 17 that it would delay the rule until March 19, 2018.

Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers’ truthful and non-misleading promotion of its drugs — commonly referred to as off-label promotion — by expanding the evidence the agency can use to assert that a drug has been misbranded.

The FDA filed the final rule in the Federal Register on January 9. A citizen petition was filed by PhRMA, BIO, and the Medical Information Working Group in response on February 8. The rule will go into effect on March 21.

For example, under the new rule — pertaining to the FDA’s definition of intended use — if a manufacturer discovers that one of its products is being used off-label and, as a result, adjusts its supply and scales its manufacturing to meet higher demand for those off-label uses, the FDA could use the company’s internal documents describing that intention to scale up as evidence of a new intended use, industry groups argued in the citizen petition.

An FDA spokesperson said the agency is reviewing the petition.

Intended use is primarily used to determine whether a product is classified as a drug or a consumer product. It is also used to help determine whether the agency can find a drugmaker liable for promoting a drug outside of its FDA-approved intended use, in which case that drug could be considered misbranded.

However, the FDA does not determine a drug’s intended use based on the manufacturer’s definition but rather through its “actual use,” which the agency determines through claims made in labels or advertising materials. In addition, actual use can apply to instances in which a manufacturer has any knowledge of an off-label use of its product, a particularly divisive and rarely enforced provision, according to FDA Law Blog. In fact, the FDA proposed striking the provision in 2015.

Now, the FDA appears to have walked back that proposal in this new notice. The agency expanded the definition of intended use to now include “totality of evidence.” The citizen petition filed by PhRMA, BIO, and the Medical Information Working Group claims that under this new standard “everything may be considered to establish a product’s intended use,” the petitions’ sponsors wrote. They also claimed that the FDA did not give the public sufficient notice to comment on this final rule change, citing the Administrative Procedure Act.

This new definition could prove problematic to drugmakers as off-label use of drugs is not only legal but common.

“This standard would allow FDA to rely even on non-promotional scientific exchange as evidence of intended use,” they 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.”

The FDA held a hearing in November to discuss what a new regulatory framework would look like that would allow truthful and non-misleading promotion of a drug outside of its label. In January, the FDA released draft guidance on how the industry could share information “consistent with the label” but outside of its approved labeling.

At the same time, the FDA released another guidance document to clarify how drugmakers could share healthcare economic information with payers that could lead to more data sharing between the two groups. The FDA is accepting comments on the off-label and payer guidance documents until April 10 and April 19, respectively.