FDA Seeks Input as it Reviews Off-Label Communication Rules

The FDA wants advice from manufacturers and the public on off-label communications, one of the agency’s top priorities for 2016.

The FDA wants to know whether information from manufacturers is more informative than other off-label information, and what kind of limitations it should set. For example, it would like feedback on whether companies should be able to communicate directly with patients and consumers about unapproved uses and whether they should be required to provide disclosures in those cases.

The agency also needs advice on how it should monitor off-label communications and what the consequences should be for communications that are false, misleading or would raise public health issues.

Decision-making Factors

As off-label information becomes more widely available from multiple sources, the FDA would like input on how it affects manufacturers’ likelihood of providing their own off-label communications. It also wants to learn about other factors, like financial considerations, that might affect companies’ decisions to provide off-label communications.

The public notice poses a variety of other questions, such as how the FDA can assess the impact of increased off-label communications on prescribing behavior, product development and research on new uses. It notes these communications might change the incentives for healthcare players to conduct various activities — such as trials.

For example, the agency asks if increased off-label communications could affect companies’ “incentives to generate robust data” on new uses and to apply for marketing authorization for those uses. It also considers whether an increase could affect people’s willingness to participate in trials.

Additional questions address:

• What standards should apply to off-label communications;
• Whether companies must provide additional information if the off-label communication is based on data that are not publicly available; and
• How increased payer and formulary influence on prescribing might spur companies to generate data on new uses.

As medical providers continue to consolidate, insurance carriers are more likely to restrict coverage based on value assessments and performance measures, the FDA notes. Therefore, it seeks advice on whether these changes might prompt companies to provide more data on off-label uses and how it might change their likelihood of submitting that data for marketing authorization.

Changing Legal Landscape

Recent legal cases related to off-label promotion — one involving Amarin and one involving Vascular Solutions — have changed the landscape regarding off-label promotion and put pressure on the FDA to issue guidance on off-label speech for all medical products.

Under the Amarin ruling, the agency is bound by the terms of an August 2015 injunction permitting Amarin to promote cholesterol drug Vascepa off-label using court-approved language to ensure that the information is truthful and not misleading (IDDM, March 11).

In the Vascular Solutions case, the company and its CEO were acquitted of charges involving “off-label” promotion of its Vari-Lase Short Kit in a federal court in Texas (IDDM, March 4).

The FDA will take comments on off-label communications during a two-day public hearing Nov. 9 and 10 and will accept written comments on the public notice until Jan. 9, 2017. The notice is available at www.fdanews.com/09-01-16-offlabel.pdf. — April Hollis