Drugs

Stakeholder Comments on Biologics Advertising Q&A

Janssen says it supports policies for biologics and biosimilars that are guided by patient safety and clinical considerations and are consistent with the protection of intellectual property. In a comment on an FDA draft guidance with questions and answers on promotional labeling and advertising considerations for prescription biological reference and biosimilar products, the company makes points related to the scope of the draft guidance, the disclosure of interchangeability status, and the application of the “net impression” test.

Pfizer’s comment letter says it is important to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway. It encourages FDA to also address interchangeable biosimilar labeling and promotional materials to help ensure that they avoid representing or suggesting that a biosimilar product is less safe or effective because it has not been designated as interchangeable.

The Better Business Bureau National Advertising Division says it can serve as a model of self-regulation for FDA as the agency evaluates advertising considerations for biological reference and biosimilar products and especially looks at how fair competition and consumers are harmed by false or misleading promotional communications about medical products.

Finally, Pharmaceutical Research and Manufacturers of America (PhRMA) makes these points in its letter:

FDA regulation of advertising and promotional labeling must be consistent with First Amendment principles;
PhRMA supports an FDA recommendation to identify accurately whether the data or information referenced in promotional materials pertains to the reference product, the biosimilar product, both products, or a non-U.S.-licensed competitor biological product; and
the final guidance should recommend that promotional materials for an interchangeable biological product reflect accurately the statutory meaning of an Interchangeability determination.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome