Drugs

FDA/FTC Curbing False Biological/Biosimilar Promos

FDA and FTC are pledging to crack down on anti-competitive practices, such as making false or misleading statements comparing biological reference products and biosimilars, which may be slowing the uptake of biosimilar products. “The agencies intend to take appropriate steps to address companies making false or misleading communications about biologics, including biosimilars and interchangeable products, which will help deter anti-competitive behavior in the biologics market and can help lead to the use of all available biological products,” an FDA notice says.

A joint statement from both agencies notes that FDA has approved twenty-six biosimilars to date, but certain business and intellectual property concerns have delayed the launch of some approved. In 2018, FDA issued its Biosimilars Action Plan that identified one key goal as supporting market competitio n by reducing “gaming” and other attempts to unfairly delay competition. “Strengthening the partnership and interagency coordination between FDA and FTC will help each agency address and deter anticompetitive behavior in the U.S. market for biological products,” the statement says. “Such behavior might include anticompetitive reverse payment agreements, abusive repetitive regulatory filings, or misuse of restricted drug distribution programs.”

For FDA’s part, a draft guidance has been released on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products — Questions and Answers.” It addresses questions companies may have when developing these kinds of materials and provides examples that can help with specific situations biosimilar and reference product companies may experience. FDA notes tha t the document does not discuss considerations unique to promotional materials for interchangeable biosimilars.

Additionally, both agencies are collaborating on a 3/9 public workshop,“FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” It is being billed as bringing together participants from industry, academia and government agencies to discuss issues relating to competition in the biologics market, such as false or misleading statements about biosimilars, and anticompetitive behaviors in the biologic marketplace.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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