Drugs

FDA ‘Transitional Biologics’ Position ‘Ripe for Litigation’: Attorneys

Attorney Scott Lassman (Goodman) says FDA’s position on transitional biologics, which is approaching a 3/23/20 effective date, is “ripe for litigation.” Appearing with two colleagues on a webinar on biosimilar litigation, Lassman defined transitional biologics as protein products that for historical reasons have been reviewed by regulators and approved as drug products, i.e., insulin. Before the Biologics Price Competition and Innovation Act (BPCIA) revised the definition, he said, many proteins were regulated and approved as drugs.

According to the BPCIA, Lassman said, NDAs, 505(b)(2) applications, and ANDAs are allowed to be permitted for most proteins until 3/23/20. From that date on, approved NDAs, 505(b)(2)s, and ANDAs will be deemed to be BLAs. According to an FDA 3/14/16 draft guidance, the agency will not approve a pending NDA, 505(b)(2), or ANDA for a protein product after the 3/23/20 deadline, and sponsors will need to refile the applications as BLAs.

Lassman said that position creates a regulatory dead zone of several years as what he calls “reasonable applicants” decide not to submit any of the three application types for months or years before 3/23/20 because of the risk that they may not be approved by then and would have to be refiled as BLAs. The attorney said he believes the draft guidance is “arguably inconsistent” with the law.

“Congress allows submissions until 3/23/20, so there is no statutory basis to deny approval,” he concluded. “But FDA is saying they won’t review the submission. I don’t believe that was the congressional intent.”

Other Goodman attorneys discussed recent BPCIA litigation and issues involving the Patent Trial and Appeal Board.

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