Drugs

California Bill Says Pay-for-Delay is Anticompetitive

Legislation awaiting signature by California’s governor does not prohibit pay-for-delay settlements between branded and generic drug companies but presumes an anticompetitive effect if, as part of a Paragraph 4 litigation settlement, an ANDA sponsor receives anything of value in exchange for limiting or foregoing entry of a generic drug product. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that “anything of value” includes an exclusive license or promise that the branded company will not launch an authorized generic version of the reference-listed-drug. However, she writes, it is not specifically defined, leaving room for interpretation.

Parties to a Paragraph 4 settlement can overcome the anticompetitive presumption if they can demonstrate that the value received by the ANDA sponsor is fair and reasonable compensation solely for other goods or services or that the agreement has directly generated procompetitive benefits that outweigh the anticompetitive effects of the agreement. She says this effectively shifts the burden from the government to demonstrate that a settlement is anticompetitive to the parties to show that it is not anticompetitive, making it significantly easier for the government to challenge such agreements.

Koblitz notes that the legislation is like a bill introduced in Congress in 2017 and again in 2019 but has not gone anywhere. “Given the lack of traction on a federal stage, California appears to have taken a page from the drug pricing control efforts to try to regulate at the state level,” she concludes. “However, this increasingly common tactic is bait for constitutional challenges, so it wouldn’t be surprising if California AB 824 is challenged, especially since industry is not in favor of this type of legislation.”

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