Drugs

Hear Danco Mifeprex SCOTUS Appeal: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says the Supreme Court should hear an appeal filed by Danco Laboratories and FDA challenging a 5th Circuit Court of Appeals decision that would restrict how the abortifacient Mifeprex (mifepristone) is distributed to and used by patients. In its petition, Danco asked the high court to determine whether courts “can disregard constitutional and statutory limits on judicial review of executive action in order to overrule an agency decision they dislike.”

Danco said the court should take the case because it is a “case of indisputable importance. For the women and teenage girls, healthcare providers, and states that depend on FDA’s actions to ensure safe and effective reproductive healthcare is available, this case matters tremendously. And for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of data will have a wildly destabilizing effect.”

In its amicus brief, PhRMA says that if the 5th Circuit decision is not reversed, the court’s reasoning “could invite boundless litigation to FDA drug approvals…. Should the decision below stand, FDA’s safety determinations will risk becoming mere precursors to litigation, rather than durable decisions that protect a company’s massive investment in the product’s lengthy research and development process.”

PhRMA concludes that the appeals court’s ruling is deeply flawed and would jeopardize the settled regulatory framework on which the biopharmaceutical industry, and the patients it serves, relies. “Permitting courts to second-guess FDA’s congressionally delegated science-based safety judgments could destabilize the pharmaceutical and biotechnology industry, incentivize litigation by third parties, and discourage innovation in drug development, all to the ultimate detriment of patients,” PhRMA warns.

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