Drugs

FDA ‘Off-Label’ Enforcement Increasing: Attorney

In recent years, FDA has demonstrated increased interest in regulating “off-label” communications, according to attorney Chia-Feng Lu (Greenberg Traurig). Writing in an online National Law Review post, Lu sees greater risk for medical product firms coming from uncertainty over a recent FDA guidance on communication of scientific information on unapproved uses (SIUU) and more aggressive enforcement by the CDER Office of Prescription Drug Promotion. Also, he says, constitutional challenges to FDA regulation of speech may become more difficult following a 1st Circuit Court of Appeals affirmation of the 2016 conviction of former company executives on misdemeanor adulteration and misbranding charges for their involvement in the off-label promotion of a purported steroid delivery device when the device was only cleared as a saline-eluting sinus spacer.

“In the coming months,” Lu concludes, “firms should anticipate FDA’s publication of final SIUU communications guidance and increased enforcement of that guidance alongside growing enforcement of the ‘consistent with FDA-required labeling’ guidance. Firms should also monitor judicial developments, including the 1st Circuit’s ruling that is likely to be appealed to the Supreme Court. In the meantime, however, firms should carefully review their compliance programs and communications using the current guidance versions and determine their appetite for risk.”

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

Read more

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