Drugs

Medical Groups Want FDA Compounding Discretion

Some 21 medical organizations and professional societies led by the American Medical Association are expressing concern that actions taken by FDA in finalizing compounding-related guidance documents “may significantly hinder our physicians’ ability to provide critical treatments to patients in office settings.” The 8/13 letter says an updated 9/2018 draft guidance on insanitary conditions at compounding facilities “reflected the concerns the physician community raised with the initial draft guidance, and indicated that FDA proposed to exercise enforcement discretion with respect to physician offices preparing sterile drug products for administration to their own patients in office settings.”

The organizations “were pleased to see this shift from the earlier, overly-restrictive proposals that would have undoubtedly limited patient access to critical treatments performed in physician offices,” they write. “However, following a [recent FDA] listening session, we have increasing concern that any final insanitary conditions guidance may once again place onerous restrictions on physician practices, threatening patient access to necessary and timely treatments.”

The letter says that patients of many specialists rely on the ability of their physicians to prepare compounded drugs in-office to avoid certain increased risks, avoid follow-up appointments for treatment, and avoid receiving treatment in higher-cost care settings.

“As FDA works to finalize the draft guidance for insanitary conditions in compounding facilities,” the letter concludes, “we urge you to work closely with the physician community to determine the most appropriate path forward that both ensures sterility of drug products prepared in office settings and maintains access to critical treatments for patients.”

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