Drugs

Comments on FDA REMS Summary Posting Proposal

Pharmaceutical Research and Manufacturers of America (PhRMA) says that if FDA continues with a plan to post on a Web site a high-level summary of the agency’s review of REMS (risk evaluation and mitigation strategy) assessments, it should consider inviting applicants to review the summaries and discuss with FDA any conclusions that an applicant is not meeting its goals before the publication of the summary. The PhRMA letter also identifies alternative approaches it asks the agency to consider when deciding whether and how to implement the summary approach.

The American Pharmacists Association says it believes making the summaries available will serve healthcare providers and patients by providing transparency and guidance for future REMS program improvements and assessments. The association provides some suggestions for the agency to consider.

AstraZeneca comments that the proposed summary “key findings” topic is a risk because it could cause misunderstanding since members of the public are not experts in the measures and complexities that would be included in the report. It cautions that there could be a negative impact on public trust and confidence.

Finally, Alkermes suggests that the summary as proposed is likely to have limited utility to the broad stakeholder audiences the agency intends to benefit. It recommends that FDA consider the different audiences that might use the summaries and tailor communications to each audience.

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