Drugs

Postmarketing Oversight Still Challenges FDA: OIG

The HHS Inspector General says that FDA is issuing more postmarketing study requirements (PMRs) to drug sponsors but continues to have problems with its data management system and work processes, which hinder its ability to track those requirements. The report says that in 2006 the Inspector General found that the agency could not readily identify whether or how timely postmarketing studies were progressing toward completion, and that it lacked an effective monitoring system for the studies.

Since then, it says, the FDA Amendments Act (FDAAA) has expanded the agency’s authority to require postmarketing studies and to take enforcement action when sponsors are out of compliance.

A review of agency postmarketing requirements from FY 2008-FY 2014 found that FDA used its FDAAA authority to issue half of all requirements in the study years, and required multiple types of studies and clinical trials to fulfill requirements. It issued PMRs for both sNDAs and NDAs, with the majority related to NDAs. FDA issued more PMRs for NDAs reviewed through expedited programs then for non-expedited NDAs. Sponsors are completing most PMRs on schedule, the review found, although a few are delayed.

The Inspector General recommended that FDA:

provide a standardized form for PMR annual status reports, ensure that they are complete, and require sponsors to submit them electronically;
build capacity in the Document Archiving, Reporting, and Regulatory Tracking System to support PMR oversight; and
determine the reasons why some PMRs have been delayed for years, and act as appropriate.

The report says that the agency implemented the third recommendation and concurred with the first two.

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