Drugs

Data Reporting Case Analyzed

Ropes & Gray says that a recent federal court ruling may require clinical trial sponsors to report a decade’s worth of previously exempted data to ClinicalTrials.gov. “If the government allows the ruling to take effect without appealing, or if it is upheld on appeal, this decision could prove onerous for study sponsors who have relied on this exemption in the National Institutes of Health recommendations,” the firm’s lawyers write. “There is now a substantial amount of data — nearly 10 years’ worth of clinical trial results for products that had not received marketing authorization at the time of trial completion — that may ultimately need to be submitted to ClinicalTrials.gov.”

The analysis gives an overview of relevant clinical trial results disclosure requirements, describes the New York federal court’s rationale for invalidating the government’s interpretation of FDA Amendment Act (FDAAA) provisions in Seife v. Department of Health and Human Services, and discusses implications for industry, academic institutions, and other parties responsible for complying with FDAAA requirements.

Noting that HHS has not announced whether it will appeal the decision, the analysis says that “given the competing priorities at HHS and the historical lack of enforcement related to ClinicalTrials.gov, it remains to be seen whether and how HHS will take any action to require reporting in line with the court’s decision. For now, Responsible Parties should recognize that Basic Results for pre-rule applicable clinical trials of products that were not yet approved or cleared at the time of completion of the trial may need to be reported in the future. In the meantime, it would be prudent for Responsible Parties to take an inventory of clinical trials potentially impacted by the Seife decision so that Basic Results reporting, if ultimately required, could begin without significant delay.”

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