Drugs

Public Citizen Sues FDA Over Balversa Review Docs

Public Citizen has filed suit against FDA in DC federal court to obtain the scientific reviews used 4/2019 to grant accelerated approval for Janssen Pharmaceutical’s Balversa (erdafitinib), a treatment for certain adult patients with locally advanced or metastatic bladder cancer (see approval story). The group filed a Freedom of Information Act (FOIA) request for the supporting reviews after realizing that such reviews are no longer being routinely released as part of the agencyֺ’s review action actions posted on its Web site.

In its suit, Public Citizen complained that FDA had moved its FOIA request to the “complex queue and that the average wait time for FOIA requests in the complex queue is 18–24 months.” The group asked the court to declare that FDA’s withholding of the requested records is unlawful and order it to make the requested records available without delay.

Moreover, Public Citizen has publicly expressed dissatisfaction with FDA’s decision to stop posting the scientific reviews in favor of a consolidated and collaborative review document. In comments to an agency docket on improving approval package documentation and communication as part of modernization of the new drugs regulatory program, the advocacy group said the “ill-conceived proposal would, at the least, be a major step backwards in agency transparency with respect to the data that the agency relies on when approving new drugs or biologics and the agency’s assessment of these data.”

Beyond the issue of review transparency, Public Citizen wrote, it is unclear from the agency proposal whether individual reviewers in each discipline would even continue to write separate review documents, as currently occurs. The letter said that eliminating production of review documents by the individual disciplines “could lead to dangerous groupthink and inhibit the expression of important minority views, further undermining FDA’s review and approval process for drugs and biologics and threatening public health.”

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