Drugs

Objections, Support for FDA Drug Regulatory Modernization

Public Citizen says an FDA proposal to use and publicly post, upon approval of an NDA or BLA, an abbreviated integrated review document in place of the more detailed individual medical, chemistry, pharmacology, statistical, clinical pharmacology, biopharmaceutics, and risk assessment and risk mitigation reviews, among others, that have been prepared and regularly posted on the agency Web site for many years “is one of the most dangerous proposals by FDA in years and must not be permitted.” 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 says 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 writes, 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 says 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.”

Taking a contrasting position, Pharmaceutical Research and Manufacturers of America (PhRMA) comments that it “strongly supports a vision of a future new drug regulatory program paradigm that is optimized for early identification and resolution of key issues, promoting efficiencies and effectiveness in drug development, and conducive to highly productive and timely interactions between FDA and sponsors during drug development.

PhRMA says it believes that the new integrated review documents will provide the most meaningful information to stakeholders and encourages the agency to formalize use of integrated review documents to communicate the basis of regulatory approval decisions to the public as a comprehensive and more effective approach to providing clarity on FDA decisions on regulatory approvals. The response also includes specific comments on several issues.

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