Drugs

FTC Joining FDA in Data Integrity Focus

The Federal Trade Commission (FTC) is signaling an interest in the integrity of data cited by companies to support marketing claims. Attorneys Raqiyyah Pippins and Neha Patel (Arnold & Porter) write in an online post that in a letter defending its finalized consent order with Carrot Neurotechnology, FDA said that the peer-review process may not always catch the “misreporting of underlying data” and “improper data analysis” that is noticed by the agency during its review of claim substantiation. “When coupled with FDA’s focus on data integrity issues, the FTC’s statements in the letter suggest that companies may want to more closely scrutinize the data underlying even published, peer-reviewed study reports before relying on the reports as support for health-related product claims,” the attorneys write.

The post says that FTC may take it upon itself to double-check the accuracy of data and analysis reflected in a published peer-reviewed study offered in support of a claim. And if a discrepancy is discovered, they say, FTC may attempt to hold the company responsible for claims made in reliance on the inaccurate study report, especially if the study was conducted, controlled, or sponsored in part by the company or its agent.

“The FTC’s interest in the accuracy of the underlying data and analysis reflected in study reports is in alignment with FDA’s focus on similar data integrity issues,” the post concludes. “Over the past few years, FDA has issued a series of Warning Letters regarding alleged data integrity issues reflected in study reports that FDA has uncovered during facility inspections. When reviewed in context, the FTC’s focus on data integrity may reflect a convergence between what FDA and FTC consider to be sufficient quality control measures for the data and analysis underlying study reports. With this in mind, companies may want to take advantage of the opportunity afforded by the agencies’ publicized enforcement activity related to data integrity concerns to review (and strengthen) internal protocols for evaluating studies before they are relied upon to support health benefit-claims for consumer products.”

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