Drugs

New FDA Head Should Push Trial Transparency: Op-Ed

A Baltimore Sun op-ed column written by two students at the NYU School of Law and a Yale University physician calls on whoever is named as FDA’s new commissioner to commit to enforcing clinical trial transparency. “Doing so is simple, requires no congressional action, and will meaningfully protect patients,” the column says.

The authors review the transparency requirements in the FDA Amendments Act (FDAAA) of 2007 and say that clinical trial transparency allows watchdogs, providers, and the public to confirm that drugs meet FDA’s benchmarks for safety and efficacy, scrutinize data and determine optimal patient treatment, and boost innovation.

“Enforcement of FDAAA was woefully lax during both the Obama and Trump administrations,” the column says. The authors say that while enforcement authority is shared by the National Institutes of Health (NIH) and FDA, the NIH has all but abdicated its enforcement and monitoring power. And FDA had sent only a “few dozen” pre-warning letters in a 2013-2014 pilot program advising sponsors of possible noncompliance. “It’s worth noting that each of the 14 non-compliant sponsors contacted in this pilot program became fully compliant and reported all missing data after receiving FDA’s notice,” the column says. “But left unchecked, hundreds more drug companies, universities, and other trial sponsors have opportunistically reported positive trial results and delayed or withheld others. Today, about a third of applicable clinical trials on ClinicalTrials.gov are missing results.”

The authors note FDA’s authority to fine sponsors who fail to report applicable clinical trial data and say the agency has never issued such fines, which they calculate could have totaled $19 billion since the 2007 enactment of FDAAA. “While zero enforcement may be less expensive for FDA, it costs patients much more in the form of ineffective and possibly dangerous treatments,” the op-ed says. “It also violates Congress’ express enforcement mandate: FDAAA.”

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