Drugs

Promoting Unapproved Drugs is OPDP Focus: Analysis

Attorney and healthcare communications consultant Mark Senak (FleishmanHillard) says his analysis of CDER Office of Prescription Drug Promotion (OPDP) enforcement actions since 2004 shows that actions regarding promoting an unapproved drug have risen substantially, signaling that this is a current enforcement priority for OPDP. Writing in his Eye on FDA blog, Senak says that half of all enforcement letters ever issued by OPDP involving promotion of an investigational compound have come out since 2016, comprising one-quarter of all the letters issued 2016-2019, or nearly 15% of all violations. And if 2016 is dropped from the mix, he says, the result is even more pronounced, with one-third of the letters being about an investigational compound and comprising nearly one-fourth of all violations.

The post notes that the overall number of enforcement letters issued by OPDP has declined in recent years, perhaps because compliance is up, perhaps in response to a political decision, or perhaps as an expression of available resources. “Rather than ferret out each and every violation it can find, significant or not, FDA is maybe looking to issue letters where it can make a point or make a difference,” Senak says. “Recent enforcement trends, such as they are, bear that out.”

He cautions that while issues involving presentation of risk information are still the most common violation, “clearly promotion of an investigational compound has the focus of the agency just now. So bear in mind, low enforcement does not mean no enforcement.”

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