FDA Policy/General

OCI ‘Botox Police’ Hit for Low Prosecution Count

Critics say that the FDA Office of Criminal Investigations invests thousands of hours pursuing foreign imported, mislabeled drugs, but too often the cases do not result in prosecution. A lengthy Reuters investigative report finds that prosecutors decline to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent, or strong evidence. Reuters says that its review of more than 170 letters detailing why the Department of Justice declined cases appears to bolster critics’ claims of agency overreaching.

From FY 2008 to 2015, the story says, 53% of OCI cases were closed without action. The news service contrasts this record with 71% of Environmental Protection Agency cases spurring criminal charges and 68% of Internal Revenue Service cases leading to charges. OCI director George Karavestos is quoted as saying that statistics are not a good benchmark to measure OCI success because public health will “always trump the criminal investigation.”

The report says that agency leaders are trying to better align OCI priorities with the Centers that set policy over food, drugs, and tobacco. Current and former FDA managers told the investigative reporters that managers push cases that lack legal merit at the expense of others with more potential that were not pursued, such as steroids, the street-level sale of counterfeit painkillers, and the importation of drugs like Kratom, an opioid alternative. Agents who spoke with Reuters anonymously say they are instructed to focus primarily on cases involving the legitimate supply chain.

Because of a push to investigate use of imported unapproved drugs by doctors such as Allergan’s Botox, some agents said they felt like “Botox police” or the “ATF—Allergan Task Force.” Some said that the crackdown protects drug company prices more than it protects consumers.

In addition to raising questions about investigative focus, the article details how agents have been pulled from investigative work to serve as a security detail for top OCI officials when they are in cities around the country, including traveling in motorcades with blue emergency lights flashing.

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