Drugs

Nevada Man Pleads Guilty to Importing and Selling Misbranded Drugs

A Nevada businessman has pleaded guilty to importing and distributing misbranded prescription erectile dysfunction drugs from India, generating more than $1.9 million in online and retail sales, federal prosecutors say. The case was investigated by FDA's Office of Criminal Investigations and the U.S. Postal Inspection Service.

David Ralph Webber of Henderson, NV, admitted in federal court that he smuggled prescription drugs containing sildenafil and tadalafil — the active ingredients in Viagra and Cialis — into the U.S. and sold them through businesses he owned, Passion Plus Enterprises Inc. and Whole Science Health.

According to the U.S. Attorney's Office for the District of Nevada, Webber was not registered with FDA as a pharmaceutical manufacturer and was not licensed to distribute prescription drugs. Prosecutors indicate that from at least 2018 through the present, Webber imported hundreds of thousands of capsules and tablets manufactured at unregistered facilities in India. To avoid customs scrutiny, he falsely described wire transfers to overseas manufacturers as payments for business management consulting services.

Webber pleaded guilty to one count of introducing a misbranded drug into interstate commerce and one count of mail fraud. He is scheduled to be sentenced on 10/19.

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