Drugs

3rd Circuit Flunks FDA Again Over Illegal Generics

The 3rd Circuit Court of Appeals says a Pennsylvania federal court correctly rejected a Department of Justice request for a conspiracy charge against KVK-Tech, a Newtown, PA, generic drug manufacturer. The lower court had said the government’s indictment failed to state the offense and the government had appealed to the 3rd Circuit.

The company is charged with distributing 383,000 bottles of hydroxyzine between 2011 and 2013 that contained an active ingredient purchased from a Dr. Reddy’s Laboratories facility in Mexico that was not FDA-approved.

In sending the case back to the Pennsylvania federal court for further proceedings on charges that were not dismissed, the appeals court agreed with the lower court’s finding that the indictment charging the company and two executives with conspiracy to defraud and to commit offenses against the U.S. did not state the offense.

The relevant portion of the indictment alleged that the defendants violated provisions of the Federal Food, Drug, and Cosmetic Act that prohibit introducing a “new drug” into interstate commerce unless an FDA approval “is effective with respect to such drug.”

The court said that while the indictment often refers to the hydroxyzine at issue as an “unapproved new drug,” the relevant statutory provisions do not prohibit the introduction of “unapproved new drugs.” Rather, the court said, they prohibit the introduction of any “new drug,” unless an approval of an NDA or ANDA is effective for the drug.

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