Drugs

Man Pleads Not Guilty to Counterfeit Drug Charges

The Justice Department says that Junaid Qadir, 33, of Karachi, Pakistan, entered a pro-forma not guilty plea in Colorado federal court to multiple charges of illegal importation and sale of misbranded and unapproved new drugs, some of which were alleged to have been counterfeit or controlled substances, and all of which were manufactured overseas and shipped to the U.S. An agency news release says that Qadir acted with his brother and other unknown individuals to advertise on Internet Web sites and through business-to-business Internet Web site platforms their firm, JNS Impex, to solicit orders for a variety of brand name and generic prescription drugs, mostly in commercial and wholesale quantities.

The government alleges that Qadir and the others would fill the drug orders for U.S. businesses and individuals by procuring brand name and generic drugs that they knew to be unapproved by FDA for the U.S. market from suppliers whose drug manufacturing facilities were not approved by FDA and whose packaging and patient literature for the drug also were not approved by the agency.

The release says that Qadir would often cause the drugs being shipped to the U.S. to evade detection by customs authorities by having them concealed, in loose format, in plastic vitamin bottles and water bottles. They also had the shipments accompanied by customs declarations that inaccurately or misleadingly described the contents of the shipments or without customs declarations altogether. The drugs would often be shipped in mail parcels without packaging, without labels, and without patient safety leaflets or other written instructions and information, the government says.

The Justice Department says that the drugs included counterfeit or unapproved versions of Viagra, lorazepam (Ativan), alprazolam (Xanax), diazepam (Valium), zolpidem (Ambien), and phentermine.

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