FDA fails to withdraw unproven blood pressure drug that has been on the market for 18 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients

Public release date: 16-Aug-2010 – HRR: UPDATE As of 15 FEB 2014 ProAmatine or generic versions are still on the market being prescribed – According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data – company has never conducted a mandatory follow-up study to…

Study examines expedited FDA drug approvals, safety questions remain / Avg. Drug is tested on only 104 patients prior to approval

Contact: Renee Brehio rbrehio@ismp.org 704-831-8822 The JAMA Network Journals Fewer patients were studied as part of expedited reviews of new drugs approved by the U.S. Food and Drug Administration (FDA) in 2008 and some safety questions remain unanswered, according to a study published by JAMA Internal Medicine, a JAMA Network publication. The FDA is authorized…

Ew! Injectable antibiotic ( VOLUNTARY ) recall prompted by floating bits of hair, cotton and metal inside drug vials

The FDA  announced a recall of cefepime, an intravenous drug used for pneumonia, urinary  tract, skin, and abdominal infections The visible  particles in the drug, which was distributed nationwide, can cause blood clots,  strokes, and heart attacks, among other catastrophic  issue By  Daily Mail Reporter PUBLISHED: 08:14 EST, 16  October 2013 |  UPDATED: 10:04 EST,…

Drugs now to be approved based on a educated guess that it will help the patient, not necessarily improved survival

U.S. drugmakers cheer ‘speed lane’ for breakthrough therapies Source: Reuters – Wed, 24 Jul 2013 11:53 PM Author: Reuters By Toni Clarke WASHINGTON, July 24 (Reuters) – A new regulatory pathway could shave years off the traditional drug approval process in the United States, according to some companies whose drugs have been given “breakthrough therapy”…

International Counterfeit Drug Ring Hit in Massive Sting / 1,677 illegal pharmacy Web Sites claiming to be CVS, Walgreens etc..

Pill of Goods: International Counterfeit Drug Ring Hit in Massive Sting Court documents review process that led the FDA to shut down more than 1,600 illegal pharmacy Web sites By Dina Fine Maron  | Wednesday, July 3, 2013 | 5 Pill of Goods Image: EssjayNZ It may be the largest organized crime network that you have…

FDA – 2012 law now in effect which lifts conflict of interest restrictions on FDA advisory panels

Contact: Kathy Fackelmann kfackelmann@gwu.edu 202-994-8354 George Washington University School of Public Health and Health Services Conflict-of-interest restrictions needed to ensure strong FDA review Panel members with ties to industry might lead to approval of unsafe drugs, new analysis suggests WASHINGTON, DC—A 2012 law that loosened conflict-of-interest restrictions for FDA advisory panels could weaken the agency’s…

FDA redactions policy violates Freedom of Information Act / Conceals Drug and Medical device dangers form the public

Open gov’t groups: FDA redactions rules skirt law Transparency groups: Long-standing FDA redactions policy violates Freedom of Information Act By Matthew Perrone, AP Health Writer | Associated Press – 22 hrs ago   WASHINGTON (AP) — A federal policy that allows the Food and Drug Administration to withhold key details about drugs, medical implants and other products…