The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.
Bleeding Deaths Linked to Pradaxa
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Doctors prescribe medicine to help keep us healthy. However, a mistake that leads to the wrong medicine being taken can cause serious injury or death. Unfortunately, these types of errors are not uncommon....more
Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more
Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. But, unfortunately, it's a rather fact-specific case with nothing of prurient...more
Watch this news video if you or anyone you know is on a blood thinner. It could provide life saving information. Pradaxa, an anticoagulant medication, helps prevent blood clots and strokes. It’s often used with people who...more
Millions of patients take selective serotonin reuptake inhibitors (SSRIs) for depression, anxiety and other disorders. One out of 10 people in the United States use antidepressants, making them one of the most widely...more
In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more
On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more
For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more
Topamax (topiramate) was first approved by the United States Food and Drug Administration (FDA) in 1996 as an anti-convulsant for the treatment of seizures. Topamax was widely used to treat epilepsy in children and adults....more
On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ...more
This week, the U.S. Food and Drug Administration (FDA) issued a warning that Pfizer’s popular Z-pack antibiotic (also known as Zithromax or Zmax) may cause sudden death in some patients with preexisting heart conditions....more
Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more
Whether by need or by choice, many Americans look for health in a bottle. According to the Centers for Disease Prevention and Control (CDC), in any given month during the three-year period from 2005 to 2008, almost 50...more
In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In...more
Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more
In October, 2010, the U.S. Food and Drug Administration (FDA) approved the drug dabigatran to reduce the risk of blood clots and stroke in patients with atrial fibrillation. Marketed as the twice-daily miracle drug Pradaxa,...more
In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more
As a little kid, I did not have an immediate appreciation that my actions could get me into trouble, and so, without thought, I told the truth. My dad would ask, “Did you write your name on the wall?” I would respond,...more
The State Food and Drug Administration (“SFDA”) issued a Notice on Relevant Issues Concerning Imposing Electronic Barcoding on Imported Drugs (“Notice”) on January 29, 2013 with immediate effect. Pursuant to the Notice,...more
After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more
Atorvastatin is a statin drug prescribed to reduce harmful cholesterol levels and potential incidence of heart disease and stroke. Sold in 90 and 500 tablet bottles, atorvastatin calcium pills manufactured by Ranbaxy, Inc....more
The drug pioglitazone, marketed as Actos®, is prescribed to treat type 2 diabetes. Chemically related to the diabetes drug Avandia, Actos has come under fire in recent years for serious, sometimes fatal side effects....more
With increasing profits to be made in drug development and manufacturing and escalating reliance upon pharmaceutical treatment by the medical community, it seems that new drugs are entering the market every day to treat every...more
The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more
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