“Female Viagra” Drug, Flibanserin Approved by FDA on Third Attempt

Unlike its counterpart medications for male erectile dysfunction like Viagra or Cialis, Addyi will not be taken on an “as needed” basis. Citing differences in sexual function between men and women, clinical sex therapist Judy Kuriansky said, “Women’s sexuality is very complicated. It’s not a matter of just taking that pill, by the way, and then all of a sudden the lights go on.” Kuriansky added, “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. It’s complex.


Duodenoscope Sterilization a Focus as FDA Warns Three Device Makers

The regulator sent the letters to the Olympus, Fujifilm, and Pentax as part of an effort to fight against a wave of deadly bacterial infections attributed to the insufficient cleaning and sterilization of the devices. Duodenoscopes are reusable flexible tubes that go down the throat in order to treat gastrointestinal tract ailments.


Three More Birth-Defect Lawsuits add to GSK’s Zofran Tally as MDL Deadline Approaches

The lawsuits accuse GSK of “off-label” marketing, that is, it is prescribed for ailments (pregnancy) that is not mentioned in the drug’s official FDA labeling. Zofran’s 1991 FDA approval was for “treatment of nausea and vomiting related to chemotherapy and surgery.” According to San Francisco attorney Rachel Abrams, speaking at a bar conference in the city regarding the lawsuits, “If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”


FDA Warns Drugmaker Duchesnay over Kim Kardashian Instagram Post

Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters.


FDA Approves Nestle’s Maggi Noodles, Banned in India

Foodmaker Nestle scored a major victory late Monday night when the U.S. Food and Drug Administration (FDA) granted marketing approval for the company’s Maggi noodles within the U.S. The U.S. joins six other countries in allowing the sale of the two-minute instant snack noodles, which had been tested by the regulator for unsafe levels of


Medtronic Issues Recall for Newly-Approved Heart Device

Leading medical device manufacturer Medtronic has issued its second recall in as many weeks involving recently developed technology. Coming off of the European recall of its MiniMed 640 insulin pump last week, which is scheduled for a Pre-Market Approval (PMA) review in the U.S. later this year, the company has recalled nearly 7,000 EnVeo R


DOJ Subpoenas Allergan as Generics Antitrust Probe Widens

In the wake of a buying and selling frenzy, Irish drugmaker Allergan has been subpoenaed by the Department of Justice (DOJ) over antitrust concerns regarding the pricing of its generic drugs. Last week, the company announced a $40.5 billion selloff of its generics unit to the global generic market leader, Israeli-based Teva Pharmaceuticals. That deal



In Memoriam: Labor Health Crusader Dr. Donald L. Rasmussen

The New York Times paid tribute yesterday to a man whose death nearly went unnoticed in a national sense, but whose life needs to be celebrated. Dr. Donald L. Rasmussen died on July 23rd in Beckley, West Virginia at the age of 87. According to his stepdaughter, Julia Holliday, Dr. Rasmussen died from complications following


Medicare Turns 50 as the NOTICE Act awaits President Obama’s Signature

7/31/2015 The U.S.’s fundamental national healthcare program Medicare, as well as Medicaid officially turned 50 years-old on Thursday. President Lyndon Johnson signed an amendment to the Social Security Act which set the programs into law on July 30th, 1965. Medicare, the landmark program for seniors, now enrolls 55.2 million Americans. While a recent Kaiser Family