I-Team: Company Behind EpiPen Fought to Keep Cheaper Generic off Market

Chris Glorioso and Evan Stulberger, NBC4 New York August 31, 2016 The CEO of Mylan Pharmaceuticals announced the launch of its own cheaper version of the EpiPen this week on the heels of a price hike uproar. But for years, Mylan and its business partners have fought fiercely behind the scenes to block a cheaper generic from…

D.C. Week: NOAC Reversal Drug Stalls at FDA

Shannon Firth, MedPage Today August 20, 2016 […] PDUFA Again: Still Trying to Get It Right Industry and patient representatives embraced the sixth version of the Prescription Drug User Fee Act, aka PDUFA, while consumer groups balked at the unabashed enthusiasm shown by their counterparts at a public meeting held by the FDA on Monday. As Marc…

Part D pricing trends

Sarah Karlin-Smith and Brett Norman, Politico With help from Mary Lee August 22, 2016 […] Quick Hits Whistleblower lawsuit — Medical device giant Medtronic is facing allegations that it promoted a device for uses not approved by FDA, leading to patient injuries and false claims submitted to government payers, STAT reports. The whistleblower suit alleges the…

Ask the expert: Is it okay to let my toddler use my iPad for nursery rhymes?

David Coleman, Irish Independent August 17, 2016 Parenting expert and clinical psychologist David Coleman on why a toddler should not use a tablet […]. Even if you limit your daughter’s tablet use to watching and listening to nursery rhymes, it is still bad for her. You need to get rid of the tablet and any other…

Whistleblower case contends surgical device maker misled FDA — and patients paid the price

Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.

In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands.

21st Century Cures Act: Yes or No? No: Act’s promise of quick cures is a brew of ultra-hype mixed with snake oil

Imagine that you or someone you love has a fatal disease with no proven treatment. Would you rather be given an unproven experimental treatment for free or would you want to pay more than $100,000 for the drug and hope it works
Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?

CMS panel tepid on interventions for patients with chronic venous disease

A panel of the Medicare Evidence Development and Coverage Advisory Committee of the CMS voted that it has moderate confidence that there is sufficient evidence for intervention that improves health outcomes for certain adults with chronic venous disease.

Physician, Patient Advocates: Don’t Exempt CME From Sunshine Reporting

The president of the National Center for Health Research said pharmaceutical and device companies sponsor most continuing medical education programs because they’ve got something to sell.

Dems’ Platform Highlights ACA, Reproductive Rights

By Joyce Frieden, MEDPAGE July 5, 2016 The Affordable Care Act (ACA), high prescription drug costs, and reproductive health all figure prominently in the Democratic Party’s new draft platform. The draft platform, released Friday, touched several other items of interest to health analysts, including community health centers, gun violence, and mental health. The health insurance…

Selling Side Effects: Big Pharma’s Marketing Machine

By Michelle Llamas, Drugwatch 2016 Convincing people they are sick and need a drug is a multi-billion dollar industry. In 2015, Big Pharma dropped a record-breaking $5.4 billion on direct-to-consumer (DTC) ads, according to Kantar Media. And it paid off for Big Pharma. The same year, Americans spent a record $457 billion on prescription drugs. The U.S.…