Six current and former female pharmaceutical sales representatives have filed a $100-million gender discrimination lawsuit against Daiichi Sankyo in a US district court. The company employs around 3000 people in the US. Read more »

Federal law enforcers are looking hard at pharmaceutical manufacturers that put consumers at risk by cutting corners on product quality and safety and violating current good manufacturing practices (cGMPs). The Department of Justice (DOJ) is “taking an especially hard look” at situations that compromise drug safety, identity and quality, explained DOJ deputy assistant attorney general Maame Ewusi-Mensah Frimpong at this week’s CBI Compliance Conference in Washington, D.C. Read more »

In the dog-eat-dog world of federal deficit reduction in the US, there seems to be one health-related spending cut with broad bi-partisan support:  require drug companies to give the federal government “a better deal on medications for low-income people on Medicare.” Nearly 70% of respondents  back this strategy, according to a survey sponsored by the Kaiser Family Foundation (KFF), the Robert Wood Johnson Foundation and the Harvard School of Public Health. That’s far more than the mere 32% who want to raise Medicare premiums or the 26% who support a higher Medicare eligibility age (67, up from 65 years). Read more »

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages. Read more »

With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class. Read more »

Shortages of certain sterile injectables pushed some practices to source these products from unapproved distributers. Back in February 2012, counterfeit versions of Roche/Genentech’s cancer drug, Avastin, appeared in the US, prompting FDA to send letters to practices that had purchased drugs from several foreign distributers, including Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions, and Bridgewater Medical. Read more »

Endo Pharmaceuticals, maker of the opioid medication Opana ER (oxymorphone HCl), is suing FDA to prevent generic manufacturers from entering the market with formulations of oxymorphone that are not abuse-resistant. Read more »

Recent change likely to boost drug coverage by plans, but with variation in formularies.

Health plans offering coverage to individuals and small companies are more likely to cover multiple drugs in each class or category under revised regulations proposed by the Department of Health and Human Services in November. A key change in rules to implement the Affordable Care Act (ACA) is regarded as a big win for pharma, as some 20 million Americans are expected to enroll in plans sold through exchanges, greatly expanding the market for prescription drugs. Read more »

In the wake of the meningitis outbreak caused by contaminated compounded medications produced by the New England Compounding Center (NECC), both the government and the public have been wrestling with the question of how this happened—how did a company producing substandard medicines slip through regulatory oversight? Read more »