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pharmaceutical 1306 articles

Senators Seek Federal Probe of EpiPen Maker For False Claims

Mylan, the embattled manufacturer of the lifesaving EpiPen, and CEO Heather Bresch, already under investigation for unscrupulous price hikes and shady business practices, could also find themselves facing a federal False Claims Act lawsuit before long. Three members of the Senate Judiciary Committee sent a letter to U.S. Attorney General Loretta Lynch Wednesday asking the Justice Department to investigate whether Mylan illegally wrongfully classified the EpiPen under the Medicaid Drug Rebate Program, which would allow it to repay a lower percentage of its sales to states in the form of rebates. Chairman Chuck Grassley, R-IA, and Sens. Richard Blumenthal, D-CT, and Amy Klobuchar, ... Read More

Chinese whistleblower says drugmaker Sanofi bribed doctors to increase sales

A whistleblower has come forward with allegations that French pharmaceutical giant Sanofi SA bribed hundreds of doctors in China in 2007 in a push to raise sales. The French multinational corporation produces a multitude of prescription and over-the-counter drugs, including the blockbusters Plavix, Allegra, and Avandia. According to Bloomberg, the whistleblower provided evidence to the 21st Century Business Herald, a newspaper based in the southern Chinese city Guangzhou, hiding behind the pseudonym “Pei Gen,” which translates to “bacon.” The paper said that although the man making the allegations remained anonymous, the nature of the materials he provided led staff to ... Read More

U.S., FDA sue Louisiana company for making and selling unapproved prescription drugs

A Shreveport, La., pharmaceutical company has been manufacturing and distributing unapproved and misbranded drug products for several years, even though U.S. Food and Drug Administration (FDA) inspectors discovered unlawful business practices within the company 13 years ago. According to the U.S. Justice Department, Sage Pharmaceuticals Inc. has ignored numerous FDA warnings to bring its drug and wound-treatment products into compliance with U.S. regulations. The U.S. government first obtained an injunction against the company in 2000, banning it from making and selling two new drugs that were never approved by the FDA. Since that time, however, FDA inspectors found that Sage ... Read More

Whistleblowers to get cut of record fines in health care fraud case

Drugmaker GlaxoSmithKline will pay a combined total of $3 billion in civil and criminal fines and plead guilty to pushing two of its popular drugs for unapproved purposes and withholding important safety information about a third drug from U.S. regulators. A group of whistleblowers instrumental to the case, which is considered to be the largest health care fraud settlement in U.S. history, will receive a percentage of the fines for their role in aiding the federal government’s investigation and helping to recover taxpayer money. At the center of the case was GSK’s illegal marketing of the drug Paxil to treat ... Read More

Big Pharma earns 77,500-percent return on lobbying investments, at taxpayers’ expense

Until November 2010, an opioid painkiller called Darvocet (Dextropropoxyphene) had been prescribed to millions of people since the 1950s, despite its known risks for overdose and heart arrhythmia. It remained on the market for decades, despite multiple attempts by safety groups to ban it. Pfizer’s anti-smoking drug Chantix is aggressively advertised and widely prescribed in the U.S., even though it consistently lands on lists of the most dangerous drugs in the U.S. and receives the FDA strongest possible warnings. DePuy Orthodpaedics manufactures an all-metal hip implant system that scores of patients blame for serious injuries stemming from the device’s early ... Read More

Injured Pfizer worker blows whistle on unpoliced biotech hazards

Becky McClain was a molecular biologist working for Pfizer Inc. when she was allegedly injured on the job after being exposed to a highly secretive virus in the company’s Groton, Connecticut, laboratories. McClain filed a number of complaints with Pfizer in an effort to address safety concerns that put both workers and the public at risk. But instead of fixing the problem, Pfizer turned its back on Ms. McClain’s complaints and fired her. Today, two years after winning a $1.27 million judgment against Pfizer and an additional $910,000 for attorney’s fees and punitive damages awarded by a judge last year, ... Read More

New study advises surgeons, patients avoid all-metal hip implants

A new study funded by the National Joint Registry of England and Wales and published this month in the British medical journal The Lancet calls on surgeons to stop using metal-on-metal hip implants completely, saying that evidence shows patients who receive the implants are much more likely to need revision surgery to have the implants repaired or replaced. The study’s authors analyzed data from the National Joint Registry of more than 400,000 hip replacements made from 2003 to 2011. While the vast majority of those surgeries involved traditional implants made of plastic or ceramic, more than 31,000 patients received metal-on-metal ... Read More

Study links SSRI use to dangerous pregnancy complication

Recent studies have shown that some types of antidepressants increase the risk for birth defects when mothers take them while pregnant. But new studies suggest that the medication may also cause problems with the pregnancy itself. The new study, published in the British Journal of Clinical Pharmacology found that pregnant women who use antidepressants known as selective serotonin reuptake inhibitors (SSRIs) have a slightly higher risk of developing dangerously high blood pressure, a condition known as preeclampsia that can be harmful for both mother and the unborn child. SSRIs are among the most prescribed medications in the United States, and ... Read More

DePuy ordered phase-out of defective hip implant after FDA inquiry

Johnson & Johnson decided to phase out one of the hip implants made by its subsidiary DePuy Orthopaedics and sell off its inventory shortly after receiving an inquiry from the Food and Drug Administration (FDA) that questioned the device’s safety and efficacy. The federal agency was asking the drug and medical device manufacturer for safety data on its metal-on-metal ASR XL Acetabulator hip replacement and hip resurfacing systems, and informed the company that blood tests in patients who had received the implants showed “high levels of metal ions.” The latest news adds more concern that DePuy and Johnson & Johnson ... Read More

Johnson & Johnson sold unapproved transvaginal mesh for years, report claims

Johnson & Johnson sold its Gynecare Prolift vaginal mesh for three years without obtaining approval for the product, according to a March 21 report by Bloomberg. The Prolift mesh, which the U.S. Food and Drug Administration (FDA) eventually approved for use in 2008, is now the source of about 550 personal injury lawsuits in the U.S., filed by women who allege the product malfunctioned and harmed them. To gain FDA approval, manufacturers of medical devices such as surgical mesh and bladder slings must demonstrate that the products either have passed required clinical tests for safety and efficacy or are sufficiently ... Read More