Archive for the ‘Drug Industry’ Category
Amid problems linked to FDA-approved drugs — including last year’s nationwide meningitis outbreak — some might be questioning what exactly makes a drug “safe.”
The Supreme Court yesterday in a 5-4 decision ruled that pharmaceutical sales representatives qualify as salespersons and thus are not entitled to overtime pay, the New York Times reports (Liptak, New York Times, 6/18). Federal labor law exempts outside salespersons from overtime pay requirements (Kendall, Wall Street Journal, 6/18).
The class-action lawsuit was filed by two former GlaxoSmithKline drug representatives, who claim they were not compensated for the additional 10 to 20 hours weekly they worked beyond their regular work hours to meet with physicians and other potential clients.
The Supreme Court yesterday heard oral arguments in a case that will determine whether pharmaceutical representatives are entitled to overtime pay, Reuters reports (Vicini, Reuters, 4/16).
The class-action lawsuit was filed by two former GlaxoSmithKline drug representatives, who claim they were not compensated for the additional 10 to 20 hours they worked each week beyond their regular work hours to meet with physicians and other potential clients (Sherman, AP/U-T San Diego, 4/16).
FDA yesterday announced that it temporarily will allow the importation of alternatives for Doxil and methotrexate, two cancer drugs that have been in short supply since November, the New York Times reports. The shortages of both treatments began after Ben Venue Laboratories temporarily closed an Ohio plant to address product safety concerns (Harris, New York Times, 2/21). Read the rest of this entry »
The U.S. Supreme Court on Monday agreed to hear a case that will determine whether pharmaceutical sales representatives are entitled to overtime pay. The court will review a class-action lawsuit brought by two former GlaxoSmithKline sales representatives.
The 9th U.S. Circuit Court of Appeals has sided with drugmakers against overtime pay, while the Department of Labor, the 2nd U.S. Circuit Court of Appeals and the plaintiffs say the sales representatives should receive the funds. Read the rest of this entry »
Merck has agreed to pay $950 million to settle allegations that it improperly marketed the pain medication Vioxx, the Department of Justice announced on Tuesday, the AP/Washington Post reports.
DOJ said its recent investigation showed Merck made false, unproven or misleading statements about the drug’s safety to boost sales. It also argued that the company lied to Medicaid agencies about Vioxx’s safety. Merck will pay $321.6 million in criminal fines and $628.4 million to settle civil charges.
From the settlement, the federal government will receive $426.4 million, while Medicaid programs in 43 states and the District of Columbia will receive $202 million (AP/Washington Post, 11/22). The company also signed a corporate integrity agreement that pledges to closely oversee drug promotion efforts and report them to the government (Wilson, New York Times, 11/22).
As part of the settlement, Merck also will plead guilty to marketing Vioxx as a treatment for rheumatoid arthritis without FDA approval (AP/Washington Post, 11/22).
The AP/San Diego Union-Tribune reports that FDA recently altered its stance on sodium thiopental, helping Arizona and California secure the elusive execution drug from overseas.
CBS reports on a recent federal investigation into drugs released by a GlaxoSmithKline subsidiary that was triggered by a whistle-blower’s tip.
Vanity Fair summarizes its recent feature story:
Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.