Outsourcing and Oversight: the FDA moves to tighten up drugmaker regs

The FDA will introduce stronger rules on safety and quality assurance for drug makers who outsource production, an agency official told an industry conference this week. According to the Wall Street Journal, the agency said it will likely soon “require co

The Insider: All this could be yours someday

Fuzzy logic As the “tax extenders” bill makes its way through the Senate, a provision to extend COBRA premium subsidies for the unemployed is in jeopardy. Opponents in the Senate and the Blue Dogs in the House who stripped the provision from legislation t

State gains in transparency, Rx legislation

Though much attention was focused on national reforms this spring, several states made moves toward greater transparency in the pharmaceutical industry, and toward curbing the industry’s marketing influence on prescribing. Connecticut passed a law requiri

Cross-coast Post: Real Choices

From our friends over at the Health Access Blog comes a great post about a California bill, SB890, that would implement many of the consumer protection pieces of national health reform early, like setting up strong medical loss ratios, so that insurers sp

The Insider: A broken record

Health Care Reform = Rationing has been a favorite theme of opponents throughout the debate.  While the circumstances and details change over time, this theme remains constant.  In the past week, opponents have stepped up their attacks on the nomination o

New study suggests academic detailing improves reliance on clinical guidelines

Α new study in the Archives of Internal Medicine suggests that academic detailing may improve physicians’ adherence to clinical guidelines, findings that boost AHRQ’s recent announcement to back 9000 academic detailing visits over the next three years. Us

FDA cracks down on misleading ads or promotions through new ‘Bad Ad’ program

Recently, FDA rolled out their 'Bad Ad' Program asking doctors and other health care providers to help ensure that ads and other promotions by the drug industry are “truthful and not misleading.” FDA rolled out the 'Bad Ad' Program a month ago to enlist h

Senate should restore COBRA and Medicaid subsidies

As we said Tuesday, the House removed provisions for federal Medicaid and COBRA subsidies from H.R. 4213, and the Senate departed for Memorial Day recess without taking action. The subsidies are critical to help hurting states that are struggling with bud

As FDA warns about IV bags, number of drug recalls on rise

Another drug recall occurred this week as the FDA has told providers to stop using contaminated IV medications made by Claris Lifesciences in a factory in India. Providers have been warned not to use the company's intravenous metronidazole, ondansetron, a