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The House Energy and Commerce Committee sent letters to three major pharmaceutical manufacturers demanding information on the role they may have played in helping trigger the opioid epidemic. The action is part of the panel’s probe into potential breakdowns in the drug supply chain. Read More
Medicare and its beneficiaries could save a whopping $2.8 billion on the 20 most commonly prescribed brand name drugs — even when accounting for the 17.5 percent average rebate for the drugs, the study says. Read More
Gottlieb said the program appears to be operating as intended (to make sure prescribers and pharmacists are instructed on the meds’ risks and safe uses), but he cautioned there may be more to be done as “a REMS can achieve functional compliance…but not fully achieve its intended public health purpose.” Read More
Last year, the agency estimated it had around 700 employees and predicted the move from London to Amsterdam would cost about 200 jobs. But it’s now predicting more staff reductions. Read More
The New Civil Liberties Alliance (NCLA) filed a petition asking the FDA to stop using ‘improper” agency guidance to impose obligations on drugmakers and instead issue clear rules and notice-and-comment procedures. Read More
Multi-district litigation over Roche’s anti-acne drug Accutane (Isotretinoin) hit a wall this week when the New Jersey Supreme Court ruled against allowing certain expert testimony. Read More
The European Medicines Agency said Wednesday it needs to scale back or suspend more activities, blaming Brexit for staff reductions that are disrupting its ability to function. Read More
FDA Commissioner Scott Gottlieb outlined what the agency hopes to learn from an advisory committee Friday at a meeting about safety measures for transmucosal immediate-release fentanyl (TIRF) products. Read More