• This week, the U.S. Food and Drug Administration (FDA) issued new guidance on how pharmaceutical companies can change their Risk Evaluation and Mitigation Strategies (REMS)—plans that manage the known or potential serious risk associated with a particular drug or biologic. In 2012, the FDA announced it would review changes to approved REMS within 60 days. The new guidance aims to categorize changes to REMS “by the degree of their potential effect on the risk message and/or other REMS requirements.” Two new categories of REMS changes have been announced: revisions and modifications. As defined by the FDA, revisions are editorial in

    read more →
  • On April 9, 2015, The Hill published Glimmer of Hope in Reducing Prescription Drug Abuse, written by Michael Barnes, an Aimed Alliance coalition member. The op-ed highlights the positive work of the National Rx Drug Abuse Summit, which is taking place this week in Atlanta, GA and discusses how a comprehensive national effort to reduce prescription drug fraud, diversion, misuse and abuse is needed now more than ever, without sacrificing consumer access to high-quality health care. It calls for increased prescriber education so they can better fulfill their roles as gatekeepers in the drug supply chain. It also notes that

    read more →
  • Aimed Alliance supports the new bipartisan bill, the Patients’ Access to Treatments Act (PATA) of 2015 (H.R. 1600), introduced in the House of Representatives last week. If passed, PATA would assist patients suffering from chronic conditions, including HIV, hepatitis C, and cancer, in accessing medications by limiting some notorious third-party payer restrictions. PATA would place a cap on co-pays, coinsurance, and other out-of-pocket expenses for medications placed on specialty tiers. This legislation would help patients obtain individualized treatments most suitable to their needs that may have otherwise be unaffordable and adhere to treatment plans that could significant improve their quality

    read more →