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May 2017

Features

The next iterations of the Generic Drug User Fee Act and the Biosimilar User Fee Act are meant to encourage new generic and biosimilar products, but higher fees and budget reductions may threaten progress.
The authors summarize newly available HCV treatment regimens, their indications, studies supporting their efficacy and safety, and special considerations for each regimen, such as patient comorbidities.
Health Care & Law
The pharmacy benefit management (PBM) industry has recently fallen into the crosshairs of government investigations about the high cost of pharmaceuticals. The authors focus on the PBM-based P&T and formulary practices under scrutiny.
The new USP standard for handling hazardous drugs (HDs) will require millions of dollars in capital outlays for facility and equipment upgrades and also requires in-depth assessments of each HD that facilities handle, significant workflow and work practice changes, and thorough staff training.
Meeting Highlights
We report on selected research presented at the ACC 66th Annual Scientific Session and Expo, including sessions on proprotein convertase subtilisin/kexin type 9 inhibitors, anti-Xa anticoagulants, and a direct thrombin inhibitor.

Departments

Medication Errors
Speaking “off the cuff” is a prescription for disaster in health care
Prescription: Washington
Drug companies worry about new FDA “totality of evidence” standard
Approvals, new indications, regulatory activities, and more
Brodalumab (Siliq) for moderate-to-severe plaque psoriasis in adults; telotristat ethyl (Xermelo) for carcinoid syndrome diarrhea in combination with somatostatin analogue therapy in adults; and desmopressin acetate (Noctiva) for adults with nocturnal polyuria
Letter to the Editor
Drug Forecast
Otiprio: an FDA-approved ciprofloxacin suspension gel for pediatric otitis media