FDAnews Drug Daily Bulletin

With the final FDA user fee legislation lacking language to support a national track-and-trace system for pharmaceuticals, Congress must now act fast to preempt California’s epedigree law, slated to go into effect in 2015, Sen. Michael Bennet (D-Colo.) says.

The FDA has outlined provisional trial designs, study endpoints and efficacy analyses that can be used for testing and assessing new irritable bowel syndrome (IBS) drugs until a well-defined and reliable patient-reported outcome (PRO) tool — the ideal efficacy assessment instrument — can be developed.

The FDA appears to be taking steps to launch its much-delayed Secure Supply Chain Pilot Program (SSCPP), coincidently the same week that efforts to authorize a federal track-and-trace system in an FDA user fee bill died.

The FDA has sent contract repackager Shamrock Medical a warning letter for labeling drugs with the wrong strength.

OxyContin is set to go off patent next year, but the maker of the powerful and widely abused prescription painkiller is trying to extend its exclusive rights to the drug, arguing that a new version it spent $100 million to develop might substantially curtail abuse.

Vertex Pharmaceuticals’ two-drug therapy significantly improved lung function in patients with the most common genetic mutation causing cystic fibrosis, according to final results from a mid-stage study announced Thursday.

Shire’s Gaucher disease drug Vpriv significantly improved lumbar spine bone density, while Sanofi’s Cerezyme did not, according to results from a head-to-head clinical trial presented on Thursday.

Shionogi announced that the FDA has accepted for review the ospemifene new drug application (NDA) for the treatment of vulvar and vaginal atrophy due to menopause, including moderate to severe symptoms of dyspareunia (painful sexual intercourse) and/or vaginal dryness and physiological changes.

The U.S. Food and Drug Administration will soon have a new nanotechnology safety program, thanks to language tucked into a massive legislative package that’s on its way to President Obama.