Thursday, February 1, 2018

Man Must Pay $3.5M in Restitution for Role in Compounding Drug Scheme

Man Must Pay $3.5M in Restitution for Role in Drug Scheme

U.S. News & World Report-23 minutes ago
Man Must Pay $3.5M in Restitution for Role in Drug Scheme. A high school guidance counselor must pay nearly $3.5 million in restitution for his role in a ring that defrauded the state's health benefits plan and other insurers by submitting prescriptions for unnecessary compounded drugs. Feb. 1, 2018, at 4:07 p.m.. Man Must ...

Lawyers claim last 2 Texas executions botched by old drugs - and ...

Chron.com-1 hour ago
"It looks like Texas might have caused a botched execution by using substandard compounded drugs that they knew had passed their original beyond use date," said Maya Foa, an expert who works with pharmaceutical companies on protecting medicines from misuse in executions. "They have systematically flouted the ...

Gottlieb Lays Out Risk-Based Approach For Compounding GMPs ...

Inside Health Policy-3 hours ago
FDA Commissioner Scott Gottlieb told legislators Tuesday (Jan. 30) that FDA will take a risk-based approach to both the yet-to-be-finalized 503B-lite category of compounders and the new model agreement between states and FDA on oversight of compounders that ship products out of state. Gottlieb emphasized that FDA ...

Carter Alleges FDA Guidance Improperly Drives Compounding ...

Inside Health Policy-3 hours ago
FDA came under fire from Rep. Buddy Carter (R-GA) Tuesday (Jan. 30) for what he alleges is the agency's use of guidance documents as the basis for compounding enforcement actions. Carter's concerns were buoyed by a new policy from the Department of Justice which bars use of guidance to create binding standards, ...

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season

As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices. Continue reading