Monday, October 7, 2013

Hepatitis C - Four Ways that the US Government Shutdown Hurts Patients and Access to Medicines

Oct 2/ FDA Panel Review On For Gilead's Sofosbuvir Despite Government Shutdown
Sept 24/Gilead's (Sofosbuvir) FDA review could be delayed because of government shutdown?

FDA Antiviral Drugs Advisory Committee.
Information On October 25, 2013 Sofosbuvir Review
Information On October 24, 2013 Simeprevir Review

Four Ways that the US Government Shutdown Hurts Patients and Access to Medicines
Published: Oct 07, 2013
Written by: Christopher Ward
World Health Advocacy

Disease Surveillance and Outbreak Monitoring
Due to the furlough of its workers the Centers for Disease Control cannot monitor influenza outbreaks or other disease outbreaks thereby putting the public at risk from the spread of communicable diseases.

Medical Research and Product Approvals
Furloughs at the National Institutes of Health will bring many clinical research projects to a halt. Review panels for cutting edge new drugs for Hepatitis C are scheduled for October but won’t take place if the shut down continues, further delaying access to potentially live changing and life saving new treatments.

New and Generic Drug Registration and Approvals
Although user fees enable the FDA to continue to fund, in the short term, the review and registration of both new drug entities and generic drugs, the shut down prevents the FDA from collecting any user fees. If here is a prolonged shut down drug registrations and approvals will stop.

Medicines Supply
Any company that requires an FDA inspection before it can re-initiate operations is going to be delayed. In addition more than 70 percent of the active pharmaceutical ingredients used by multi national drug manufacturers are foreign sourced and the impacts of the shut down on port operations good be significant. Current drug shortages will be exacerbated and new drug shortages may soon emerge.

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