Ever since Gilead Sciences Inc. unveiled its $84,000 price tag for Solvaldi, a breakthrough hepatitis C drug, many lawmakers, patient groups and payers have been throwing warning flags about the escalating price of drugs.
In the first hearing of the lame duck session of Congress, the Senate Appropriations Committee looked at the government's response to the Ebola crisis and considered the president's request for $6.2 billion in emergency funding to help contain the outbreak.
Arguing against the FDA's effort to retroactively fill a "substantial gap" in its regulatory framework for analyzing complex, naturally derived mixtures for exclusivity purposes, Omthera Pharmaceuticals Inc. petitioned the agency to grant five-year new chemical entity (NCE) exclusivity to its prescription fish oil drug Epanova.
The Oncologic Drugs Advisory Committee (ODAC) gave a green light Thursday to Rockwell Medical Inc.'s lead candidate, an iron maintenance therapy for dialysis patients with stage V chronic kidney disease.
A shift in congressional power, coupled with the momentum being built by the 21st Century Cures Initiative, is set to deliver significant changes to the FDA in 2015.
With the FDA already reviewing its first biosimilar applications, several patient advocacy groups are banding together to ensure the agency listens to the patient voice as it makes approval decisions and develops future biosimilar guidance.
