Advocacy Groups Sue FDA For Trial Data From Its Accelerated Review Of Hep C Drugs
The approval process for Gilead's Sovaldi and Harvoni was fast tracked by the Food and Drug Administration due to the medications' breakthrough designation, but two health groups want the clinical trial records to see if there were gaps in drug efficacy or unidentified side effects. Meanwhile, the New York Times' reports on how the tobacco lobby is turning to the U.S. Chamber of Commerce to fight a new wave of anti-smoking legislation around the world.
The Wall Street Journal's Pharmalot:
FDA Is Sued By Advocacy Groups That Want Gilead Hepatitis C Trial Data
File this under ‘Show me the data.’ A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information. (Silverman, 6/29)
The New York Times:
U.S. Chamber Works Globally To Fight Antismoking Measures
When it came time to defend the tobacco industry, a man named Taras Kachka spoke up. He argued that several “fantastic tobacco companies” had bought up Soviet-era factories and modernized them, and now they were exporting tobacco to many other countries. It was in Ukraine’s national interest, he said, to support investors in the country, even though they do not sell tobacco to Australia. Mr. Kachka was not a tobacco lobbyist or farmer or factory owner. He was the head of a Ukrainian affiliate of the U.S. Chamber of Commerce, America’s largest trade group. (Hakim, 6/30)