Newsletter - June 6, 2019
RTT Fizzles While FDA Increases Support for Compassionate Use Program
A year after the federal Right to Try (RTT) Act became law, there have been only 2 reported cases where the law was used to provide treatments to patients. During the same time hundreds of compassionate use INDs were approved by the FDA. It is no secret that the RTT was designed to circumvent FDA review...Read More
Does FDA Support Industry Charging High Prices for New Drugs?
Traditionally FDA officials have avoided directly inserting the Agency in the discussion on the ethics of high drug prices, till this week. This week, the FDA commissioner (acting) made an off-hand comment at a conference that seems to justify the $2.1 million price tag on a recently approved gene therapy from Novartis...Read More
RTT Fizzles While FDA Increases Support for Compassionate Use Program
A year after the federal Right to Try (RTT) Act became law, there have been only 2 reported cases where the law was used to provide treatments to patients. During the same time hundreds of compassionate use INDs were approved by the FDA. It is no secret that the RTT was designed to circumvent FDA review...Read More
Does FDA Support Industry Charging High Prices for New Drugs?
Traditionally FDA officials have avoided directly inserting the Agency in the discussion on the ethics of high drug prices, till this week. This week, the FDA commissioner (acting) made an off-hand comment at a conference that seems to justify the $2.1 million price tag on a recently approved gene therapy from Novartis...Read More