Senators criticize iPLEDGE
A bipartisan group of senators, including Dick Durbin (D-Ill.), Judd Gregg (R-N.H.) and Orrin Hatch (R-Utah), are calling on FDA to fix the iPLEDGE risk management plan covering Roche's Accutane and isotretinoin generics. In a letter to FDA, the senators express concern that the program increases the risks of therapy by unnecessarily causing extended use. The group also complains that iPLEDGE has caused some physicians to stop prescribing the drug. The risk management plan went into effect March 1 (1"The Pink Sheet" Feb. 20, 2006, p. 14)...
You may also be interested in...
Implementation of the iPLEDGE pregnancy risk management program for Roche's acne therapy Accutane and isotretinoin generics should be postponed until May 1, the American Academy of Dermatology said
A patient recruiter got 10 years in prison for his role in a scheme to convince seniors to get unneeded and expensive genetic tests. Nicholas McQuaid, acting assistant attorney general of the Justice Department’s Criminal Division, discussed the case.
Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.