After Trump Meets With Pharma CEO, FDA Yanks Request For Company To Run Additional Drug Trial
Instead, Amicus Therapeutics gets the go-ahead by the agency to submit its treatment of a deadly rare disease for review. Meanwhile, a new analysis finds that there is only limited room for improvement in terms of the agency's speed for approving drugs.
FDA Reverses Course On Drug Developed By CEO With Ties To Trump
The Food and Drug Administration has changed its tune on an experimental drug for a deadly rare disease, withdrawing a request that the company developing it run another clinical trial. The unusual move comes after President Trump met with the company’s CEO —and promised to speed up what he called a “slow and burdensome” process for drug approvals. Amicus Therapeutics, a New Jersey biotech company, announced on Tuesday morning that the FDA had given it the all-clear to submit for review its treatment for Fabry disease, an inherited disorder that often leads to fatal organ damage. (Garde, 7/11)
Does The FDA Need Pep Pills To Review Drugs Any Faster?
After examining all 15 drugs approved between 2011 and 2015 by the cardio-renal division — purportedly, the slowest of FDA divisions — a pair of researchers believe there is “limited opportunity” to speed approvals by reducing the time taken for agency reviews and decision making. Instead, the authors suggested that drug makers could move more quickly to prepare applications.The analysis, which was published in BMJ, was undertaken in response to criticism the FDA is too slow to approve medicines, even though studies have found the agency compares favorably with regulators elsewhere. (Silverman, 7/10)
And in other news about the agency —
CQ Roll Call:
House Expected To Vote On FDA Bill Wednesday
The House is expected to vote Wednesday on an updated version of a key Food and Drug Administration reauthorization bill, according to a congressional aide and multiple lobbyists. The House Energy and Commerce Committee on Monday evening released an updated version of the bill (HR 2430) that incorporated amendments adopted during a June 7 markup, as well as other changes. (Siddons, 7/10)