Despite Complaints About FDA’s Right-To-Try Approach, Watchdog Says It’s Mostly Doing A Good Job
The Government Accountability Office did say the agency could do better at providing clear and transparent information about potential side effects of the experimental drugs. In other pharmaceutical news: the House passed an Food and Drug Administration authorization bill, President Donald Trump considers scaling down a program that makes drugmakers give discounted products to hospitals, and a new method might help shave off development time for drugs.
FDA Gets Good Marks On Compassionate Use, Except For ...
Despite widespread criticism, a new report finds the Food and Drug Administration made useful changes to a controversial program that provides access to experimental medicines. However, the agency still needs to do a better job of explaining how patient side effect data can influence drug approval decisions, according to the U.S. Government Accountability Office analysis. Not surprisingly, the findings prompted the same sort of bickering sparked by the program, itself. (Silverman, 7/12)
House Passes Bipartisan FDA User Fee Bill
The House of Representatives passed bipartisan legislation Wednesday that reauthorizes the FDA's ability to collect user fees from drug and device makers, as policymakers look to avoid thousands of layoffs if the current agreement expires. The FDA user fee agreements, which are renegotiated every five years with the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, fund much of the FDA's operations. (Kacik, 7/12)
CQ Roll Call:
House Passes Key FDA User Fee Bill
The House on Wednesday passed by voice vote a key Food and Drug Administration authorization bill, setting up a Senate vote in the coming weeks that might not be quite so easy. The bill (HR 2430) would renew the FDA’s authority to collect fees from the prescription drug and medical device industries. Industry fees make up about $2 billion of the FDA’s nearly $5 billion budget. The bill would set new fee levels for fiscal years 2018-2022, and lawmakers have added other policy changes. It also would require the FDA to prioritize the approval of certain generic drugs and set up a system for the regulation of hearing aids that don’t require a prescription. (Siddons, 7/12)
Trump May Be Backing Off From Plan To Scale Down 340B
Hospital lobbying groups say they're hearing President Donald Trump may be backing off plans to scale back a federal program that requires drugmakers to give discounted products to hospitals that treat a high number of poor patients. A proposed executive order on drug pricing from the Trump administration leaked late last month contained language that directed the HHS Secretary to find ways to reduce the size of the 340B program. (Dickson, 7/12)
Bin Chen: Cutting To The Chase With Computational Biology
The in silico approach to drug development just got a taste of validation, thanks to some intriguing new research from University of San Francisco, California. A drug cherry-picked with algorithms has behaved as expected: It’s helped shrink tumors in animal models. The UCSF researchers have created a computational method to delve through enormous amounts of open-access data to find novel drugs — and also discover new ways to repurpose existing drugs. The work was just published in Nature Communications. (Keshavan, 7/13)