FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start

Posted 04 April 2012 | By Alexander Gaffney, RAC 

A fund established under the Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007 is beginning to ramp up activity after several years of cash-strapped stagnation, but not everyone is happy about the move, reports National Public Radio (NPR).

The Reagan-Udall Foundation was created under FDAAA to create an outlet for FDA, industry, academia and patient groups to come together to fund mutually beneficial activities.

"The idea was that this foundation could do things FDA can't," explains NPR. "It would raise money from private sources, fund research in areas where FDA lacks expertise, and organize collaborations involving industry, patient groups and academia."

But congressional concerns about industry's influence on FDA succeeded in blocking much of the group's funding from ever materializing, and the group has largely been a non-factor since its founding, reports NPR.

That funding situation is changing, says NPR, after the Foundation received a $150,000 grant in 2010 from the PhRMA Foundation and a $1,000,000 grant from the Bill & Melinda Gates Foundation. With that money, the group plans to start tackling some of the largest problems in product regulation, reports NPR.

"One major project the foundation is planning will develop new methods to better monitor the safety of drugs after they've been approved and hit the market," writes NPR. "The FDA wants to use large databases of anonymous medical records to search for signs a drug might be causing problems."

With additional funding scheduled to finally be released to the Foundation from FDA, the fund could see increased growth in the coming years.

"I see it as really an exciting opportunity and one that we really desperately need to have in place, to have it up and running," says FDA Commissioner Margaret Hamburg. "I think that we're already starting to see the benefits that it can offer."

Read more:

NPR - FDA To Fund Controversial Research Foundation

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles