Pharma, public critique FDA's performance

A new survey shows a disconnect between consumers' assumptions about FDA regulation and reality. And it illustrates the agency's difficult balancing act between serving the industry it oversees and pleasing taxpayers who also help to fund it.

Just consider the survey's findings on user fees, a major source of funding for the agency. Designed to speed the process of drug approvals, user fees are paid by companies to help fund the resources FDA needs to review meds. Most of the companies surveyed by PricewaterhouseCoopers don't think the user fees speed up the review process, and less than a quarter think the FDA is spending them as intended.

That's one problem. But consumers have another beef: Some 70 percent of them think user fees shouldn't be part of the equation at all. In fact, more than a third of consumers didn't even know that user fees helped to fund the FDA's workings. A little more than one-fifth of companies think user fees create potential conflicts of interest, but that's a far cry from 70 percent. Meanwhile, more than one-third of American consumers say they've lost confidence in the FDA's ability to regulate the drug industry, after two years of repeated safety concerns and product recalls.

In commenting on the survey, PwC's Michael Mentesana encapsulated the seemingly impossible balancing act that FDA faces. "Consumers want safer, more effective drugs and devices and access to the latest medical innovation," Mentesana said. "Industry wants fast and efficient product approvals. And Congress wants better quality, lower cost healthcare that demonstrates enhanced economic and clinical value." 

- get the report from PwC
- see the Wall Street Journal post
- check out the PharmaTimes piece