Consumers, companies see room to improve at FDA

Companies and consumers both feel the U.S. Food and Drug Administration does a good job, but high-profile drug recalls have damaged the average American’s faith in the agency, according to a report published on Tuesday.

Executives at 50 medical companies think FDA has improved it relationships with them, but say the agency is not keeping up with advances in technology, the survey by PricewaterhouseCoopers LLP and Biocom, an association of 550 California life sciences companies, found.

PwC and Biocom interviewed 1,000 adults and executives at 50 drug, device and diagnostics companies of varying sizes for the report, available at http://www.pwc.com/us/fdasurvey.

Among the companies, 80 percent said FDA is providing better guidance about its expectations but just 38 percent said the overall working relationship with FDA has improved over the past two years.

Only 8 percent of drug and device makers said FDA is doing enough to advance personalized medicine.

While 93 percent of U.S. consumers are confident about the safety and effectiveness of drugs and medical devices approved by the FDA, 56 percent said they would be willing to use drugs and devices approved outside the United States.

More than 50 percent of consumers said they think FDA does a good job, but 36 percent said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.

“Consumers want safer, more effective drugs and devices and access to the latest medical innovation. Industry wants fast and efficient product approvals,” PWC’s Michael Mentesana said in a statement.

“But the promise of faster product development has yet to be realized and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations.”

One of the most misunderstood areas is the Prescription Drug User Fee Act or PDUFA, which requires companies that make drugs pay up to $1.25 million per drug application.

FDA says this cash has helped speed up drug approvals but the survey found that 46 percent of company executives do not believe approvals are any faster.

And 70 percent of consumers disapprove of having companies help pay for FDA’s work. Only 36 percent knew that industry helps pay for FDA and just 68 percent fully understood the agency is paid for by taxes.

(Reporting by Maggie Fox; Editing by Jackie Frank)