Companies want quicker turnaround from FDA

Share this article:
While acknowledging improvements in the guidance they get from the FDA, the nation's pharmaceutical, biotechnology, and medical device companies still want faster turnaround times and other improvements.

According to results of a study by PricewaterhouseCoopers and Biocom, faster turnaround times were cited by 81% of all respondents as the area in which FDA improvement is most needed.
Results of this fourth survey found that FDA staffing shortages and turnover are the biggest ongoing issue. Some 61% of the firms surveyed agreed or strongly agreed that FDA personnel changes resulted in a break in continuity in at least one of their reviews.

Companies indicated a belief that FDA reviewers still cannot keep pace with reviews. More than half of respondents said goal timeframes have caused the agency to reject products simply because reviewers ran out of time to resolve issues. A minority of companies reported that FDA changed its position during product reviews, allegedly for no discernible scientific reason.

“This study is very important because the working relationship between the life sciences industry and FDA has a critical bearing on the health of Americans,” said Biocom president Joseph Panetta. “The good news is that these relationships have greatly improved since enactment of the Food and Drug Administration Modernization Act of 1997.”
Share this article:

Email Newsletters

More in News

Five things for pharma marketers to know: Thursday, August 21

Five things for pharma marketers to know: Thursday, ...

An Ebola survivor is set to leave Emory University Hospital, but the cause of the cure is uncertain, the FDA has approved a new type 1 diabetes test, and the ...

Sanofi expands Gaucher disease portfolio

Sanofi expands Gaucher disease portfolio

The oral medication Cerdelga joins Cerezyme in its Gaucher disease arsenal. Sanofi expects the drug will be priced "on par" with Cerezyme, which goes for around $300,000 a year in ...

Amicus seeks to upset Fabry market

Amicus seeks to upset Fabry market

Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm's oral drug.