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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

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

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...