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

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% ...

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.

Shire, AbbVie join forces for $55B

Shire, AbbVie join forces for $55B

The deal includes a $1.6-billion fee if AbbVie tries to walk away.

Next target for hep. C drugmakers: co-infections

Next target for hep. C drugmakers: co-infections

An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.