To live is to complain. So why shouldn’t drugmakers, biotechs and device companies?

A new report out today says the FDA is making progress, but industry “remains concerned about a number of regulatory challenges,” and outlines a series of issues that still need to be resolved to improve product review delays and shorten the approval process via user fees.

The report was given birth by PricewaterhouseCoopers and BIOCOM, the trade group in Southern California, and was underwritten by Latham & Watkins, the big law firm. “The good news is that these relationships have greatly improved since enactment of the Food and DRug Administration Modernization Act of 1997 (FDAMA).” says Joe Panetta, BIOCOM’s ceo.

Here’s the bad news:

• A minority of companies surveyed indicated that the FDA changed its position during the review of product submissions, allegedly for no discernable scientific reason. While the number was small, the impact of the FDA changing its position can be significant on a company’s
development program;

• Faster turn-around times were most frequently cited - by 61 percent of respondents - as the area in which further FDA improvement is most needed;

• FDA staffing shortages and turnover remain the biggest ongoing issue for life sciences firms. Six in ten companies surveyed agreed or strongly agreed that FDA personnel changes resulted in a break of continuity in at least one of their reviews;

• The industry believes that FDA reviewers still can’t keep pace with review queues. More than half of all companies responding indicated that goal timeframes have caused FDA to reject products simply because reviewers run out of time to resolve issues;

• Congress authorized companies to pay user fees to remedy FDA’s chronic shortage of resources and accelerate product approval times. However, one-third of life sciences firms surveyed, including half of medical device firms, report that user fees haven’t decreased product approval times. This finding could prove significant as Congress debates PDUFA renewal.

All in all, this is a thinly disguised message that those proposed user fees are a good idea, because the FDA just can’t get the job done without industry money. Hmm…maybe if Congress - and the White House - shifted their funding priorities, the public wouldn’t have to rely on industry dollars to pay for government reviews.

Look here to see more on the survey.
[tags]PDUFA[/tags]