Drug Companies Rushing To File With FDA May Want To Reconsider
September 16 2009 - 11:27AM
Dow Jones News
Drug companies rushing to meet year-end targets to apply for
U.S. regulatory approval of new drugs might want to slow down.
The Food and Drug Administration typically receives a higher
number of new drug applications in the final three months of the
year than at any other time of year. But these end-of-year
applications have the lowest rates of approval during FDA's first
crack at reviewing them, compared with submissions made during
other quarters, according to the agency.
In addition, while other fourth-quarter submissions may
ultimately be approved, the approval may not occur in as timely a
manner as other quarters.
Both regulators and industry insiders suspect the rush to meet
self-imposed corporate deadlines - possibly spurred by
employee-compensation incentives - leads to sloppier applications.
Errors and omissions in clinical data and other information can
cause the FDA to have more questions, forcing the agency to take
longer than the standard 10 months to make a decision.
"I personally believe people are pushing to submit things by the
end of the year for business reasons as opposed to 'It's ready,'"
said Robert Yetter, microbiologist with the FDA's Center for
Biologics Evaluation and Research, who addressed the issue in a
speech Tuesday at the Regulatory Affairs Professionals Society
conference in Philadelphia.
Yetter advises letting internal corporate deadlines slide if an
application isn't ready for prime time.
Douglas Hunt, senior director of global regulatory affairs at
drug and medical-device maker Baxter International Inc. (BAX),
acknowledged the industry's tendency to submit items by the end of
the year, though he tries to avoid this and to make sure Baxter's
applications are ready for review.
It should also be noted that issues at the FDA itself - such as
understaffing - may contribute to delays. Yetter said heavy
workloads sometimes result in FDA reviewers having new questions
about an application late in the review process, forcing a delay.
Baxter's Hunt said he has noticed an increase in such "late
questions" from FDA.
Consulting firm Booz Allen Hamilton conducted independent
evaluations of FDA's so-called "first-cycle" review performance.
The first cycle refers to the initial review period, which is
generally 10 months from submission for standard applications and
six months for those designated priority review because the drug
has potential to be a major advance in treatment. It's not uncommon
for FDA reviews to extend beyond these periods.
The timelines are governed by the Prescription Drug User Fee
Act, which authorizes FDA to collect fees from companies that apply
for agency approval of new drugs and other products.
Booz Allen found that 44% of applications filed between 2002 and
2007 were submitted in the final three months of those years, more
than twice as high as the next highest quarter, the second quarter.
But only 38% of fourth-quarter submissions were approved during the
FDA's first review cycle, versus an average of 51% for all
applications.
The time of year with the best odds? The third quarter, or July
through September, whose first-cycle approval rate exceeded
70%.
The timeliness of FDA action can make a big difference to
companies. Eli Lilly & Co. (LLY) and Daiichi Sankyo Co.
(4568.TO) had hoped their anti-clotting drug Effient would hit the
market sometime in 2008, having submitted it to FDA the day after
Christmas 2007. But the FDA extended its evaluation based on
additional information the companies provided during the first
cycle of the review, and the agency didn't approve the drug until
July 2009 - thus costing nearly a year's worth of sales for what
the companies hope will become a blockbuster.
Eli Lilly spokeswoman Tammy Hull said she didn't believe the
timing of the submission of Effient to FDA factored into the
delay.
"It was a very robust submission," she said. In a recent article
in The New England Journal of Medicine, an FDA reviewer said the
agency "grappled with a number of complex issues during the review
process," including the drug's risk of causing bleeding and a
drug-formulation issue.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com