The biggest danger, said Janet
Woodcock, director of the FDA's
Center for Drug Evaluation and Research, is 'where public criticism and
controversy outweigh science.' Deliberations should be made based on the latest
science, she said, but controversy affects how the agency works and creates
what she called a 'circling of the wagons,' a 'let's not be too innovative'
She noted that the agency approved 10 cancer drugs in the
last fiscal year and is on track to do so again this year, but it is work the
FDA should not be doing alone. 'It is the job of the larger biomedical
community in concert with FDA' to get new drugs on the market, she said.
Some drug makers are wary of using innovative approaches
with the FDA. 'Once we get to the clinical study, if we want to be innovative,
we have to do the traditional approach alongside, sort of carrying two tracks
to get the product to market,' said Joseph
DeGeorge of Merck Research Laboratories.
Many challenges to new drug approval start well before a
drug finds its way to the FDA. Jonathan
Leff of Warburg Pincus noted
that venture capital investment in life sciences has been decreasing
dramatically, and in the first nine months of this year, the number of
first-time companies receiving venture capital investment was the lowest it has
been since 1995. Those venture capital firms that are investing, he added, are
shifting their investments to other countries or in less innovative products.
'We have tremendous opportunity to translate science that is happening into
cures, but the system isn't working as well as it needs to,' he said. 'We are
not getting the throughput. We need to address the issues of translating
scientific discoveries to new therapies.'
Some stakeholders are finding ways to assist the FDA in the
Insel of JDRF said his organization
decided it had a role in educating the agency in novel treatments and their
development. And when JDRF wanted to work on an artificial pancreas, there was
no regulatory guidance. So with the FDA's knowledge, the group convened opinion
leaders and created draft guidance that was submitted to the FDA. This helped
the FDA draft its own regulatory guidance for the artificial pancreas, which
just came out in final form.
Douglas with Austen BioInnovation Institute
said his organization decided to bring the FDA in earlier in the process and
found that things went smoother. 'We spent a lot of time trying to figure out
how to approach the FDA to make them feel they were in a safe harbor for
collaboration,' he said.
The panelists agreed that bringing patient foundations, as
well as the patients and families, into the regulatory process to discuss risks
and benefits of individual drugs is vital. 'We need to hear from affected
communities about what tradeoffs they think are acceptable,' said Woodcock.
'That should be our guiding light.'
The innovative spirit that is evident at the highest levels
of the FDA need to be transitioned to the practitioners of the review process,
Douglas noted that as the FDA collaborates more, it should
identify other bodies that can be brought in to help with reviews.
Woodcock noted that the workload at the FDA continues to be
a problem. It is hard to feel innovative when you are facing a mountain of
paperwork, she said.
Anderson noted that the Alliance
for a Stronger FDA, which she urged attendees to support, is focused on
increasing the agency's budget.
One panelist answered the question with praise. 'The FDA
environment, in terms of helping to advance and stimulate innovation, is better
today than it has been in a while, and that is a credit to the leadership,'