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Highlights
from the bio-innovation conference
Maine Science and Technology Foundation
July 15, 2002
DAY
TWO
Drug
Approval Strategies and Pitfalls in the U.S. and Abroad
Prof.
James O'Reilly, Esq., University of Cincinnati College
of Law, Cincinnati, OH
Linda
Horton, Esq., Hogan & Hartson LLP, Washington, DC
Moderator:
Prof. William Murphy, Franklin Pierce Law Center, Concord,
NH
Bringing
new drugs to consumer markets costs money, time, and
nerves. Jim O'Reilly likened drug development to a steeplechase
and listed 10 barriers to Food and Drug Administration
(FDA) approval for a new drug.
O'Reilly's
list began with preclinical data review, where research
is conducted in animals and most compounds "fade away"
before ever being tested in human clinical trials. The
last barrier on his list was conditional FDA approvals
and warning labels, which he said can cause difficulties
with investors.
Another
problem for drug developers, said O'Reilly, is "hypersensitivity
of the individual clinical review team within FDA toward
being burned, toward having a major side effect unseen…
[Further,] the medical review officer is pressured"
to make decisions within a fixed time period.
O'Reilly
said bad things can happen to clinical tests, so testers
must learn to handle challenges. Though some failed
applications for drug approval can be salvaged and new
trials begun under different conditions, sponsors must
remain patient and continue funding.
"You
can not shortchange the development process," said O'Reilly,
"and get by with quick and dirty studies in the face
of FDA's internal pressures to watch out for inadequate
or insufficient support."
And
negotiations with FDA don't always end at drug approval,
said O'Reilly.
"FDA's
letter will say you're approvable if you make the following
changes. If it's a biotech product that has some risk,
it might be restrictively labeled. Your negotiation
with the FDA at that point seeks to prevent you from
being in the very difficult position of being labeled
the drug of last resort."
O'Reilly
said meeting FDA requirements for drug development means
companies incorporate extra research time and bureaucratic
paper trails into their work. Another result, noted
in his presentation handouts, is that "biotech barriers
in the U.S. drive clinical work out of U.S. institutions."
Overseas
clinical trials raise other complications because different
countries observe different rules for drug approval.
Recent attempts to make the various systems more uniform
have resulted in "some baby steps toward harmonization,"
said Linda Horton.
Horton
cited several factors behind harmonization efforts.
"Public
health is international," she said. Since "microbes
do not respect boundaries," epidemics spread easily.
On the commercial side, "industries are international
and they need to have global standards" because many
clinical trials take place in multiple countries.
Horton
said scrutiny has increased because of controversial
trials in developing countries and a recent finding
that perhaps 80 percent of clinical trials in the United
Kingdom contain faulty data.
The
FDA has regulations governing international trials,
said Horton, and the agency can reject overseas data.
But, like most countries' drug regulatory agencies,
the FDA was established to work only within its own
borders.
Horton
named several efforts to harmonize pharmaceutical standards.
The International Conference for the Harmonization of
the Technical Requirements for the Registration of Pharmaceuticals
for Human Use (ICH) is establishing common ground in
preclinical data, clinical efficacy and safety and quality.
The
ICH operates within three regions: the European Union,
Japan, and the U.S., And is broadening within Asia and
the Americas. Another group, the Global Harmonization
Task Force, focuses on medical devices and covers Australia,
Canada, Europe, Japan and the U.S.
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