More Proof FDA Is Faster Than Other Drug
Regulators
This guest post was written by Joseph Ross, an
assistant professor of medicine at the Yale University School of Medicine and
Nicholas Downing, a third year medical student, also of Yale University School
of Medicine. Ross has done extensive study of how new drugs are approved. In
this article, they provide more evidence that the FDA’s review process is not
longer than that in other countries. (FiDA blog bold added.)
Last month, we published with our colleagues a study in the New England Journal of Medicine
examining the time required by three prominent pharmaceutical regulators to
review applications for new drugs that have never before had medical uses.
Our main finding: the FDA was nearly two months
faster than the European Medicines Agency and Health
Canada, the primary regulators for the European Union and Canada. This is true
both for the time it takes for the FDA to do the first regulatory review and
for total regulatory review time of these applications.
But our original measure of regulatory review
time only included the time an application actually spends being reviewed by
the FDA and its peers. For some drugs, the total time can be longer, as a
company may need to conduct additional research before resubmitting a drug to
regulators. Investors and industry are focused on the total time it takes to go
from submission to approval.
So we re-crunched the numbers. Our analysis is
limited because it included only applications that were eventually approved,
since only this information is made publicly available by all three regulators.
But we found more proof that the FDA is faster
than its peers.
As
can be seen in the accompanying figure(on website), the FDA was the fastest of the three
agencies, even when we look at the total time from submission to approval,
including time when both the agency and the industry applicant were “on the
clock”. The median time to approval was 322 days at the FDA, compared to 366
days at the EMA and 409 days at Health Canada.
Our comparison is complicated by the fact that
all three regulators do not behave in the same way, but we would expect that to
make the FDA look slower – and it doesn’t. Among these applications that were
eventually approved, the EMA approved almost every one in a single review
cycle, 96%, whereas 3% required two cycles and 1% required three cycles. In
contrast, 62% and 69% of applications were approved by the FDA and Health
Canada in a single review cycle, respectively. More than 30% of applications
required multiple reviews before approval. For the FDA, 36% required two cycles
and 1% required three cycles; for Health Canada, 24% required two cycles, 4%
required three cycles and 3% required four or more cycles.
You might think that extra requests for
statistical analysis, data collection, or even new clinical trials would make
the FDA process more time-consuming than that in other countries, but it
doesn’t.
Nevertheless, there are more nuances to this
story. You can see in the Figure that there was much more variation in time to
approval among applications to the FDA. More than half of approvals were
complete within one year, but there were many examples of the FDA requiring
800, 1000, even 1200 total days before approval. For instance, the well-known
anti-cancer drugs Sanofi‘s Eloxatin and Novartis‘
Gleevec were both approved in less than 80 days, however it took more than 10
years from initial submission to approval for Sabril, and anti-seizure
medication, and Asclera, a sclerosing agent to treat varicose veins.
A lot of
the variation in FDA time to approval can be attributed to whether one or more
cycles of review were required. Among the 62% of applications the FDA approved
after a single review, the median time to approval was 278 days. In contrast,
the median time to approval was 765 days among the 38% of applications that
required multiple cycles of review.
Interestingly, applications within the
hematology, oncology, and immune-modulating and anti-infective therapeutic
classes were most likely to receive FDA approval after a single review.
Applications within the musculoskeletal and pain and psychiatry and central
nervous system therapeutic classes were most likely to require multiple cycles
of review.
It is important to point out that there is no
right review speed or right number of cycles of review. The FDA may have been
acting appropriately in these slower reviews that required additional cycles.
These applications could have raised important safety concerns or included
poorly designed trials that could not support approval. Perhaps the FDA was
right to request more statistical analysis, additional data collection, or even
new trials, from the applicants.
One can argue that FDA has been cautious in ways
that benefit the public. There are certainly cases where the FDA did not
approve a drug, and other countries did only to have to withdraw it for safety
reasons. Examples would include Acomplia for obesity and Thelin for pulmonary
arterial hypertension. On the other hand, some medicines, like AstraZeneca‘s
Iressa for lung cancer or perfenidone for idiopathic pulmonary fibrosis, are
being used in other countries but are restricted or not approved by the FDA.
But either way, a tortoise-like pace is not one of the FDA’s problems.
Comment: Joleen
Chambers
Thank you for your research! After a family member experienced a serious adverse event
from a failed implanted medical device designed by the Mayo surgeon and
approved by FDA without clinical testing, I began advocating for safer
implanted medical devices.
Legislation to renew MDUFA must be complete by September 2012, yet the
medical device industry is balking at contributing financially to oversight
that would protect patients from harm.
The 'talking points' are focused on speeding 'innovations' to a
(unconfirmed & DTC marketed) demanding and growing pool of desperate patients
and the need to maintain jobs-at-all-cost for workers in the profitable medical
device industry. Bill Walton has
been hired to lobby Congress. The industry threatens that if it is not placated
they will go to other countries.
Let them go so there are fewer American victims in medical and legal purgatory!
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