FORBES BUSINESS | 6/19/2012 @ 10:15AM
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!