The Food and Drug Administration reviewed new drug applications significantly faster, and approved more new drugs first, than did its European and Canadian counterparts between 2001 and 2010.
These and other findings of practices at the three agencies raise question about whether speeding the review process further in the renewal of the Prescription Drug User Fee Act (PDUFA) is justified, according to Nicholas Downing, of Yale University, New Haven, Conn., and his associates. The findings were published May 16 in the New England Journal of Medicine.
Passed in 1992, PDUFA authorizes the FDA to collect fees from companies for each new drug application filed; the fees are used to speed of the review process, which includes hiring extra staff members. The law is reauthorized every 5 years, including this year (PDUFA V).
Previous renewals have identified areas of specific emphasis, such as drug safety and postmarketing surveillance (in 2007). This year, the FDA has worked with the pharmaceutical industry on how to make the new drug and biologic approval process more effective and efficient, and how to increase the number of agents approved in a single review cycle. The emphasis reflects "a response to criticism that the FDA has focused on safety at the expense of timely reviews," the researchers noted.
But their findings "contradict recent criticisms of the speed of review by the FDA and lead to question about whether the speed of the review process is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers."
Mr. Downing and his colleagues used publicly available information from the FDA, the European Medicines Agency (EMA) and Health Canada for 2001-2010 to compare the speed of review of new prescription drugs and biologics; they excluded reformulated drugs and combination drugs (N. Engl. J. Med. 2012 May 16 [doi:10.1056/NEJMsa1200223]).
Until their review, little objective information has been available regarding the time it takes the FDA to review applications for new therapeutic agents, and how that review time compares with those of agencies in other countries, they noted.
Of the 510 applications for new drugs that were approved during this time, 225 were approved by the FDA, 186 by the EMA, and 99 by Health Canada. Of these drugs, 289 were considered unique new therapeutic agents, including 72 that were approved by all three agencies.
There were no significant differences in the therapeutic drug class reviewed or whether a priority review was used between the three agencies, with one exception: the proportion of orphan products approved by the EMA was significantly higher than that of the FDA (28% vs. almost 17%).
Of the 289 new agents, 190 were approved in the United States and in Europe. Of these, 121 64%) were approved in the United States first. Of the 154 that were approved in the United States and in Canada, 132 (86%) were first approved in the United States.
Most of the new agents were approved within a single cycle, but the rate was highest at the EMA (96%) compared with 62% at the FDA and 69% at Health Canada.
The median time to complete the first review (the number of days from the time the application was submitted to the date the agency notified the applicant of its decision) was 303 days for FDA-approved applications, 366 days for the EMA, and 352 days for Health Canada – a statistically significant difference across the agencies.
For the 72 new agents approved by all three agencies, the median time of the first review was about 100 days faster at the FDA: 254 days, compared with a median of 356 days at the EMA and 346 days at Health Canada.
The study was supported by the Pew Charitable Trusts. The authors disclosed no relevant conflicts of interest.