The public persona of the US Food and Drug Administration (FDA) can ordinarily be described in a word: reserved. Its press releases frequently reveal an agency which hedges its statements, avoids hyperbole, and mostly steers clear of speculation.
But every now and again, it feels like bragging a bit.
Regulatory Braggadocio
Specifically, it feels like bragging about how it compares to its foreign regulatory counterparts like the European Medicines Agency (EMA). While there's no law or statute that requires the agency to best its regulatory counterparts, being able to measure up favorably to them helps to inoculate the agency against charges that it's approving products too slowly, later than other regulators, or otherwise doing so in an inefficient manner.
Those concerns were central to major FDA reforms in the 1990s which instituted industry-paid user fees meant to speed up review times and reduce so-called "drug lag"-the lag between when a drug is approved in another country (first) and in the US.
And with efforts to reform FDA now underway in the House Energy and Commerce Committee (E&C), the agency may be especially eager to show off some data indicating that, all things considered, it's actually doing quite well.
Study: Faster Approvals
In an 8 May 2014 posting on the agency's FDA Blog website, FDA Commissioner Margaret Hamburg laid out an extensive array of data from a recent study which compared the regulatory activities of the FDA, EMA and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
And with rare exception, FDA came out on top when it came to head-to-head comparisons between regulators, Hamburg said.
Take, for example, approval times.
| Median Approval Time (Days) |
|---|
| FDA | 304 |
| EMA | 342 |
| PMDA | 478 |
FDA handily beat both EMA and PMDA in this category, through PMDA has brought its average approval times down from its previous high of more than 800 days in 2006. When assessed from 2004 through the end of 2013, FDA has a median approval time of 304 days, EMA of 459 days and PMDA of 487 days.
All three regulators have become much more consistent in the time it takes to obtain approval, the data indicate.
Fastest Cancer Approvals-by Far
FDA is also notable for the speed with which it approves oncology and anti-infective drugs.
| Median Approval Time (Days) |
|---|
| FDA | EMA | PMDA |
| Anti-Cancer | 242 | 450 | 365 |
| Anti-Infective | 240 | 500 | 281 |
| Cardiovascular | 335 | 488 | 361 |
| Nervous System | 388 | 481 | 378 |
| Alimentary & Metabolism | 387 | 483 | 432 |
FDA approves cancer therapies almost twice as fast as EMA, and nearly four months sooner than PMDA.
The US regulator also had another mark of distinction, according to the study. The new substances it approved were approved in the US first in 76% of all cases. EMA came in second with 14%, and PMDA in distant third. While some of this is attributable to where a company chooses to file a drug first, that is thought to be-at least in part-a function of a stable and predictable regulatory environment.
The report is similar to one conducted in 2012 and published in the New England Journal of Medicine.
Device Progress
Separate from the report, FDA also touted new data indicating that its medical device division is "on track" to meet its commitments under the most recent Medical Device User Fee Act (MDUFA). Review times for 510(k) submissions have declined from 154 days in 2010 to 144 days in 2012, Hamburg said. That number is still considerably higher than the 90 days it took on average in 2005, and the 119 days it took as recently as 2008, according to the report.
Premarket applications, meanwhile, have shown significant improvements as well, taking just 297 days (cohort 98% complete) to come to a decision, down from 438 days in 2008 and 2009. Approval percentages have held mostly steady throughout this time as well, the data show.
FDA Voice Posting
CIRSI Report