Posted 27 January 2015
By Alexander Gaffney, RAC
A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device approval processes, resulting in new products reaching consumers more quickly.
PWC's report, The FDA and industry: A recipe for collaborating in the New Health Economy, is a wide-ranging look at FDA's performance and industry's assessment of its interactions with the regulator.
Falling Approval Times—Mostly
One improvement—from the perspective of industry—at FDA has been a fall in the number of months it takes to conduct a "standard" review for drugs and medical devices. As of 2012, FDA approved premarket approval applications (PMAs) in half the time (7 months) than it did just three years earlier in 2009 (14 months). Reviews of new drugs and biologics, which are performed under new drug applications (NDAs) or biologics licensing applications (BLAs) also saw an improvement in review time from 13 months in 2008 to 10 months in 2010, 2011 and 2012.
Even as standard reviews see sustained improvements, the report notes that priority reviews—reviews intended to accelerate the assessment of products for which there is a high unmet need—haven't always been as consistent. For devices, for example, FDA actually got worse since 2008, when it approved devices subject to priority review in just 6 months. A year later, it approved those devices in 16 months. As of 2012, it approved them in 8 months—still higher than its 2008 average.
Drugs, however, saw a sustained improvement over the same time period. FDA approved new drugs subject to priority review in 11 months on average in 2008. As of 2011 and 2012, that number was 6 months—the target set by the Prescription Drug User Fee Act (PDUFA).
It's worth noting that PWC's charts track "FDA time"—not calendar time. So while a drug or device may have taken 6 or 10 months for FDA to review, the time between the submission of an application and actual approval may have taken a little bit—or a lot—longer.
A key statistic also found in PWC's report is the number of drugs subject to first-cycle approvals. This metric can be seen as a proxy for either FDA's willingness to approve new drugs, the quality of new drug applications being submitted to FDA, or both.
PWC's data show a sustained improvement in the number of first-cycle approvals granted to "standard" NDAs and BLAs since 2008. In 2008, standard drugs had about a four-in-10 chance of being approved during their first review cycle (i.e. FDA didn't ask the manufacturer for new data, new clinical studies or outright reject the drug on safety grounds). In comparison, by 2012 drugs reviewed under a standard process had almost a six-in-10 chance of being approved.
Priority review drugs had substantial, though inconsistent, gains. In 2008, drugs subject to priority review were approved during the first cycle in 56% of cases. In 2011, a whopping 91% of such drugs were approved during their first review cycle. By 2012, that number had dipped slightly to 81%.
View of the FDA
Those improvements have resulted in an industry that now appears to be more appreciative of FDA than in years past. One hundred executives polled by PWC said they believed FDA was providing more actionable feedback (76%), better and more frequent feedback (78%), and 70% of respondents said they thought FDA was offering "more applicable guidance, rules and regulations."
Another interesting piece of feedback from the report: Many companies find FDA's guidance documents to be quite helpful. Sixty-eight percent of executive respondents from large companies found the documents to be helpful, while 82% of respondents from smaller companies found them to be helpful.
More than 40% of executive respondents also said they would support FDA "evaluating a drug based on both clinical and economic effectiveness."
Patients seemed to have a more negative view of the agency. Just 38% of consumers polled by PWC said they believed FDA incorporated their views into the review of new products.
The FDA and industry: A recipe for collaborating in the New Health Economy