FDA speeds up drug, device approvals

FDA's process for approving drugs and devices is speeding up, according to a PricewaterhouseCoopers (PwC) Health Research Institute report.

“Increased pressures for speedy access to breakthrough drugs and medical devices, and a focus on value in addition to medical benefit, are driving these changes. Those changes will likely put pressure on the FDA to consider changes as well,” PwC said in a statement about the report, “The FDA and industry: a recipe for collaborating in the New Health Economy”.

Novel new drugs approved in 2014

FDA approved premarket approval applications (PMAs) in half the time (7 months) in 2012 than it did just 3 years earlier in 2009 (14 months), according to the report. In addition, 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, the Regulatory Affairs Professional Society reported.

FDA drug approvals-January 2015

Plus, the agency approved new drugs subject to priority review in 11 months on average in 2008. However, in 2011 and 2012, the number dropped to 6 months-the target set by the Prescription Drug User Fee Act (PDUFA), according to RAPS.

In addition, 78% of drug and device manufacturing executives surveyed by PwC said that FDA has improved the quality and frequency of its communication. However, 71% still believe FDA can accelerate approval programs by balancing swifter approval with increased post-market surveillance.

Specialty drugs: A good value despite high costs

“While recognizing the FDA’s investments to improve its relationships with manufacturers and speed drug and device delivery, manufacturers still want greater flexibility in product development and review,” said Mike Swanick, global pharmaceuticals and life sciences leader for PwC.

For their part, medical and drug device companies are focusing on cost-effectiveness as well as medical benefit. Forty-three percent of survey respondents said they are willing to have their products judged based on both clinical and economic value, compared to just 14% in 2010.

Meanwhile, the healthcare consumers surveyed said they would like input into developing therapies.  Relatively few (39%) believe FDA incorporates their views in the agency’s review process, and only 38% say that drug and device manufacturers adequately consider their views.