Mixed and Slower
“If you’re in cancer or infectious diseases or if you’ve got an orphan drug, the agency is using pretty much all the tools at its disposal to move along those reviews and approvals. But in other areas—diabetes, endocrinology, CMS—the performance is much more mixed and slower,” David L. Gollaher, Ph.D., president and CEO of the California Healthcare Institute (CHI), told GEN.
CHI, which represents California’s biomedical industry, joined the Boston Consulting Group (BCG) in May to issue a report concluding that despite FDA efforts to shorten reviews, the agency took longer to approve drugs for diseases and conditions posing serious public health threats—including cardiovascular disease, obesity, and diabetes—than for cancer, hepatitis C, lupus, pneumonia, and orphan diseases.
During 2012, FDA approved three cardiovascular drugs, and one diabetes drug—Eli Lilly’s Jentadueto (linagliptin plus metformin hydrochloride) for type II diabetes. But the agency also okayed the first two weight loss drugs in more than a decade, Vivus’ Qsymia (phentermine and topiramate extended-release) and Belviq (lorcaserin hydrochloride), made by Arena Pharmaceuticals and distributed by Japan’s Eisai.
“Taken as a whole, the FDA has remained committed to getting important new products to the marketplace,” Dr. Kaitin said.
A key to that commitment, he said, was the series of PDUFA laws under which drug developers are charged “user fees” through which FDA funds new drug reviews. Every five years since 1992, PDUFA laws have sought to balance industry interests with FDA’s traditional interests in ensuring drug safety and efficacy.
“These issues that tended to fester over a long time, they really can’t anymore,” Dr. Kaitin said. “I don’t see a return the way we had in the past, where we went from 1962 to 1992 with an overly cautious, difficult to deal with, often confrontational regulatory agency.”
PDUFA laws alone won’t ensure smoother sailing for drug developers. As FDA likes to say, it can’t approve applications that don’t exist. That puts the burden on industry to continue developing drug candidates capable of withstanding agency scrutiny. But as Barry I. Eisenstein, M.D., senior vp, scientific affairs with Cubist Pharmaceuticals, correctly noted to GEN last month, all therapeutic areas are struggling with a greater degree of difficulty in finding new leads for breakthrough therapeutics.
“The modern genomic era, which 15 years ago we thought was going to allow for breakthroughs in a rapid way, has still not yet evolved to the point where it’s demonstrating that degree of proficiency in getting new leads,” Dr. Eisenstein said.
Until that improves, FDA is unlikely to see the sustained increase in new applications needed so it can approve more new drugs in coming years.