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Inside Health Policy – FDA Counters Concerns About Decreased Drug Approvals With Innovation Analysis

Inside Health Policy – FDA Counters Concerns About Decreased Drug Approvals With Innovation Analysis


Approvals of first-in-class drugs have remained consistent throughout recent decades, according to an FDA analysis of innovative drug approvals that the agency hopes will influence future policies geared toward increasing drug development. FDA defined three categories of new molecular entity approvals in developing metrics that go beyond using the annual number of approvals to gauge innovation — a tool that potentially could be used to evaluate the effectiveness of some innovation-geared provisions of the FDA Safety and Innovation Act, the agency said.

FDA analyzed 645 NMEs approved between 1987 and 2011, finding that 203 were first-in-class drugs — one of three innovation categories the agency defined in the study, which was published this month in Health Affairs. The other categories were: advance-in-class drugs — defined as drugs that were not first in their class, but received a priority review designation — and addition-to-class drugs, which function similarly to other drugs in their class.

Mike Lanthier, an operations research analyst in FDA’s Office of Planning, who co-wrote the study with FDA’s top drug official and agency economists, said FDA sought to move beyond measuring drug innovation based on the number of NME approvals each year.

“So much has been said and written about the supposed innovation gap in drug discovery that it’s generally been accepted as truth and a topic of deep angst for the pharmaceutical industry,” he said in an agency blog post. “And yet, if you take a hard look at the data, as we did, you’ll find it isn’t true. The fact is, the way data is collected has been masking some important facts.”

FDA could use the study’s analysis methods to evaluate whether innovation-geared provisions in FDASIA, such as the breakthrough pathway, accelerated approval expansion and antibiotic development incentives, provide medically meaningful innovation, according to the report.

“A number of initiatives were launched during 2002–11 to foster innovation in drug development,” according to the study. “More recent statutory and regulatory policy efforts are reinforcing this push. Thus, our observations may be of interest to policy makers as a baseline and method against which the success of these initiatives can be measured.”

Innovation was a constant thread in lawmaker discussions around FDASIA. Some pressed for provisions requiring FDA to include innovation in the agency’s mission statement, although they were not ultimately included in the law.

In the study, FDA analyzed approval trends, including those before and after approvals peaked in 1996 and 1997 at 49 and 40, respectively. Outside those years, approvals remained around 20 to 30 each year.

FDA said addition-to-class approvals, also known as “me too” drugs, drove trends over the years, including the spike in the mid 1990s. Meanwhile, first-in-class approvals remained steady, with an average of about eight new drugs in that category per year, except for an unexplained drop in 2008 and 2009.

FDA found 299 addition-to-class drugs, which represented 135 drug class categories. However, 60 percent of addition-to-class approvals were concentrated to 35 drug classes. Among those classes were cephalosporin and fluoroquinolone antibiotics, blood pressure treatments and treatments for other chronic conditions.

Advance-in-class drugs accounted for 143 approvals of the 645 studied approvals. The share of drugs in the category has fallen in recent years, but there has been an increase in first-in-class approvals in the past decade, according to the analysis.

FDA noted some limitations to the analysis, saying that determining which drugs are first in class is subjective, although the agency used FDA-established terms and categories to apply the classification methodology. Further, companies can innovate incrementally through new formulations or new uses for existing drugs, although the study did not capture these advances.…