I’ve read several press releases over the past couple of week announcing and interpreting the significance of FDA drug approvals over the past year. Most give you the impression that the results are encouraging and suggest Pharma R & D is in recovery mode. Traditional PhRMA bragging points of spending more than $60 billion per year on R & D, the thousands of compounds in development, and hundreds of innovative new medicines approved over the past couple of decades are, however, somewhat tempered by the reality of the recently reported drug approvals, especially for Big Pharma. I don’t mean to downplay the challenges of drug discovery and development but it’s important to look beyond the total number of approvals to determine what that number really represents.
A closer look at the list of 35 FDA approved drugs for fiscal 2012 (October 1, 2011 to September 30, 2012) reveals rather dismal R & D productivity and lack of innovation that has haunted Big Pharma for the past several decades.
First let’s put 35 new drug approvals into context. These new drug approvals were the results of decades of hundreds of billions of dollars invested in research being done at or by more than a thousand Pharma and Biotech companies as well as thousands of government and university laboratories. Pharma reminds us frequently of the hundreds of compounds in development for different diseases. Yet, only 35 new products in 2012 … not very impressive. Also interesting to note is that there are 31 different sponsors for the 35 New Drugs Approved. So out of more than 1000 pharma and biotech companies out there, only 31 entities got a drug to the approval list.
The list better reflects the importance of smaller research organizations in discovering and developing new drugs. Depending on how you define Big Pharma (e.g., are Gilead, Forest Labs, and Astellas Pharma considered Big Pharma?), you may end up with slightly different numbers but Genentech/Roche, Bayer, and Sanofi contributed 4 of the 12 “Priority Drug Approvals”. More to the point, of the 35 drugs listed, if we’re generous in a definition of Big Pharma, only 13 of 35 drug approvals were “sponsored by” Big Pharma.
What’s more disheartening is the evidence of diminishing drug discovery at Big Pharma. While celebrating the 35 approvals, a little investigating reveals that the overwhelming number of approved products were not discovered by or at Big Pharma. You have to dig a little but even where Big Pharma is listed as the sponsor, many of the approved compounds were licensed in or acquired from collaborative work with smaller biotech companies. Again, being generous in how you might define Big Pharma, only 6 or 7 products on the list were actually discovered at a Big Pharma. And in this number, two were discovered by Genentech (acquired by Roche), one is an analog of a previously approved biotech product, one is a combination vaccine, and another is a combination of previously approved products. So much for Big Pharma innovative “discovery research.”
So while the total number may be reassuring in the context of previously disappointing years of smaller numbers of drug approvals, a closer look reveals that drug discovery and drug development are no longer being driven by Big Pharma. More importantly, despite the investments being made, new drug discoveries remain elusive and approvals are rare regardless of who is doing the work.