Let's start with the good news.
In 2015, the FDA by its own
account approved 45 new drugs, the largest one-year tally since 1996, which
wrapped up with a record 53 regulatory OKs.
The new generational high,
easily lapping last year's list of 41 approvals, marks a new peak following a
surge by the R&D side of the business, which continues to recover from a
lengthy period of marked weakness. The FDA has helped, proving more than
willing to come through with faster approvals, particularly in oncology. And
the science around drug development has improved markedly as our understanding
of the genetic drivers of disease continues to make real progress.
But here's the catch: Higher
approval numbers don't necessarily translate into market-moving opportunities.
Throw another me-too drug into a pack of rivals and even the best sales force
can't do much with it, particularly if cheap generics dominate a disease. And
in the patent cliff environment that has persisted for several years now, it
takes blockbuster gains to make a big difference for the Big Pharma companies
that dominate the industry.
So who came out of 2015 a big
winner?