Lately, the FDA's new drug approval process has seemed to adopt stricter, more safety-conscious measures. In that light, the agency's surely approving fewer new drugs, right? Apparently not.
For all the whining and blustering I've done about the current state of affairs at the FDA, new drug approvals from the agency's two branches that approve drugs, biologics, and vaccines were up year over year in the first three months of 2008.
Perceptions and reality
When I count new drug approvals, I'm reviewing new molecular entities, new vaccines, and new biologics approved by the FDA for use as therapeutic drugs in humans. I do not count newly approved combination therapies, generic drugs, or other types of new formulations. Of the compounds approved in 2008, four were from the Center for Drug Evaluation and Research (CDER) and three from the Center for Biologics Evaluation and Research (CBER), compared to four approvals from CDER and one from CBER in 2007.
In the first quarter of 2008, the FDA approved seven molecular entities:
- Cephalon's Treanda (leukemia)
Pristiq (depression) and Xyntha (hemophilia) (NYSE: WYE)
Artiss (a fibrin skin graft sealant) (NYSE: BAX)
Recothrom (surgical bleeding) (Nasdaq: ZGEN)
Arcalyst (various autoinflammatory conditions) (Nasdaq: REGN)
Johnson & Johnson's
Intelence (HIV) (NYSE: JNJ)
In Q1 2007, only five won approval:
- Shire's Vyvanse (ADHD)
Soliris (rare blood disorder) (Nasdaq: ALXN)
- Novartis' Tekturna (hypertension)
Tykerb (breast cancer) (NYSE: GSK)
- Baxter's Ceprotin (coagulation disorder)
Functionally, new drugs like Wyeth's Pristiq may not be very different from other already approved drugs on the market. (Compare the molecular structure of Pristiq with Wyeth's older Effexor XR compound, shortly to face generic competition.)
What about the bigger picture?
When looking at the total number of approvals, including reformulations of existing drugs, new combination therapies, new indications for existing drugs, and the over-the-counter sales approvals of drugs such as GlaxoSmithKline's Alli, 18 new approvals in Q1 2008 still topped Q1 2007's 13.
This broader definition of new drug approvals is less meaningful; drugmakers won't be able indefinitely to grow their top and bottom lines off reformulations or new indications for existing drugs. Eventually, an existing drug's generic countdown clock will strike midnight, and the patent and exclusivity protections for new indications or reformulations won't compare to those of a truly new molecular entity.
But still, the number of new drug approvals at the FDA is up across the board compared to 2007, even if it doesn't say anything about drugmakers' approval success rates.
Can drugmakers party like it's 2003 again?
Unfortunately, the number of approvals alone isn't a good indication of the FDA's regulatory stance on new approvals in general, or whether the process is getting easier or harder. A year-over-year change in the number of approvals could result from numerous factors, including increased drugmaker productivity in the face of a tougher FDA, or vice versa.
Indeed, 2007 was an exceptionally low year for new drug approvals this century. The average number of new molecular entities, vaccines, and biologics approved annually from 2000 to 2006 exceeded 31, but 2007 saw only 26 new approvals, by my calculations. Last year's number of approvals shouldn't be hard to beat.
Optimists can cheer that the FDA is on track (judging from Q1) for more new drug approvals this year than last. Meanwhile, pessimists can still bemoan that with a projected 28 approvals for the full year, 2008's looks like another below-average year.
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