Does Leadership Count at the FDA?

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Let's go right to the top of the matter as we tackle a final question about the rate at which the FDA has been approving new drugs in recent years. Does it matter who is leading the regulatory agency?

Some investors have speculated that the FDA leader is as important as the R&D budgets of the big pharmas when it comes to the number of drugs approved. Since 2001, there have been five FDA commissioners or acting commissioners at the helm.

Using the data I collected for new molecular entities, new salts, biologics, and new vaccines approved since 2000, I sorted my list of these truly new drug approvals by FDA commissioner, to see if any patterns or noticeable data points emerged.

Follow the leader ... or not?
Whenever Congress appoints a new FDA commissioner or someone new steps in as acting head of the agency, investors opine about whether the new FDA head's background will affect the number of drugs making it to market.

For example, when Andrew von Eschenbach became acting head of the FDA in 2005, many investors speculated that his background as the leader of the National Cancer Institute would usher in an era where oncology-directed compounds like Amgen's (Nasdaq: AMGN) Vectibix, Onyx Pharmaceuticals' (Nasdaq: ONXX) Nexavar, and Bristol-Myers Squibb's (NYSE: BMY) Sprycel would have an easier time at the FDA. [Von Eschenbach was sworn in as commissioner in December 2006.]

But what do the numbers show us?

Not counting approvals of follow-on drugs like Flamel Technologies' (Nasdaq: FLML) extended-release version of GlaxoSmithKline's Coreg, or combination drugs of already approved compounds like Pfizer's (NYSE: PFE) Caduet, what follows is a list of the number of truly new drugs approved under each head of the FDA since 2001.

CBER stands for the Center for Biologics Evaluation and Research and CDER is the Center for Drug Evaluation and Research. Most new vaccines, like Merck's (NYSE: MRK) HPV vaccine, Gardasil, and some biologics are approved in CBER, whereas the majority of new drugs are approved in CDER.

Comm. or Acting Comm.	Date of Service	CBER Drug Approvals*	CDER Drug Approvals*	Total Approvals	Months as Head of FDA	Average Monthly Approvals
Andrew von Eschenbach	9/05 to Present**	14	43	57	24	2.38
Lester Crawford	3/04 to 9/05	9	38	47	18	2.61
Mark McClellan	11/02 to 3/04	11	43	54	17	3.18
Lester Crawford	2/02 to 11/02	1	12	13	9	1.44
Bernard Schwetz	1/01 to 2/02	3	32	35	13	2.69
both Crawford terms combined		10	50	60	27	2.22

* At the start of 2004 some drug approval responsibilities transferred from CBER to CDER.
** Through end of September 2007.
***Drug approvals counted only for exact dates of service (i.e. Eschenbach started on 9/26/05 so only approvals after Sept. 26, rather than for the whole month, were attributed to him).

Von Eschenbach and Lester Crawford have by far the most months logged as head of the FDA, but neither of their terms saw the average monthly approvals go up, as some investors might expect to occur as an FDA commissioner gets settled into his new role. Of course, lots of other factors, like drugmaker research and development productivity and the political climate, affect the number of drug approvals.

Final thoughts
It's also important to remember that the FDA commissioner isn't the only leader at the agency who matters. The heads of CBER, CDER, and other divisions of the agency probably have a more direct impact on the number of drugs that get approved through their divisions than the FDA commissioner does.

As my data above shows, it seems that the FDA commissioner doesn't have much of a visible numerical effect on the approval rate of new drugs as a whole, even if he may impact the approval of individual drugs like Barr Pharmaceuticals' (NYSE: BRL) Plan-B.

Read the rest of the Foolish FDA series:

• Is the FDA Still Approving New Drugs?
• Scrutinizing FDA Drug Approvals
• Welcome to the New Era of FDA Regulation
• Drugmakers Spinning Their Wheels

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