First Person | Mark B. McClellan
Courtesy of FDA
Mark B. McClellan, the baby-faced, dual-degreed head of the Food and Drug Administration, is rarely the prince when he plays dress-up with his twin 4 1/2-year-old daughters. McClellan, the 40-year-old former Stanford economist and internist, is generally the ogre. Or the dinosaur.
He takes his servile status in stride. "Princes are not an integral part of these stories," says McClellan, who was weaned on Texas politics. "There are weddings, but they [rarely] involve a prince."
While his playroom influence may be minor, his impact on the FDA, since arriving there in November and taking charge of its $1.6 billion budget, has been anything but. His new, let's-play-ball-with-pharma strategy (just one of the changes the agency is orchestrating) has caught the media's attention. "The FDA has clearly come a long way in its transformation from quiet consumer protection agency to lightning rod for controversy," said the Financial Times in July. ".... [McClellan] is not interested in the status quo."
Streamlining the drug-approval process, says McClellan, is vital. "I am looking for quicker resolution: yes or no. More certainty is less cost."
Some accused you of lobbying against the Gutknecht- Emerson Bill, which would allow the importation of cheaper prescription medicines. Is that the case?
The FDA doesn't lobby. A key part of our mission is to make sure that Congress has the facts.... Our contacts with members on the Hill on that legislation [were] with the appropriation committee a nd authorizing oversight committee. Both committees had held hearings. It is entirely appropriate for us to provide information.
You want to shorten drug-approval processes. What part do you want to leave out?
[Today] the process is more complex and potentially tailored to individual types of diseases. Most product developers are testing compounds on glass slides, doing micro-array work, seeing if there is impact on gene expression. The problem is, they are not developing a whole lot of knowledge. It often raises additional questions about product benefits and risks. We still have to do the full scope of clinical development.... I don't like these two trends, rising health care costs and uncertainty of drug development. The FDA is trying to help improve the links between what is seen in the lab, in terms of gene expression, and consequences of safety.
It sounds like you want the FDA involved with the pharmaceutical researchers early on in the research process. Why is that?
[It] can help in reducing costs and time.... By having early contacts and earlier feedback on applications, even ideas still in development... we can determine if the compound is safe and effective or not.
Velcade, the proteasome inhibitor approved for terminally ill patients with multiple myeloma, was approved in a few months, after a successful Phase II trial. Why?
We want to get drugs out for people who need them ... Velcade is being marketed, it was approved with additional steps [in conjunction with the National Institutes of Health] for postmarket studies.... This increased effort on postmarket efforts is something I am strongly committed to.
What's a favorite thing to do?
I enjoy [spending time] with the kids. I grew up with three brothers; this is all new and different for me.
What music do you listen to?
Driving between meetings and things, I like jazz, [but] I've [become] quite familiar lately with Sesame Street and the Wiggles.
What do you enjoy more--medicine or economics?
I enjoy both of them. At Stanford, we got to thinking about a lot of big issues [that made a] significant impact on the health of the public.... And once a week, I got to take care of patients, and [make an] impact on their lives. Now, it's a direct mixture of both. We are thinking of big policy issues, but making material impacts in the short and long term.
What's stressful for you?
Balancing all concerns. The day-to-day is not particularly stressful. The days are too short; I wish I had more time to spend with my kids and my family.
Do you send E-mails at 11 p.m. to staff?
E-mail is good for agencies like the FDA, which is spread out all over the country .... It's not a bad way to do things.
What was your childhood like?
I tried to organize mock elections for kindergarten class. One of my earliest memories is licking envelopes for political campaigns. My mother was county chairman. My parents divorced when I was 10. My mother [Carole Keeton Strayhorn] was mayor of Austin ... The notion of having lots of things going on [at one time] is something I was conditioned on. My one brother works for the attorney general's office in Texas. [Another brother, Scott, is the White House spokesman; his mother is now the Texas comptroller.]
Is politics encoded in the McClellan DNA?
It's definitely a family tradition. My family has a lot of strong women in it. My grandmother moved from Tennessee to East Texas .... They grew up as cotton farmers ... my grandfather was dean of the UT law school. [My grandmother said,] 'It's not the dollars you make, it's the difference you make.'