Dr. Janet Woodcock - FDA, CDER

FDA vet pushes industry to focus on innovation

Name: Dr. Janet Woodcock
Title: Director, FDA's Center for Drug Evaluation and Research (CDER)

Dr. Janet Woodcock spearheaded the FDA's CDER through a banner year in 2012, with a stellar 39 new drug approvals--the most since 1996. Industry chiefs from around the world have applauded the agency for the scientific approach to drug reviews that Woodcock and her center's employees have striven to take.

Under Woodcock's leadership, the agency has become more sure footed in its approach to new molecular entities. Groups within CDER took swifter action on most new drugs last year than the agency's counterparts in Europe and elsewhere. Those moves brought the first FDA approval of a treatment that targets an underlying cause of cystic fibrosis, Vertex's ($VRTX) Kalydeco, as well as other initial agency nods for a cord-blood-based treatment and therapies for the most common form of skin cancer. 

Particularly with new cancer drugs, the agency has zeroed in on molecular and clinical data that supply evidence of efficacy at an early stage, helping Woodcock's crew green-light treatments more quickly. It's also taken a more rational approach to weighing risks and benefits of drugs, with the agency approving two new obesity drug products last year, including Vivus' ($VVUS) Qsymia and Arena Pharmaceuticals' ($ARNA) Belviq, after more than a decade without any such meds approved in the U.S.

The general tenor of decisions and stances from CDER can have a direct impact on how pharma invests in research, and the approvals of the obesity treatments and other new meds have inspired confidence in how the agency is handling complicated reviews.

"The FDA has really shifted back to a very disciplined scientific approach to drug approvals," Novartis ($NVS) CEO Joe Jimenez told Reuters during the World Economic Forum in Davos, Switzerland, last month, "so we are starting to see more drug approvals come through."

Woodcock, who joined the agency in 1986, has helped establish CDER as the team to beat around the world for new drug approvals and other initiatives that focus on streamlining the regulatory path meds take before reaching patients. According to an agency report in December, the U.S. regulator acted first on new drug nods in about 75% of cases in 2012.

Last year, Woodcock also worked on laying the foundation for continued progress at the agency. With PDUFA reauthorized for 5 more years in June, she elevated the group that handles generic drug reviews to "super" status, and the office is expected to get an influx of resources this year to evaluate inexpensive copycat meds efficiently.

From her high post, Woodcock has also applauded new initiatives among industry and nonprofit groups to remove inefficient practices from drug development and to start up new models to advance studies for new treatments. With her endorsements, the agency has signaled its willingness to work on changing the ways drugs are researched and developed, which is badly needed throughout the industry to improve the flow of new meds to patients who need them.

No one in the biopharma industry will accuse the FDA of being perfect, but it's improved significantly.

-- Ryan McBride (email | Twitter)

Dr. Janet Woodcock - FDA, CDER