Friday, April 11, 2008

Tort(i) Law: A Safe Pick for FDA

Perhaps the most significant thing to say about FDA’s new chief scientist is that there isn’t much significant to say about him.

In Frank M. Torti, a cancer researcher and professor at Wake Forest University School of Medicine, Andrew von Eschenbach appears to have selected a safe second-in-command during what has been a tumultuous time for the agency—an academic who is well-respected in his field and without apparent ties to industry.

As we pointed out previously, by choosing a non-confrontational academic to fill the vacant deputy commissioner post, von Eschenbach leaves open the possibility that the official might stay on at FDA under a new Administration, thereby extending the commissioner’s legacy after he leaves the agency.

But is Torti long for the job? According to his Wake Forest colleagues, the FDA appointment is more of a sabbatical than a permanent gig. Jerry Garvin, MD, who was named interim director of the cancer center in Torti’s absence, told the Winston-Salem Journal that he expects him to return to Wake Forest within nine months to a year. “He’s coming back,” Garvin told the paper. “Thank goodness.”

Of course, von Eschenbach originally joined FDA on what was assumed to be a temporary basis back in 2005, so maybe Torti will learn to love the position.

A initial focus of Torti’s role will be overseeing an important and relatively uncontroversial human resources initiative: FDA’s two-year fellowship program designed to attract and retain quality regulatory and scientific professionals.

The FDA Fellowship Program is a priority for von Eschenbach before he leaves the agency; the commissioner has been talking it up in recent appearances in Washington. The program will help FDA hire the 700 new people needed to fully staff the agency while at the same time helping to create a constituency empathetic to FDA’s challenges.

Torti’s office will also “work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of the FDA’s regulatory structure,” the agency said.

It’s a vastly different set of responsibilities than those of Torti’s predecessor as deputy commissioner, Janet Woodcock. Before Woodcock became director of the Center for Drugs Evaluation & Research in March, the career official was all things to FDA: advocate for personalized medicine, champion of the Critical Path Initiative and chief implementer of the FDA Amendments Act.

In Torti, von Eschenbach has chosen a deputy commissioner with a background similar to his own. As the director of the Comprehensive Cancer Center at Wake Forest Medical Center, Torti specializes in genitourinary cancers. Von Eschenbach is himself oncologist and urologist, and is the former head of the University of Texas M.D. Anderson Cancer Center.

They also both have some experience in government service at the National Institutes of Health. Von Eschenbach served as head of the National Cancer Institute before joining FDA, while Torti is a member of NIH’s National Advisory Council for Complementary and Alternative Medicine.

So, OK. Maybe there are some things of significance to say about von Eschenbach’s newest hire. But unless we’re way off base here, it’s doubtful that the Torti Tenure will be too exciting for FDA—which is probably just what the doctor ordered.

No comments: