FDA’s Crawford Open To Discussing Independent Drug Safety Office

FDA Acting Commissioner Lester Crawford is willing to consider making the Office of Drug Safety formally independent from drug review activities if he is confirmed as the agency's permanent leader.

"An independent office is something that I'm certainly open to discuss," Crawford told the Senate Health Committee during a March 17 confirmation hearing. The panel is tentatively scheduled to vote on Crawford's nomination April 13, after lawmakers return from the Easter recess.

In response to committee members' questions on the drug safety issue, Crawford acknowledged the value of independence at ODS. He also said it is his responsibility to make sure the drug safety office has the appropriate level of autonomy and authority.

"It is up, I think, to me to make sure they [ODS] act independently, that they are not intimidated, that the conclusions of the ODS are given the attention that they should be," Crawford said.

He stressed his own role in overseeing the office, stating that "the strength of ODS is very important, and they need to be carefully monitored by me and other leadership at FDA to make sure they are truly experts in drug epidemiology."

Crawford cast drug safety as the agency's top priority. "Nothing is more important at FDA right now than this drug safety issue, and I will continue to monitor it," he declared.

"We need to do more work, though, on the culture of FDA," Crawford said, pointing to a need for greater transparency because the agency's "decision-making is not understood by the public."

However, the acting commissioner maintained that FDA's reputation has not been "tarnished" by recent drug safety controversy. "Checking with our international colleagues and also checking with various polls that have been done, it looks like the American people have full confidence in FDA," he said.

Overall, Crawford echoed the variety of public positions taken by other FDA representatives in recent months: he appeared receptive to lawmakers' calls for a more independent drug safety review function while also standing by the agency's current organization (¹ , p. 7).

"I think it's possible, and I think it's being done, to have ODS serve in a place on the organizational chart and also physically so that they are not subsumed by the primary drug reviewers and others in the center for drugs," he said. "I believe they are operating independently."

He reported that the agency plans to make an announcement regarding a permanent director for ODS "within the next few days"; FDA Emergency Preparedness Officer Ralph Lillie currently is the office's acting head (² (Also see "FDA Office Of Drug Safety Acting Director Is Ralph Lillie" - Pink Sheet, 31 Jan, 2005.), p. 6).

That position will fall within the Center for Drug Evaluation & Research, Crawford said, rather than report directly to the commissioner.

Sen. Barbara Mikulski (D-Md.) insisted that the ODS director should be separate from CDER, to which Crawford said, "if the person reported to me, which is something that we can consider, I would essentially have to be the person who did their job evaluations."

Mikulski was one of several Democratic committee members to renew their support for an independent safety review function at FDA during the confirmation hearing.

Sen. Christopher Dodd (D-Conn.) noted that he and Finance Committee Chairman Charles Grassley (R-Iowa) are preparing to introduce legislation to create an independent safety office within the agency (³ , p. 4).

Overall, however, Democrats' most pointed questions for Crawford concerned FDA's handling of a proposed Rx-to-OTC switch for Barr's Plan B emergency contraceptive.

Committee members will have the opportunity to pose other inquiries to Crawford in writing; the nominee is due to provide his responses before the Senate reconvenes in April.

Crawford faces a thorough array of questions from Grassley; Senate Health Committee Chairman Mike Enzi agreed to proffer a lengthy list to the nominee on Grassley's behalf (see ⁴ (Also see "Drug Safety User Fees Explored By Sen. Grassley In Questions For Crawford" - Pink Sheet, 21 Mar, 2005.)).