BY Charlotte Schubert

An initiative to increase transparency at the US Food and Drug Administration (FDA) moved forward on 6 January with the release of a report detailing steps the agency says it is undertaking to make its inner workings more evident to the drug industry.

The report, FDA Transparency Initiative: Improving Transparency to Regulated Industry, includes 19 so-called ‘action items’ for implementation this year, ranging from posting presentations by agency employeesonline to responding faster to questions from industry. The document also lists five draft proposals—now up for public comment—to further improve transparency. Both industry and advocacy groups greeted the new report positively. “It’s a good first step,” says Jeffrey Francer, assistant general counsel at the Washington, DC–based Pharmaceutical Research and Manufacturers of America (PhRMA).

Jeff Allen, director of Friends of Cancer Research, an Arlington, Virginia–based group that advocates for improvements in drug regulation, who described the report as “winwin” for the FDA and industry, applauded the proposal for the FDA to post timelines of when it will aim to release new ‘guidance documents’ that outline policies relating to clinical trials and drug development. Drug companies, particularly smaller ones, currently have only a vague idea—often based on rumor—of when the FDA plans to release new guidelines, says Allen.

Increasing transparency in this area, says Allen, "will make things a little more clear to industry as they prepare their submissions and design their studies."  Among the other pledges that should please industry, the report stated that the FDA "is setting the expectation of responding to email questions about the regulatory process within five days." 

Francer says the FDA took on many of the changes suggested by industry, but not others—such as an industry proposal calling for a mandatory meeting with industry halfway through the drug application process. Such a meeting could, for instance, help companies learn early that they might need to prepare additional data, thereby avoiding a lengthy second review process.

If there was a hiccup in the transparency project, it came one day after the report’s release. On 7 January, the FDA lost one of the initiative’s biggest champions when Deputy Commissioner Joshua Sharfstein, who chaired the FDA committee in charge of the initiative, left the agency to lead the state department of health in Maryland. John Taylor, the top lawyer in FDA commissioner Margaret Hamburg’s office, stepped in as Sharfstein’s temporary replacement for two months, after which a permanent replacement will be appointed.

Despite Sharfstein’s departure, transparency efforts at the FDA will not lose momentum, according to Afia Asamoah, the FDA official in charge of implementing the initiative. She notes that the initiative is “kind of a brainchild” of Hamburg’s and has broad support throughout the agency. “Commissioner Hamburg is committed to insuring that the transparency initiative continues,” Asamoah says.

Asamoah adds that the agency is on track to finalize a separate set of proposals it released last year to increase transparency to the public. Some of these proposals would increase public access to industry information, such as whether a drug application has been rejected or put on hold.