FDA Gets Investor Advice On Transparency At White House Gathering

FDA recently met with venture capitalists and drug industry leaders to discuss the agency's initiative to become more transparent. While such get-togethers are not unusual, the location of this one signaled how significant the topic is to FDA. Rather than meet at the agency's still-being-renovated headquarters in White Oak, participants gathered at the White House.

The White House Office of Science and Technology Policy hosted the meeting on Aug. 11. FDA Principal Deputy Commissioner Joshua Sharfstein, United States Chief Technology Officer Aneesh Chopra and members of the White House Open Government Initiative met with a dozen people.

The participants included representatives of Warburg Pincus, the National Venture Capital Association, New Enterprise Associates and Oxford Bioscience Partners. Members of three drug companies were also in attendance: Barry Eisenstien, senior VP, scientific affairs at Cubist Pharmaceuticals; Michael Doherty of Genentech; and John Griffin, chief scientific officer at Numerate.

They offered advice on how the agency could better explain its processes, what information would be helpful for FDA to provide to sponsors who submit product applications, and how transparent processes can foster product development and innovation.

Their input will be forwarded to Commissioner Margaret Hamburg. The agency announced in June that it had created an internal Transparency Task Force to evaluate how to make the agency's decision-making process more accessible to the public (¹ (Also see "Sharfstein Heads FDA Transparency Task Force" - Pink Sheet, 8 Jun, 2009.)).

As part of this initiative, the agency established the ² FDA Transparency Blog to discuss ways it could provide information to the public. FDA also solicited comments from the public on improving transparency, and it received 900 comments by the time the docket closed on Aug. 7; the docket has now been reopened until Nov. 6 to accept additional comments.

FDA Highlights Advice From Oregon DoJ

The agency is posting select comments on its blog. One of the submissions it highlighted was a ³ recommendation by David Hart, senior assistant attorney general in the Oregon Department of Justice, for FDA to make public "non-approvable" letters explaining why an indication was not approved, the relevant analysis by the agency and all clinical trials that were the basis for FDA's non-approval.

Hart has led several multi-state investigations of drug companies for alleged health care fraud. In one of these cases, the states claimed that Pfizer promoted Bextra (valdecoxib) for off-label indications after FDA refused to approve the drug for such uses.

"In our complaint we alleged, among other things, that after FDA refused to approve an application to market Bextra for acute and perioperative pain, the drug company went ahead and promoted these indications by distributing hundreds of thousands of copies of a positive study from the NDA without discussing or presenting a negative study from the NDA that was the basis for FDA's refusal to approve," Hart stated.

"Had FDA made public the non-approval letter, the analysis by the FDA medical officer assigned to review the NDA, and the relevant clinical trials, it would have been more difficult, if not impossible, to promote the drug off-label for these indications."

Last year Pfizer agreed to pay the states $60 million to resolve a five-year investigation of its promotion of Bextra and Celebrex (celecoxib) (⁴ (Also see "Pfizer Forks Over $894 Million To Settle Celebrex/Bextra Litigation" - Pink Sheet, 17 Oct, 2008.)). Hart also won a $58 million settlement with Merck over its promotion of Vioxx (rofecoxib) and a $62 million settlement with Lilly to resolve allegations the company engaged in off-label marketing and failed to disclose potential side effects of Zyprexa (olanzapine).

FDA now uses the term "complete response" to describe what had been "approvable" and "non-approvable" letters, but there's some indication the agency would like to see a change permitting the disclosures that Hart is advocating, since the information in the letters would help clarify FDA's approval standards (⁵ (Also see "FDA To Investors: Ask For The Letter" - Pink Sheet, 19 Aug, 2008.)). FDA insists that it cannot release the letters because of prohibitions on disclosing trade secrets, suggesting that transparency of the type that Hart is advocating would require a statutory change.

- Brenda Sandburg ( ⁶ [email protected] )