Companies hoping to prevent public disclosure of some drug development milestones will have to marshal legal arguments following a recommendation by FDA's Transparency Task Force that the agency should disclose when applications are submitted and withdrawn.

The task force issued 21 draft proposals on May 19 intended to increase the amount of agency information available and help the public better understand agency decisions. FDA said in the report it is possible some of the recommendations will not be implemented.

Joshua Sharfstein, FDA principal deputy commissioner and task force chair, said this summer staff will begin determining next steps. Comments on the proposals will be accepted for 60 days.

"This report, we really focused on the policy issues, what would be the right thing to do," Sharfstein said during a conference call. "It is definitely true that some of these are going to require some legal changes, but we're not at the point, nor have we done the analysis, that we could tell you which one requires what particular legal change."

The task force recommendations are the second phase of the FDA transparency initiative. Phase one included providing more information to the public about FDA operations. Phase two will include what types of information the agency can disclose and phase three will look at how FDA can be more open with industry about its processes (Also see "FDA Transparency Initiative Sees No Clear Path To Releasing Documents, Woodcock Indicates" - Pink Sheet, 26 April, 2010.).

The agency launched the FDA Track website in April as part of the transparency program to let the public follow agency goals for more than 300 activities, including approvals of ANDA and Risk Evaluation and Mitigation Strategies (Also see "FDA Launches New System To Track Performances of Its Offices" - Pink Sheet, 7 April, 2010.).

Applications, Withdrawals Should Be Released

Among the more significant proposals from the task force were disclosing when new drug applications, premarket approval applications, abbreviated new drug applications and biologics licensing applications are submitted, along with the sponsor name and proposed indication.

The group said public availability of the information may reduce confusion about product development, but still would not allow a competitor to copy a product formulation.

"The potential availability of a new product on the market is not the only basis on which products compete," the task force said in the report. "For example, improved effectiveness of the product, fewer side effects, and easier use by the patient are among the factors that differentiate products on the market."

The task force also wants the agency to disclose when those applications are withdrawn or abandoned by the sponsor and when complete response and refuse-to-file letters are issued.

The group concluded FDA should explain publically its reasons for not filing an application and not approving a medical product. Aside from improving agency credibility, the public release also could help health care professionals and investors make better decisions.

"Disclosure of when and why an application is withdrawn or abandoned by the sponsor for a significant safety reason should allow researchers studying the same molecule or device...to use that information to protect patients from the identified and potential risks," the task force said in the report.

Many of the proposed disclosure policies already are in use by the European Medicines Agency. The task force said given the global nature of the pharmaceutical industry, most companies are subject to European rules already, which would mitigate potential competitive problems posed by increased FDA disclosure.

Sharfstein said the task force did not rely on the European rules when writing its proposals. While the recommendations are similar, the proposals are not exactly the same as the EMA disclosure policy, he said.

"I think it was helpful to our kind of assessing what is a reasonable expectation of companies as sort of the ground has shifted around transparency, but I don't think that that was the core of the policy judgment," Sharfstein said.

Raw Clinical Trial Data Release Not Endorsed

The task force did not encourage full disclosure of all agency documents. It said letters responding to chemistry, manufacturing and controls supplements, ANDAs, ANADAs, or labeling supplements did not have to be disclosed because they primarily relate to manufacturing processes and labeling negotiations, which are mostly proprietary.

The group concluded releasing those documents would "provide little insight about the rationale underlying FDA's drug review process."

Task force members did recognize the importance of public availability of clinical trial data, but would not say the raw data should be released. The group instead said FDA should make summary safety and efficacy data available from investigational applications or pending marketing applications, if it is in the interest of public health.

But the group still appeared to err on the side of releasing the data. It said a blanket policy against releasing summary safety and efficacy data does not account for the public health benefits of disclosure. And in a description of trade secrets, given earlier in the report, it hinted the value of trial data may be greater in the public domain.

"The task force believes that trade secrets have limited value for public disclosure and that the value for public disclosure of other types of data, such as clinical trial results and adverse event reports, is significantly greater," the report stated.

Harlan Krumholz, a Yale University School of Medicine professor, called for all clinical trial data to be released during a congressional hearing on the safety of GlaxoSmithKline's diabetes drug Avandia , and also said the data should be reviewed independently (Also see "Avandia Aftershocks: Will FDA Drug Safety Review Structures Crumble?" - Pink Sheet, 3 May, 2010.).

A committee of stakeholders still should talk about appropriate circumstances for the release of the raw data, the task force recommended. Sharfstein said FDA is not the only player involved in the discussion.

"I think that what this report says is we're very interested in spurring those conversations," he said. "We think that all the different ... players should be brought together and talk about whether there are basic policies that make sense."

-Derrick Gingery (d.gingery@elsevier.com)

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