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Thursday, May 20, 2010

FDA Proposes Far-Reaching Transparency Initiative; Public Peek at Industry R&D Failures

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The Food and Drug Administration's transparency task headed by deputy commissioner Joshua Sharfstein today proposed opening the drug and device industry's research and development process to an unprecedented level of public scrutiny. The agency is proposing to publicly disclose the existence of:

* Individual investigational new drug applications (which are submitted by company and academic researcher before they are allowed to try an experimental drug or device in human subjects);
* The withdrawal or termination of INDAs and the reasons for those actions;
* Immediate public posting of all new applications for drugs, biologics, generics, new devices or similar devices (submitted for agency review when efficacy trials are completed);
* The withdrawal or rejection of new applications (approvals have always been announced);
* The full text of response letters for new drug, device and biologic applications, whether or not approved by the agency; and
* Whether an application received an orphan product designation (needed by 300,000 patients or less), and if it did, whether it was withdrawn or abandoned for safety reasons and whether, if approved, it would represent a significant therapeutic breakthrough for a rare disease.

While obviously a boon to patient advocacy groups, this information will also be of great interest to company rivals, Wall Street analysts, industry consultants and academic and independent observers who closely monitor R&D activities. The only current source of specific industry R&D activities is a self-reporting database contained on the Pharmaceutical Research and Manufacturers Association website and Securities and Exchange Commission filings, which often do not report R&D activities until they are nearing the final stages of the process and are most relevant to stockholders.

In a perspective published today by the New England Journal of Medicine, Sharfstein and agency attorney Afia K. Asamoah noted "not all these proposals will necessarily be implemented. Some may require changes in law or regulation, and some may require substantial amounts of resources." The agency will be taking public comments until July 20.

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