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FDA Shares Possible Transparency Rules

by Brendon Nafziger, DOTmed News Associate Editor | May 20, 2010
Transparency rules made clear
As part of its ongoing effort to bring more of its decision-making out into the sunlight, the U.S. Food and Drug Administration floated 21 draft proposals that would reveal more behind-the-scenes operations to the public.

The proposals, developed by the FDA's Transparency Task Force, came about after the agency reviewed around 1,500 public comments on the issue, the FDA said Wednesday.

The agency hopes the proposed changes, if adopted, would help the public better understand how the agency works while also protecting trade secrets and the privacy of patients.

"We really focused on the policy issues, what's the right balance between transparency and confidentiality," Dr. Joshua M. Sharfestein, principal deputy commissioner and chair of the Transparency Task Force, said in a call to reporters.

Under the proposals, the agency would be required to explain why a drug or device was declined, and whether it was rejected for safety reasons; notify the public about what devices were under investigation for FDA approval; and make it easier for the public to search for adverse event reports on agency websites.

Some of the changes could even spur new product development, the agency said. One change suggested by the FDA would allow the agency to say whether an "orphan" drug - one designed to treat a rare disease - whose application gets pulled by a company for business reasons, demonstrated any therapeutic benefit, thereby encouraging a possible competitor to carry on with the research.

The agency also hopes to use the transparency rules as a publicity campaign of sorts by highlighting its enforcement efforts. For instance, one proposal would require the FDA to share workplans more than five years old, starting with the workplan from financial year 2001. FDA's workplans describe how the agency allocates financial and human resources for enforcement. Generally, the FDA keeps this information under wraps to prevent the industry from gaming it to avoid scrutiny.

"Historical ORA Workplans provide the public with a better understanding of how FDA allocates limited resources to protect the public health and furthers the goal of the administration to increase the public's knowledge of FDA and its operations," the FDA said.

LEGAL QUESTIONS

The FDA acknowledged some of the proposals might require powers outside the scope of those given to the agency under current laws as well as additional manpower or finances.

"Some of the proposals require extensive resources to implement and some may require changes to regulations or legislation," Afia Asamoah, coordinator for the transparency initiative, wrote on the FDA transparency blog.