C3 Comments on Transparency at the FDA

An FDA task force has been formed to examine transparency at the Food and Drug Administration (FDA). “President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process,” said FDA Commissioner Margaret A. Hamburg, M.D. “I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making.”

One public meeting has been held, and a request for public comments has been posted. C3 provided comments urging FDA to review transparency requirements to ensure that the public is given accurate information both pre- and post-approval.

What does “Transparency at FDA” mean?

In the United States, the Freedom of Information Act (FOIA) was passed after Watergate so that people could ask federal agencies for information about their actions. The agencies, including the FDA, are required to provide the information unless the information is protected by special exemptions. The exemptions are intended to protect individuals, corporate entities and national security. One exemption (Exemption 4) covers:

• Trade secrets such as valuable formulas or processes
• Confidential business information including sales data, technical designs, customer lists, supplier lists, financial data, research data

Generally speaking, discussions between the Food and Drug Administration (FDA) and research sponsors such as drug companies fall under this exemption. In other words, communications between FDA and sponsors are confidential, and thus are not transparent. The assurance of confidentiality allows for free-flowing communication between FDA and the sponsor. Violation of the confidentiality can be considered a criminal offense.

This applies only to non-public information. Once information is made public anywhere, the FDA is no longer required to protect it.

For example …

Here’s a very simple example of what that looks like. When a research sponsor – typically a drug company – has research showing that their treatment helps patients, the sponsor submits the data to the FDA, and asks for approval based on that research. The FDA reviews the application and has several options – they can:

· Approve
· Disapprove
· Refuse to accept the application
· Request additional data

If the application is approved, the research results are summarized in the drug’s label, usually after extensive negotiations between the sponsor and the FDA. In the other situations, the FDA sends a very detailed letter to the sponsor that explains its concerns. The sponsor does not have to release the letter to the public. All communication between the sponsor and FDA is confidential unless the FDA holds a formal public advisory meeting such as an Oncology Drug Advisory Committee (ODAC) meeting, and even then, the FDA can reveal only the information necessary for expert review by the committee. If a drug is disapproved, the public generally does not know why.

Why do both confidentiality and transparency matter?

Bringing a new drug to market takes, on average, over ten years and $800 million - $1.2 billion according to the Tufts Center for the Study of Drug Development. Companies need to protect information that, in the wrong hands, could jeopardize their investment.

At the same time, C3 believes that there are situations where patients should have access to FDA’s perspective, especially if FDA’s perspective differs greatly from the information made public by the research sponsor.

Want to know more?

For additional information about FOIA, see:

• Your Right to Federal Records (2006) This pamphlet is a joint publication of the Department of Justice and the General Services Administration concerning both the FOIA and the Privacy Act
• A Citizen’s Guide to the FOIA (2005) A guide to both the Freedom of Information Act and the Privacy Act prepared by the House Committee on Government Reform
• FDA-specific information about FOIA

FDA’s website has extensive information about drug development.