FDA's Transparency Initiative: New Life in a Glass House?

by James Goodwin

In 2007, the FDA came under criticism for failing to inform the public about studies it had had for two years which indicated that users of the diabetes drug Avandia faced up to a 42% greater chance of suffering a heart attack.  More recently, it was revealed that Bush-era political appointees at the agency surreptitiously worked with chemical industry representatives to downplay evidence of the adverse health effects caused by bisphenol A (BPA), a chemical frequently used in making plastic toys and baby bottles.  Thanks to scandals like these, the FDA has long been dogged by criticisms for the lack of transparency with which it conducts regulation.

The Obama Administration says it will be taking on the issue.  The FDA announced Tuesday that it would be beginning a process to enhance “the transparency of the agency’s operations and decision-making process.”

To carry out this new initiative, the FDA has formed a “Transparency Task Force” to be chaired by Principal Deputy FDA Commissioner Joshua Sharfstein (the former Baltimore City Health Commissioner and a long-time advocate for clean science in medical policy).  The Transparency Task Force has been charged with preparing a report for the FDA Commissioner Margaret A. Hamburg with findings and recommendations on the following questions:

  • How can the agency better explain its operations compatible with the appropriate protection of confidential information?
  • What information should the FDA provide about specific agency operations and activities, including enforcement actions and product approvals?
  • What problems and barriers, both internal and external, does FDA face to providing useful and understandable information about the agency’s activities and decision-making to the public?
  • What appropriate tools and new technologies are available that the FDA can use for informing the public?
  • What changes to the FDA’s current operations, including internal policies and guidance, can be made to improve the agency’s ability to provide information to the public in a timely and effective manner?
  • What legislative or regulatory changes, if appropriate, can be made to improve the FDA’s ability to provide information to the public?

Needless to say, the move by FDA toward greater transparency is long overdue.  One transparency problem at FDA is the way in which the agency deals with confidential business information.  The Federal Drug and Cosmetic Act (FDCA) authorizes the FDA to take certain limited steps to protect the trade secrets of companies that manufacture pharmaceuticals and medical devices in the course of regulating these industries.  Over time, this narrow, discretionary exemption has expanded greatly, and as a result the protection of public health has had to take a backseat to the overbroad confidential business information claims by regulated industry.  The abuse of this exemption severely undermines the statutory goal of the FDCA to improve regulation of pharmaceuticals and medical devices through information disclosure.

In Saving Science from Politics: Nine Essential Reforms of the Legal System, CPR Member Scholars recommend a number of different ways in which such unwarranted confidential business information claims can be prevented.  In particular, they recommend that the scope of information that may be properly characterized as confidential information be delimited with much greater specificity; that companies making a confidential business information claim assume the responsibility of providing a thorough explanation of why the claim is justified; that justifiable confidential business information claims automatically expire after a reasonable time unless the business making the claim can provide a thorough justification for why the claim should be extended; and that the president reestablish the presumption of disclosure under FOIA.  So far, it is encouraging that one of the first acts of the new Obama Administration was to reestablish this presumption of disclosure.  It's even more encouraging that the Obama Administration also appears to recognize the more specific transparency problem at FDA caused by the abuse of confidential business claims.

As it assembles its report for the FDA Commissioner, the Transparency Task Force will seek the input of FDA employees, regulated industry, and the general public;  FDA will  host the first of two public meetings on June 24, 2009, with the second to follow sometime in the fall of 2009.  (Alternatively, interested individuals can submit comments in writing through August 7, 2009.)

Member Scholars of CPR have long been fierce critics of the lack of transparency at the FDA; not only does the lack of transparency fly in the face of democratic principles, it also greatly inhibits the ability of the FDA to protect the health and safety of all Americans.  I hope this week's announcement is the start of a process that goes a long way to change that.



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