Sara Collina - Comment

The National Breast Cancer Coalition (NBCC) appreciates this opportunity to comment on ways in which the Food and Drug Administration (FDA) can make useful and understandable information about its activities and decision-making more readily available to the public. NBCC is a grassroots advocacy organization with the mission to eradicate breast cancer by focusing the administration, U.S. Congress, research institutions and consumer advocates on substantive approaches relating to breast cancer. To achieve this mission, NBCC has created and mobilized a powerful, effective and diverse network of trained grassroots activists, giving breast cancer a meaningful voice in Washington, D.C. and state capitals, in laboratories and health care institutions. Although NBCC applauds recent efforts by FDA to increase transparency and accountability, we are concerned about the “internal” nature of the Transparency Task Force. NBCC strongly believes that inclusion of educated health care consumers and trained advocates in the Transparency Task Force will greatly enhance transparency and accountability at FDA. The following are specific comments in response to the points outlined in the June 2009 Federal Register: 1. NBCC urges accessibility and timeliness in the materials that are provided regarding enforcement actions, product approvals, and other FDA activities. Current communications are biased towards those already in the know, including the pharmaceutical industry and government representatives and agencies. Consumers find themselves at a disadvantage, and there are a number of things that could be done to improve this situation: • A newsletter written specifically for consumers that addresses key policy issues in an intelligent and consumer friendly but not condescending way. • Earlier release of data embargoed for Oncology Drug Action Committee (ODAC) meetings. Currently, consumers must register to speak before seeing the evidence on a particular drug. Pharmaceutical companies always know that speaking will be in their best interest whereas consumers cannot judge or know if they should speak at the ODAC meetings until it is too late to register to speak. The deadline for registering should be at least a week after the release of the embargoed data. • Reports of adverse events for individual drugs should be available online as a matter of public record. Consumers should be able to access this information directly online. If FDA is especially worried about potential misunderstanding, the information should be available on request by anyone interested in the drug. 2. NBCC recommends FDA provide the following information regarding: • Enforcement actions: If a black box warning is issued (e.g., erythropoietin-stimulating agent), consumers should be able to find out the details of any enforcement action required by the manufacturer, a timeline for enforcement and any response. This information should be available online. • Product approvals: i. If FDA overrules an ODAC recommendation (e.g., Avastin®), the reasoning should be made clear and explicit. Such transparency will facilitate acceptance and understanding of consumers. ii. Provide complete information on your website about when and why FDA approved a drug and combinations of drugs. For example, we are analyzing breast cancer interventions, including all the drugs approved by FDA, and have found that often the information is simply not available. FDA staff advised that information about when and why certain combinations of chemotherapies were approved are no longer available to the public. 3. Additional communication with the Public: • FDA patient information leaflets are multiple and confusing. What is needed is a standardized and easy to read format that presents, in a simple tabular format, the risks and benefits of an intervention, along with alternative methods of dealing with the illness or condition. • The Drug Facts Box developed by Steve Woloshin and Lisa Schwartz of Dartmouth and recently presented to the FDA Risk Communication Advisory Committee is an excellent example of well-designed, accessible and meaningful patient information. We understand the committee came to a resolution recommending that FDA adopt something similar to the Drug Facts Box for the drug products it regulates. This change is not only important for improving the transparency of FDA, but is also essential to the administration’s goals around comparative effectiveness research. 4. Achieving the Goal of Transparency and Appropriate Public Communication As we mentioned in the beginning of this letter, while there is a push to determine how best to involve the public and communication with them, we must develop a system to ensure that public feedback is actually reviewed and incorporated and that their perspective is part of all decision making and oversight. Trained patient advocates who represent a constituency have a unique perspective that cannot be found elsewhere. They must be members of all boards, panels, committees and task forces at FDA. FDA missed an opportunity to incorporate this perspective when it created an internal task force on transparency. NBCC believes the best way to ensure that the committee truly reflects the perspective of patients – the ultimate stakeholder- is to include them on the committee itself. NBCC urges FDA to take these comments into consideration and looks forward to increased transparency and accountability at FDA and to working with the agency to achieve those goals. Please contact NBCC staff member Mina Suh at 202-973-0570 or msuh@stopbreastcancer.org with any questions or concerns. Sincerely, Sara Collina, on behalf of NBCC Research Accountability Committee