Transparency Industry Listening Session #1 Summary
Listening Session #1 (Drug and Biological Products Industries)
January 21, 2010
Silver Spring, MD
American Association of Blood Banks (AABB)
Richard Carnevale, M.D.
Animal Health Institute
Biotechnology Information Organization (BIO)
Jeffrey Francer and Alan Goldhammer,
Pharmaceutical Research and Manufacturers of America (PhRMA)
Jennifer Stotka, M.D.
Eli Lilly, on behalf of PhRMA
Bridget Rossiter Elis,
Plasma Protein Therepeutics Association (PPTA)
Summary of Listening Session:
The meeting was chaired by Joshua Sharfstein, MD, Principal Deputy Commissioner, FDA and attended by members of FDA’s Transparency Task Force, as well as the industry participants listed above. Industry participants offered the following suggestions for improving FDA transparency to regulated industry. The views presented here do not necessarily represent the views of FDA or the Transparency Task Force.
A. Guidance Development
- Speed up and streamline the guidance development process. Guidances take too long to develop and stay in draft too long, depriving industry of information about how FDA currently views the subject of the guidance, and encouraging inconsistent application of policies across review divisions. (Some divisions implement draft guidances and some do not.) FDA may need more medical reviewer resources to achieve faster guidance development.
- If a guidance is in draft longer than 12 months after the close of the comment period, FDA should republish it for comment so that the final draft is up to date.
- Provide information on the status/progress of draft guidances.
- Update existing guidances in a timely manner. For example, many guidances need to be updated to include FDAAA requirements added since 2007.
- Communicate with industry during early guidance development. Some FDA officials currently take the position that they cannot interact with industry during even the early stages of guidance development. This position is unnecessary; FDA should not be barred from communicating with industry until a final draft is made public. Early consultations with industry are critical to developing successful guidances.
- Hold public meetings and workshops with all stakeholders—FDA, industry, academia—to aid guidance development. A good example is the dialogue session held by the Division of Metabolism and Endocrinology Products in 2009 to discuss how to assess cardiovascular risks with Type 2 diabetes drugs.
B. Product Development and Pending Applications
- Hold more meetings with individual sponsors to help ensure an adequate scientific dialogue and common understanding about what is expected during product development. Some requests for meetings are not being granted.
- Provide real-time tracking of applications to give sponsors a clear understanding of the status of their applications (assuming Internet security measures are adequate to protect the information from hackers).
- Establish a clear roadmap for sponsors about what actions will take place and when in the review of their application, e.g., will the Division issue a 74-day letter, will there be an orientation meeting? The review process can be unclear and unpredictable to sponsors without this transparency.
- Provide better information to applicants when new scientific issues arise. At these times, review divisions should grant additional meeting requests and provide more detailed information about the basis for FDA’s new concern, especially if FDA is requesting additional data from the sponsor. Currently, new meetings are not granted, and reviewers do not provide applicants sufficient information to understand the rationale for FDA’s decisions.
- Include medical officers in mid-term status reviews, not just project managers. Project managers sometimes lack sufficient information or expertise to explain the bases for FDA concerns and new requests.
- Communicate earlier about major concerns in application review. Sometimes the Office of Surveillance and Epidemiology (OSE) raises safety issues at the very end of the review process.
- Initiate earlier communication about milestones that now occur at the very end of the review process, e.g., labeling and REMS.
C. Safety Issues
- Share information with sponsors about the methods FDA has used in concluding that there is a safety problem with a product. Methodology often is not provided to the sponsor, and as a result, the sponsor cannot adequately respond to FDA or point out any potential errors in FDA’s analysis.
- Provide more information about how FDA reconciles disputes between the Office of New Drug Evaluation (OND) and OSE about safety issues, both in general and in specific cases. Companies are left in the dark about the basis for an FDA decision if they don’t know how a dispute was resolved. This makes it difficult to implement decisions or explain them to customers and investors.
- Warn sponsors at least 24-72 hours in advance of communicating emerging safety information to the public. Companies are not prepared to respond to public inquiries if they do not have advance notice that FDA is notifying the public of a safety issue about one of their products.
D. Communications to Industry--General
- Avoid FDA jargon in communications to industry.