In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help fulfill President Obama’s commitment to openness in government and the U.S. Department of Health and Human Services (HHS) goal of making transparency a priority.
To carry out the Transparency Initiative, Commissioner Hamburg formed an internal Transparency Task Force, chaired by outgoing FDA Deputy Commissioner Joshua Sharfstein, MD, to develop recommendations for enhancing transparency of FDA’s operations and decision-making processes. Last week, the Task Force released its report entitled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.”
Transparency Initiative
Since its creation, the Task Force held two public meetings, launched an online blog, held listening sessions with members of regulated industry, and opened a docket to which comments could be submitted. The Task Force is proceeding with the Transparency Initiative in three phases.
Phase 1: FDA Basics for Industry: The goal for this Web site is to save many companies time and resources in understanding how to work with the agency. This resource now includes (1) 158 questions and answers about FDA and the products that the Agency regulates, (2) nine short videos that explain various agency activities, and (3) conversations with fourteen agency officials about the work of their Offices, including Commissioner Hamburg.
FDA also established an online program performance program, FDA-TRACK, with monthly metrics on more than 100 FDA offices, and proposed for discussion a series of steps to provide more public understanding of FDA decision-making and promote innovation.
Phase 2: Public disclosure: The second phase relates to FDA’s proactive disclosure of information the agency has in its possession, and how to make information about agency activities and decision-making more transparent, useful, and understandable to the public, while appropriately protecting confidential information. On May 19, 2010, the Task Force released a report containing 21 draft proposals about expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information. The Task Force is reviewing the comments received and will recommend specific proposals to the Commissioner for consideration.
Phase 3: Transparency to regulated industry: The Task Force held listening sessions and solicited comments about ways to improve transparency to regulated industry. The Task Force received public comments from small and large companies requesting transparency about the standards and expectations to which their products are held, the process for soliciting guidance from the agency, and the progress of regulatory efforts at the agency.
Executive Summary
From the public comments, the Task Force put together 19 action items and five draft proposals to address ways that FDA can become more transparent to regulated industry in order to foster a more efficient and cost-effective regulatory process. The report groups the action items and draft proposals into five categories:
- Communicating Information About Agency Procedures
- Product Application Review Process
- Guidance Development
- Regulations Development
- Import Process
Better communication: Six action items commit the agency to improving communication to industry about agency procedures:
- FDA Basics for Industry, noted above, which will provide basic information online about the regulatory process governing FDA-regulated products, and include information that is frequently requested by industry.
- FDA will update the agency organizational charts and senior leadership personnel changes on the FDA Web site on at least a quarterly basis and ensure detailed organizational charts are consistent across the agency.
- FDA will provide links to the processes available for industry to submit general regulatory questions to each Center.
- FDA will also aim to respond to general questions about an existing policy, regulation, or the regulatory process that are submitted via email, whenever practicable, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time for response.
- FDA will finalize the “Strategic Priorities FY 2011-2015” by March 2011.
- FDA will post on the FDA Web site slide presentations that are delivered by FDA employees to external audiences at events sponsored by, or co-sponsored by, the agency.
A More Transparent Review Process: Four action items focus on improving transparency during the product application review process:
- FDA will compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the web-based resource, FDA Basics for Industry.
- FDA will describe the types of notifications the agency provides to industry with respect to the product application review process. FDA will provide an overview of the processes used to strive for consistency of product application review.
- FDA will also communicate general expectations about the circumstances, if any, under which it is appropriate to use secure email between FDA and a manufacturer when there is a question involving the manufacturer’s product.
- FDA will explain how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action on the application. FDA is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.
Guidance and Regulations: Two action items focus on greater transparency around the guidance development process and two action items focus on transparency of the regulations development process:
- Commissioner Hamburg has formed a cross-agency workgroup to identify the best practices for improving the agency’s work on guidance.
- FDA will describe the ways in which interested individuals can provide input to the agency about guidance development. Links that provide industry with a list of guidance documents that have been withdrawn during the past year as well as possible topics for future guidance development or revision also will be made accessible in one location on the FDA Web site.
- After FDA issues a final rule, FDA will conduct outreach to the affected stakeholders as part of implementing the final rule if the rule imposes substantial new obligations.
- FDA will also work with the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB) to improve the accuracy of the timetables included in the agency’s regulatory agenda published as part of the Unified Agenda.
Communications with Importers: Five action items focus on improving transparency to the importing community:
- FDA will provide contact information for points of contact within each District to whom to direct questions about the import regulatory process.
- FDA will allow the public to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated.
- As part of the agency’s efforts to implement the forthcoming Strategic Import Plan, FDA will develop and execute a project to promote more uniform processes and procedures across districts, when appropriate. This project will be tracked on FDA-TRACK, the FDA’s agency-wide performance management system.
- FDA will aim to respond to general questions about the import process, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time for response. The Division of Import Operations and Policy in the Office of Regulatory Affairs will compile a list of answers to questions frequently asked by industry and post this information on the FDA Web site.
- FDA will work with U.S. Customs and Border Protection to explore developing a process by which brokers and filers can correct inadvertent data errors submitted about imported products and FDA should post that process online.
Draft Proposals
In addition to the above steps, FDA is requesting comments on five draft proposals to improve transparency to regulated industry, including:
- Disclosing, for certain high priority guidance documents in development, a timeline from the start of the agency’s work on the draft guidance to publication of the final guidance
- Posting on the FDA Web site a list of presentations given by FDA employees to external audiences
- Informing submitters if an appeal request will be reviewed by the FDA Commissioner and when a decision may be expected
- Reviewing existing procedures to evaluate importers, or third parties working on behalf of importers, who file information electronically about products offered for import, and
- Initiating a planning process to develop a web-based system that provides information about importing requirements.
Discussion
The outcome of these proposals and the implementation of the action items are significant, as many companies struggle with the difficult regulatory process and landscape at the FDA. For example, FDA approved only 21 new drug approvals in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007, according to an analysis by the Wall Street Journal.
While FDA spokeswoman Sandy Walsh said there’s “no systemic change in how the FDA is approaching drug approvals,” companies often face obstacles with getting timely responses and information about drug approvals, marketing, new indications, and various other parts of the drug approval process. Nevertheless, this report, along with the FDA Transparency Initiative, seems to be a step in the right direction, especially considering the large role industry seems to be playing in working with the agency.
As FDA continues to provide more resources to guide companies about the regulatory and drug approval process, investors can continue funding such projects and research and development budgets can be tailored accordingly to focus on new diseases, orphan drugs, and other therapeutic areas. This increased level of communication and reliability on timelines will lead to better treatments for patients that will reach them in a timely manner.
Comments
FDA is soliciting public comment on the five draft proposals at www.regulations.gov until March 6, 2011 (docket number FDA-2009-N-0247). After considering public comment on the draft proposals, the Task Force will recommend specific proposals to Commissioner Hamburg for consideration. FDA will begin to implement the 19 action items in the report in 2011.