January 19, 2011: FDA-TRACK Health Care Reform Quarterly Briefing Summary

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Section 3507 – Presentation of Prescription Drug Benefit and Risk Information

• The Center for Drug Evaluation and Research’s (CDER) Division of Drug Marketing, Advertising, and Communication (DDMAC), has begun conducting studies required under Section 3507 of the ACA. DDMAC is working with partners to complete a literature review of scientific evidence and research about decision making and cognitive psychology. DDMAC is on track to present the results of the literature review to the November 2011 meeting of the FDA Risk Communication Advisory Committee. DDMAC will incorporate the Risk Communication Advisory Committee’s reviews and recommendations into the final report submitted to Congress about the addition of quantitative summaries of benefit and risk information on prescription drug labels and advertisements.

Section 3509 – Improving Women’s Health

• As a part of the Office of Women’s Health (OWH) effort to examine the inclusion of women in clinical trials, OWH awarded intramural funding to the Center for Drug Evaluation and Research (CDER) to study this in applications submitted from 2007 through 2009. Funding and initial tracking for this project have been completed. OWH and CDER expect the sex-based analysis of these clinical trials to be completed in the next several months.
• OWH presented their recently developed education fact sheets and brochures about diabetes. These educational materials were developed in several languages to provide women with additional free information to help manage diabetes. Visit the Women and Diabetes web page to download these educational materials and learn more about managing diabetes.

Section 4203 – Removing Barriers and Improving Access to Wellness for Individuals with Disabilities

• The Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEL) reported on work done with the Architectural and Transportation Barriers Compliance Board (Access Board) to review and determine the priority medical devices to examine under the ACA. OSEL and the Access Board are now working to analyze the gaps in medical device accessibility standards and draft new standards to address these gaps.

Section 4205 – Nutrition Labeling of Standard Menu Items at Chain Restaurants

• The Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Foods (OF) have published a Federal Register notice opening a docket to solicit public comments about FDA’s implementation of Section 4205 of the ACA, published a Federal Register Notice for implementation of voluntary registration for firms not covered by the ACA, and published a final guidance on the impact of Section 4205 on State and local laws.  CFSAN and OF have reviewed the comments received and are working to meet the March 23, 2011 statutory deadline for publication of a draft proposed rule.

Section 7002 – Approval Pathway for Biosimilar Biological Products

• FDA established a multi-Center committee responsible for the implementation of Section 7002 and the Biologics Price Competition and Innovation (BPCI) Act of 2009. The committee meets regularly and includes members from the Office of the Commissioner (OC), the Center for Biologics Evaluation and Research (CBER), and the Center for Drug Evaluation and Research (CDER).
• FDA published a Federal Register Notice announcing a Part 15 Hearing which was held in November 2010. The hearing and docket allowed stakeholder groups to provide input to FDA on various issues and challenges associated with implementing an abbreviated approval pathway for biological products that are highly similar or interchangeable with an FDA-licensed biological product. The purpose of this public hearing was to create a forum for interested stakeholders to provide input regarding the agency’s  implementation of the statute concerning the following issues, among others: Scientific and technical factors related to a determination of biosimilarity or interchangeability; the type of information that may be used to support a determination of biosimilarity or interchangeability; development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products; scope of the revised definition of a ‘‘biological product’’; priorities for guidance development; scientific and technical factors related to reference product exclusivity; scientific and technical factors that may inform the agency’s interpretation of ‘‘product class’’ as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and the establishment of a user fee program for biosimilar and interchangeable biological products. The docket closed on December 31, 2010.  Additional information about the public hearing, including transcripts, is available on the FDA website.

Section 10334 – Minority Health

• Representatives from the Office of the Commissioner provided an updated on their plans to establish a new Office of Minority Health under the ACA. Outreach about FDA’s minority health activities is being planned in concert with FDA Centers and offices. 

Section 10609 – Labeling Changes

• The Center for Drug Evaluation and Research (CDER) Office of Generic Drugs (OGD) has completed their requirements under the ACA. OGD implemented revisions to the Abbreviated New Drug Application (ANDA) approval letter ensuring that ANDAs with outdated labeling can be approved, if the reference listed drug labeling was changed within 60 days of the event that cleared the way for generic competition. In instances when this revised ANDA approval letter is issued, the generic drug sponsor must agree to submit a revised label within 60 days.  OGD has also developed a Manual of Policy and Procedure which has been put into place to assure a consistent application of the new provision and to track its use.