FDA-TRACK Health Care Reform

Sign up to receive FDA-TRACK email updates

 

FDA-TRACK Health Care Reform will track FDA’s progress on implementing FDA projects in the recently passed Patient Protection and Affordable Care Act (ACA). Several of these projects require the efforts of external partner organizations and/or multiple FDA Offices. A brief summary of each project is provided below.

• Section 3507 - Presentation of Prescription Drug Benefit and Risk Information - Quantitative information about the risks and benefits of prescription medications presented in a standard format may help clinicians, patients, and consumers make more informed health care decisions. FDA is currently undertaking three studies and a literature review about this in order to provide a recommendation to Congress about implementing a standardized way to present benefit and risk information on prescription drug labels and in advertising.
• Section 3509 - Improving Women's Health - Women may respond differently to pharmaceuticals than men and they have historically been underrepresented in clinical trials and analysis of their results. The FDA Office of Women’s Health was established to protect and advance the health of women through policy, science, and outreach.
• Section 4203 - Removing Barriers and Improving Access to Wellness for Individuals with Disabilities - Currently, disabled patients may not receive necessary medical treatment because of barriers to their use of medical equipment. FDA is working with the Architectural and Transportation Barriers Compliance Board (the Access Board) to set standards to improve the accessibility of medical diagnostic equipment for individuals with accessibility needs. This will improve the public health by allowing greater access to medical and diagnostic equipment regulated by the FDA.
• Section 4205 - Nutrition Labeling of Standard Menu Items at Chain Restaurants - Nutrition labeling information is rarely made easily available in restaurants. As a result, Americans may find it difficult to make well informed diet decisions when eating away from home. FDA is working to implement nutrition labeling regulations for standard menu items in chain restaurants and similar retail food establishments, and on vending machines. With these new regulations in place, important nutrition information about menu items will be readily available. This will provide Americans with the information they need to be able to make healthy, informed diet decisions.
• Section 7002 - Approval Pathway for Biosimilar Biological Products - The Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which is contained in the Affordable Care Act, established a new abbreviated pathway for FDA licensure of biological products that are demonstrated to be highly similar to (“biosimilar”) or “interchangeable” with an FDA-licensed reference biological product so that Americans have access to safe, effective, and lower cost alternatives.  FDA is working to clarify the new abbreviated licensure pathway to encourage development of biosimilar and interchangeable biological products, leading to increased access to biological products and decreased costs for patients using them.
• Section 10334 - Minority Health - Minorities may respond differently to medications than non-minorities and have been historically underrepresented in clinical trials. FDA's Office of Minority Health (OMH) will work to eliminate racial and ethnic disparities and to improve minority health and the quality of health care minorities receive. Some of the activities OMH will be engaging in to fulfill its mission include: advocating within and outside FDA for the appropriate participation of minorities in clinical trials and analyses of subpopulation data, communicating FDA information to minority groups, and promoting the participation of minority health professionals in FDA activities.
   
• Section 10609 - Labeling Changes - Prior to passage of the Affordable Care Act (ACA), generic drug approvals could be delayed if the sponsor of the reference listed drug (RLD), the approved drug product to which new generic versions are compared to show that they are bioequivalent, made a change to the RLD label shortly before the generic drug approval. FDA has established a specialized approval letter to use in this circumstance so that FDA can approve the generic drug and permit the sponsor 60 days to revise the label according to the changes made in the RLD label. This specialized approval letter will not be used if the changes to the RLD label were related to certain safety information.