HHS/FDA Preliminary 21st Century Plan to Review Existing Regs
The Department of Health and Human Services has issued its Preliminary Plan for Retrospective Review of Existing Rules, which is required under Executive Order 135361 and is part of the President’s plan to create a “21st-century regulatory system.” HHS' review plan includes Food and Drug Administration regulations on current Good Manufacturing Practices, preventive controls for food facilities pursuant to the Food Safety Modernization Act, etc.
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(The White House recently posted 30 preliminary plans for “21st Century” regulations that were submitted by government agencies, including the State Department’s. See ITT’s Online Archives or 05/31/11 news, 11053130, for BP summary.)
Plan Aims to Increase Transparency, Public Participation, Etc.
HHS' retrospective review plan has four goals: (i) increase transparency in the retrospective review process; (ii) increase opportunities for public participation; (iii) set retrospective review priorities; and (iv) strengthen analysis of regulatory options.
CGMP, FSMA Preventive Controls, Etc. Candidates for Review Over Next Two Yrs
The following FDA rules are on HHS' initial list of significant rules that are candidates for retrospective review over the next two years:
CGMP/FSMA controls for food facilities -- FDA is reviewing its current Good Manufacturing Practices (CGMP) regulations, both for foods and drugs. As a primary initiative and pursuant to the Food Safety Modernization Act (FSMA), FDA will establish preventive controls for food facilities to address and modernize the CGMP for food establishments. CGMP regulations pertaining to pharmaceuticals are also fit for this initiative, and revisions would accommodate advances in technology and control of components.
Nutrition & pharma labeling -- FDA is pursuing reviews to revise and update labeling regulations for both food and drugs. As part of its Nutrition Initiative, FDA intends to review and revise the food label regulations to improve and increase the nutrition information available to consumers and help them make better choices about the foods they eat. In a related effort, FDA intends to begin a review of its regulations relating to patient packaging and inserts for pharmaceuticals to determine whether information can be communicated in a more direct and understandable manner.
National drug codes -- FDA will assess the costs and benefits of the “Bar Code Rule” to determine if the rule should be modified to take into account changes in technology since the rule went into effect in 2004. The Bar Code Rule requires certain human drug and biological products to have a linear bar code on their labels that contains the drug's National Drug Code (NDC) number. This rule allows health care professions to use bar code scanning equipment to verify that the right drug is being given to a patient at the right time.
Electronic reports & submissions for drugs -- FDA will revise regulations to permit electronic submission of clinical study data for drug trials, post-market reporting for drugs and biological products, and registration and listing of drugs and medical devices. FDA is also looking to require electronic package inserts for human drug and biological products.
Pre-market review for medical devices -- FDA and Centers for Medicare and Medicaid Services (CMS) intend to pilot a voluntary process for the parallel review of medical devices for marketing that will reduce the total combined time it takes for a medical device to be authorized for sale in the marketplace, etc. FDA has established two initiatives to improve the premarket review. First, FDA is implementing a Medical Device Innovation Initiative to support the development of innovative products by addressing some of the barriers that can impede a product’s timely progress to market. Second, FDA is implementing the 510(k) Plan of Action, which calls for 25 actions during 2011 to improve the most common path to market for medical devices.
Validated symbols for device labeling -- FDA intends to allow validated symbols in certain device labeling without the need for accompanying English text. FDA believes this change will reduce the burden of having unique labeling requirements for the U.S. market and achieve consistency with labeling requirements for international markets.
1On January 18, 2011, the President issued EO 13563, "Improving Regulation and Regulatory Review," which requires retrospective review of significant rules. EO 13563 requires each Executive Branch agency to develop a preliminary plan to periodically review its existing regulations to determine whether any regulations should be modified, streamlined, expanded, or repealed so as to make the agency’s regulatory program more effective or less burdensome in achieving its regulatory objectives. The plans were due to the Office of Management and Budget by May 18, 2011. (See ITT’s Online Archives or 01/19/11 news, 11011915, for BP summary.)
(See ITT's Online Archives or 04/13/11 news, 11041314, for BP summary of HHS seeking comments on its plan.
See ITT's Online Archives or 06/07/11, 06/06/11, 06/03/11, 06/02/11, and 06/01/11 news, 11060702, 11060303, 11060302, 11060204, and 11060121, for BP summaries of the Departments of Agriculture, Energy, Treasury, State and Homeland Security's preliminary plans.)