IV. Existing Retrospective Review Requirements
HHS agencies currently conduct routine reviews of existing regulations pursuant to a variety of authorities or circumstances. For example:
- The Regulatory Flexibility Act requires agencies to conduct reviews every ten years of regulations that have a significant economic impact on a substantial number of small businesses.
- Yearly appropriations require review and publication of Medicare payment rules every year.
- Retrospective review often occurs when there is a significant change in circumstances, such as advances in technology, new data or other information, or legislative change.
- Finally, under 21 CFR 10.25(a) and 10.30, the FDA may review a regulation if a person submits a petition asking the Commissioner of Food and Drugs to issue, amend, or revoke a regulation.
Over the past several years, HHS agencies have issued a number of final rules as the culmination of a retrospective review. Additionally, HHS agencies are currently reviewing or revising rules within an existing regulatory review framework. For example, FDA has completed the following revisions as a result of its existing retrospective review activities:
- Constituent Materials in Biological Products (2011): The final rule amends the biologics regulations to permit, as appropriate, approval of exceptions or alternatives to the regulation for constituent materials. FDA is taking this action due to advances in the development and manufacture of safe, pure, and potent biological products that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive.
- Safety Reporting for Investigational New Drugs (2010): This final rule is expected to improve the quality of new drug safety reports submitted to FDA. The final rule lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing the reporting of meaningful, interpretable information, thereby enhancing the safety of patients in clinical trials.
- Expanded Access to Investigational Drugs for Treatment Use (2009): This final rule clarified existing regulations and expanded access to investigational drugs for treatment use to improve access for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies.