Foundations of Regulation

1. Foundations of Regulation Diane L. Heinz, DVM, MBA Director Policy and Regulations Staff Center for Veterinary Medicine

2. Laws and Regulations • The Federal Government is composed of three distinct branches: legislative, executive, and judicial, which powers are vested by the U.S. Constitution • The Legislative Branch of the Federal Government consists of the elected House of Representatives and the Senate, which together form the United States Congress

3. Laws and Regulations • The Constitution grants Congress the sole authority to enact legislation • Bills are passed by Congress and signed into law by the President

4. Laws and Regulations • A new law often does not include all the details needed to explain how an individual, business, state or local government, or others might follow the law • The Executive Branch of the Federal Government is responsible for the day-to-day enforcement and administration of federal laws

5. FDA - Laws and Regulations • The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws establish the legal statutory framework within which FDA operates • The FD&C Act can be found in the United States Code, which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301 • Over 200 laws since 1906 that authorize and direct the regulatory activities of the FDA

6. What is a rule? • Rule - issued pursuant to statutory authority, implements a law, and has the force and effect of law • “Regulation” is the common name for a rule that imposes regulatory requirements • FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates

7. Regulation • Violation of a validly adopted regulation can result in a sanction just as severe as one received for violation of a statute passed by Congress • To have the force of law a regulation must be issued under a delegation of authority from Congress and according to appropriate rulemaking requirements

8. Regulation • The Administrative Procedure Act (APA) of 1946 • Law that governs the way in which agencies of the Federal Government may propose and establish regulations • Notice-and-comment rulemaking

9. Advance Notice of Proposed Rulemaking (ANPRM) • Used as a vehicle to involve the interested public in a regulatory action at an early stage, before the agency has arrived at even a tentative decision on a particular regulatory change • Sometimes used to test public reaction to a proposal • Not a requirement of the rulemaking process

10. Notice of Proposed Rulemaking (NPRM) • Informs the public that a federal agency is considering a regulatory change • Describes the new rule or changes being considered to an existing rule • Public is invited to participate by submitting written comments to the agency

11. Final Rulemaking • After considering all public comments to a proposed rule • Published with agency’s conclusions on comments and thorough explanation of reasons for decisions

12. Direct Final Rule • Published first as a final rule with an accompanying statement indicating the rule will take effect in X days unless someone submits a significant adverse or negative comment within a stated number of days • If significant adverse comment received, proceed with normal notice-and-comment rulemaking • Used when agencies are confident that a rule will be non-controversial

13. Code of Federal Regulations • Once a regulation is completed and has been published as a final rule, it is codified when it is added to the Code of Federal Regulations (CFR) • The CFR is the official record of all regulations created by the Federal Government • It is divided into 50 volumes, called titles, each of which focuses on a particular area • Almost all food and drug regulations appear in Title 21

14. Established in 1935 by the Federal Register Act Published by the Office of the Federal Register Official daily publication of the Federal Government Provides notification and record of agency rulemaking actions and other notices and announcement of agency actions and meetings. Federal Register

15. Each Federal Register notice has a unique identifier, or docket number A docket is the file that includes all the relevant public information about the agency action identified in the notice and and to which the public can submit comments Docket

16. What are guidance documents? • Guidance - a statement of policy on a regulatory issue or an interpretation of a statute or regulation • Represents the Agency’s current thinking on a regulatory issue • Used to communicate new or different regulatory expectations to a broad audience

17. Guidance Documents • Guidance documents are prepared to establish clarity and consistency in FDA policies, regulatory activities, and inspection and enforcement procedures • Guidance documents provide industry with specific recommendations on how to comply with the statutes and regulations and avoid enforcement actions

18. Guidance Documents • Do not have the force and effect of law • Not compulsory • An alternative approach can be used if the approach satisfies the requirements of the applicable statutes and regulations

19. Guidance Documents • Guidance documents may relate to the: • design, production, labeling, promotion, manufacturing, and testing of regulated products • the processing, content, and evaluation or approval of submissions • inspection and enforcement policies

20. When are guidances developed? • Ideas for development of guidance may come from FDA staff, regulated industry, or the public • The public is encouraged to suggest topics for guidance documents and to participate actively in the guidance process • Early input through FDA-sponsored public meetings and workshops • Submission of draft or revised guidances

21. When are guidances developed? • Each Office within CVM may receive suggestions or drafts of guidance and may meet with industry, trade groups, or consumer groups to come up with new guidance approaches • If the same subject matter and policy relates to more than two or three persons or firms, it might indicate that guidance should be developed in that area

22. Guidance Development • FDA is required to annually publish a guidance agenda that lists possible topics for future guidance document development or revision during the next year • This enables the public to see what the Agency is working on

23. Guidances • FDA’s Good Guidance Practices (GGP) regulation ( 21 C.F.R. § 10.115) governs the development and issuance of guidances, and it gives interested persons a number of opportunities to provide input into the guidance development process

24. Level 1 Guidance • Set forth first interpretations of statutory or regulatory requirements; • Set forth changes in interpretation or policy that are significant; • Include complex scientific issues; or • Cover highly controversial issues Most guidances are level 1

25. Level 2 Guidance • Set forth existing practices or minor changes in interpretation or policy • Include all guidance documents that are not classified as Level 1

26. Procedure for Developing Level 1 Guidance • Draft guidance is made available for public comment (typically 60-day comment period) • Draft guidance may be revised based on public comment • Final guidance is made available to public

27. Procedure for Developing Level 1 Guidance • However, FDA may implement a level 1 guidance immediately, without prior public comment, if • the Agency determines that prior public participation is not feasible or appropriate (e.g., if there is a real public health issue); OR • if a new statutory requirement, Executive Order, or court order requires immediate implementation

28. Procedure for Developing Level 2 Guidance • Level 2 guidance is made available to the public in final

29. Guidance Development • Public can comment on guidance at any time • Draft guidances have stated periods for public comment prior to finalizing the guidance, but the docket remains open for future updates and revisions • Guidance can be revised at any time • Advances in science or technology • New information • New policy

30. VICH Guidelines • VICH – International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products • International program of co-operation between regulatory authorities and the animal health industries • EU, Japan, and US (Australia, NZ, and Canada) • Includes both pharmaceutical and biological veterinary medicinal products

31. VICH Guidelines • The VICH recommends ways to achieve greater harmonization in the interpretation and application of technical guidances and requirements for product registration to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines

32. VICH Guidelines • Composed of delegates from regulatory authorities and industry • Discuss scientific and technical aspects of product registration • VICH experts ensure their parties are represented • The main “end-product” – a harmonized guideline that reflects scientific consensus regarding regulatory requirements

33. FDA and VICH Guidelines • FDA delegates ensure that VICH guidelines do not contradict United States statutory or regulatory requirements • VICH guidelines are revised to conform to FDA's good guidance practices regulation and published as guidances

34. Advisory Committees • Consistent with the Federal Advisory Committee Act, FDA has established advisory committees when it is in the public interest in connection with the performance of the Agency’s regulatory duties • FDA also has established some advisory committees as a result of specific statutory mandates

35. Advisory Committees • The procedures and rules that govern FDA’s advisory committee program are set forth in general terms in the Agency’s regulations (21 CFR Part 14)

36. Advisory Committees • FDA seeks input from advisory committees on a broad scope of complex issues related to the products it regulates • Advisory committee meetings also facilitate public discussion of important topics and provide a means for the public to provide comments to the Agency • Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing

37. Advisory Committees • FDA’s advisory committees provide independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to FDA-regulated products • These issues typically relate to a specific food or medical product, a class of foods or medical products, the development and implementation of a specific regulatory program, or the development and implementation of a regulatory policy

38. Advisory Committees • When not obligated by statute, FDA considers the following three factors in deciding whether to convene an advisory committee meeting: • Is the matter at issue of such significant public interest that it would be highly beneficial to obtain the advice of an advisory committee as part of the Agency’s regulatory decision-making process? • Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the Agency’s regulatory decision-making process? • Is there a special type of expertise that an advisory committee could provide that is needed for the Agency to fully consider a matter?

39. Advisory Committees • Examples of Scenarios: • FDA is evaluating a first-in-class antimicrobial for use in food-producing animals • FDA has significant questions or concerns regarding the development or implementation of a regulatory policy or guidance document • FDA has concerns regarding post-approval adverse events reported for an approved drug

40. Advisory Committees • Although advisory committees provide recommendations to FDA, FDA makes the final decisions on any matters considered by an advisory committee

41. Citizen Petitions • The First Amendment of the Constitution allows citizens to petition the government “in favor of or against policies that affect them or in which they feel strongly” • At the FDA, the citizen petition process (21 CFR Part 10) is used to request the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action

42. Congressional Inquiries • Members of Congress communicate through FDA’s Office of Legislation • Congressional inquiries include: • requests for information on specific CVM programs or policies • requests for information on behalf of constituents • requesting witnesses to appear at hearings • requesting technical assistance when drafting legislation

43. Office of the Ombudsman • Neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level • Works to resolve externally and internally generated problems for which there are no legal or established means of redress by finding approaches that are acceptable to both the affected party and to the Agency

44. Freedom of Information Requests • Freedom of Information Act provides that any person has a right to obtain access to federal agency records, except to the extent that such records (or portions of them) are protected from public disclosure

45. Foundations of Regulation • FDA encourages participation from all public stakeholders in its decision-making processes • Congress/Law • Regulation • Guidance • Advisory Committee • Citizen Petition • Freedom of Information Request