ADVOCATES CAN MAKE A DIFFERENCE ADVOCACY STRATEGIES FOR INTERACTING WITH REGULATORY AGENCIES
Federal • Advocates can and should monitor activities at CMS and FDA and other agencies, and provide either written or public comments where appropriate. Here is an online resource that can help you track and provide comments on proposed regulations. To learn more about submitting comments or petitions to a proposed ruling, visit: www.regulations.gov or www.fda.gov/ RegulatoryInformation/Dockets/Comments/ default.htm?utm_source=rss&utm_ medium=rss&utm_campaign=comment- onproposed-regulations-and-submit-petitions • FDA Patient Representative Program – The FDA encourages patients and patient representatives to participate in the FDA decision-making process. They recruit patient representatives on an as-needed basis. To learn more about applying for this program, visit: www.fda.gov/ForPatients/ About/ucm412709.htm • Providing comments to items published in the Federal Register is a great opportunity for advocates to participate in the rulemaking process, to tell regulators the possible effects of the proposed ruling for patients. To learn more about the Federal Register, visit: www. gpo.gov/fdsys
States • All states have state health regulatory boards, which include committees like the state Board of Medicine and the state Board of Pharmacy. Advocates can monitor activity, such as public hearing dates and agendas. Specific information is typically published in a state ‘register’, but many agencies maintain listserv or subscription services based on issue areas. Public hearings are an opportunity for advocates to express their views on important issues. To learn about your state Medical Board, visit: www.fsmb.org To learn about your state Board of Pharmacy, visit: www.nabp.net • Many state health departments allow advocates to provide comments, either written or in person, to the states Drug Utilization Review Board and Pharmacy and Therapeutics (P&T) committees. This is a valuable way for advocates to express their opinions regarding patient access to medications, or other drug-related issues. In addition to providing comments, many states also offer opportunities for consumer advocates to hold an official position on these review boards. To learn more about these potential opportunities, visit your state’s human serves or health department website.
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