Legislative Letter Writing Toolkit - Policy and Legislative Advocacy Advisory Group 2012-2013 - Sample Letter Outline - Background Summary on PDUFA

Sep 16, 2026

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Legislative Letter Writing Toolkit guides pharmacy students in building an effective legislative advocacy outreach by using clear, targeted letter communication. It explains why participation matters in a democratic system and how concise advocacy messages can influence elected officials and healthcare outcomes. The toolkit provides a reusable sample letter outline and a background summary of the Prescription Drug User Fee Act (PDUFA), including key provisions related to preventing drug shortages, along with an example support letter structure.

LanguageEnglish

CategoryLetters

FormatPDF

Pages6

Reading Time2 min

AccessFree to download

Introduction

Sample Letter Outline

Background summary: H.R. 5651/S. 3187 - PDUFA

Sample Letter

References

Legislative Letter Writing Toolkit Policy and Legislative Advocacy Advisory Group 2012-2013 Table of Contents Introduction ......................................................................................................................................2 Sample Letter Outline .......................................................................................................................3 Background summary: H.R. 5651/S. 3187-PDUFA ..............................................................................4 Sample Letter ....................................................................................................................................5 References.........................................................................................................................................6 INTRODUCTION Dear Pharmacy Professional, There is a saying that “politics precede policy,” and whether we want it or not, we know it is a true statement. Before a policy is created and goes into effect, before a bill becomes a law, there usually exists much discussion and deliberation about the specific provisions of the measure at hand. As much as we would want for the resultant laws to be effective and fair to all of the stakeholders affected by the provisions of the law, this is not always the case. As active members of the healthcare team, pharmacists need to take a proactive approach in the legislative process in our democratic society. It is important to remember that our system of government is based upon participation, those who make noise are generally heard. Conversely, silence is often viewed as acceptance. Pharmacists and pharmacy students alike, need to take an active role in informing their elected officials about the appropriate measures that are essential to improve health care. This is achieved through improved utilization of skills and services pharmacists can provide to the patients. One can communicate with elected officials through various viable means; phone calls, personal visits, sending letters electronically, or via mail. However, many individuals do not utilize these opportunities due to the underestimation of the impact a simple letter, phone call, or visit can make. At the sametime, those who see and seize the opportunities to make their voice heard by contacting their senators or representatives are successful with expressing their feelings. Submitting a document, as fundamental as a letter, can make a difference in the legislative decision-making process. This toolkit was designed to serve as a resource to help students initiate an effective letter writing campaign to support the pharmacy profession. Provided is a sample letter outline, which can be applied to any pertinent issue. In addition, the background summary on the Prescription Drug User Fee Act (PDUFA) and the sample letter of support for PDUFA, provide examples of how to utilize the letter outline. This allows students with a means to create an effective letter based on a description of an issue pertinent to pharmacy. Best of luck! SAMPLE LETTER OUTLINE [Your Name] [Address] [City, State, Zip] [DATE] The Honorable [Legislator Name][Governing Body, ex. United States Senate][Office Address] [Office City, State, Zip] Re: [Brief statement of what you want the legislator to do. Ex. Pledge to vote for H.R. 1234] Dear [Representative/Senator] [Legislator Last Name], I am a pharmacy student at [School Name] . I am writing to ask you to [clear statement of what you want the legislator to do. Ex. vote for H. R. 1234.] As a constituent of yours, I hope that you will consider [support or standing against the issue] . [Explain the issue and how it impacts patients and the healthcare system. Consider including stories from your personal experience to give your letter more impact. Remember to be concise. Legislators are busy and a concise letter with a few well thought out points will be more effect

FAQs

Why should pharmacists actively write letters to elected officials?

The toolkit explains that legislation is shaped by discussion before a bill becomes law, and participation is key in a system where those who make noise are generally heard. Writing letters helps pharmacy professionals inform officials about measures essential to improve healthcare.

What structure does the toolkit recommend for a sample legislative letter?

It provides placeholders for the sender’s name, address, date, legislator contact line, a “Re:” line stating the request, and a greeting. The body should clearly state the ask, explain the issue concisely, and close by thanking the legislator and inviting questions.

What is the Prescription Drug User Fee Act (PDUFA) and what does it authorize?

PDUFA, enacted in 1992, authorizes the FDA to require pharmaceutical manufacturers to pay fees for expedited review of new drug applications or biologics license applications. It has been reauthorized multiple times and amended with new provisions each cycle.

How does PDUFA V address drug shortages?

The toolkit notes that PDUFA V includes provisions giving the FDA tools to better manage shortages of life-saving medications. It describes a requirement for manufacturers to report discontinuance or significant interruption of life-sustaining or related drugs, with notice timing set before disruption or as early as practicable.

Sep 16, 2026

Upload by Miles