ISMPP Advocacy Initiatives
AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers - January 2017
AMWA, EMWA, and ISMPP released a Joint Position Statement on the Role of Professional Medical Writers on January 17, 2017, which is the first unified position on the role of professional medical writers from three leading professional organizations. The Joint Position Statement describes best practices for professional medical writers, and provides a template for appropriately disclosing medical writing support.
Note: This Joint Position Statement supersedes previous position statements and guidelines from participating organizations. Individual members are encouraged to update their own publication policies accordingly.
Articles and Presentations on the AMWA-EMWA-ISMPP Joint Position Statement
AMWA-EMWA-ISMPP Joint Position Statement - Presentation by Yvonne Yarker at ISMPP 2017 European Meeting
The MAP, Official Newsletter of ISMPP: http://ismpp-newsletter.com/2017/01/23/new-medical-writer-joint-position-statement-released-by-amwa-emwa-and-ismpp/
AMWA Journal: http://c.ymcdn.com/sites/www.amwa.org/resource/resmgr/journal/Spotlight/2017v32n1_JPS.pdf
EMWA Medical Writing: http://journal.emwa.org/writing-better/
MedComms Networking’s Brunch Club Event, April 5, 2017: http://www.networkpharma.tv/
You have probably heard someone say, “Politicians won’t listen to an average citizen.” Or perhaps something along the lines of, “Politicians just like to sit around and argue with each other – they’re completely ineffective.” Maybe you’ve even said these things yourself. After all, it’s accepted conventional wisdom that politicians are corrupt and government is broken.
In truth, the most common phrase you hear in any elected official’s office is, “what do my constituents think?” In other words, elected officials DO listen to people in their communities – and the conflicts within and among these communities account for much of the debate and acrimony demonstrated in a legislative organization.
This is exactly what the Congressional Management Foundation found in a recent study of Congressional staff. When asked what influences a legislative decision, a visit from a constituent was number one. Numbers two, three and four were other personalized communications from constituents, such as letters and phone calls. A visit from a lobbyist was number five.
Learn more about the study (and the power of citizens) by reading the Foundation’s "Communicating with Congress" Series.
Read on to learn how to use this power effectively!
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Why Should ISMPP Members Advocate?
From Sunshine Act regulations to questions about so-called “ghost-writing” to concerns about the engagement of pharmaceutical companies in the drafting of publications, the federal government impacts ISMPP members every day and in every way. Unfortunately, many members of Congress, agency officials and their staff have a very limited understanding of how the medical publications process works as well as, perhaps more important, the high ethical standards to which ISMPP members already agree. As such, policymaker opinions and actions are often based on negative perceptions of your role in the drug development and safety cycle.
Federal actions, whether the introduction and consideration of legislation or the development of federal regulations, can impact you positively or negatively – it’s all up to you! As a both a medical publications professional and a citizen, you can have a say in what happens in Washington, D.C.
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What if My Company Doesn’t Want Me to Advocate?
We recognize that many ISMPP members are associated with larger companies that may have policies regarding the involvement of their employees in political and advocacy activities. Be sure to investigate your situation, while keeping the following two principles in mind:
Sometimes your advocacy efforts will need to be internal to your company. In other words, you may need to spend some time convincing others of why advocacy is important and why the particular issues surrounding your work should receive attention. Many of the strategies outlined in these materials can and should be used in that context as well.
As a private citizen, you have every right to advocate on any issue of concern to you. If your company seems reluctant to let you participate as a company representative, consider how to advocate on these issues from a personal perspective. Your voice as an individual citizen matters!
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The Art of the “Ask”
Asking for something specific is sometimes the only way to get a policy maker’s attention. Your goal is to force someone in the office to think about you and your issues for longer than 5 minutes -- making the "ask" helps you achieve that goal. There are essentially two kinds of asks:
Policy “asks” are oriented around specific legislative or government initiatives (such as asking a member to support funding for the National Institutes of Health (NIH) research grants).
Relationship-building “asks” are things you ask for that aren’t necessarily policy-related, such as scheduling a meeting, but that may help you with policy “asks” in the future.
Currently, ISMPP’s most important priority is to ensure that legislators, agency officials and their staff have a better understanding of the role of medical publications professionals in the drug development process. To achieve this goal, we ask ISMPP members to focus on the following “relationship-building” asks:
Ask for a meeting with legislators in their local district office. You can find contact information for the local offices on your legislators’ home pages, which are accessible through the www.house.gov and www.senate.gov websites. Every legislator has staff people in those offices eager to make connections in their communities.
Ask your legislators’ D.C. offices for a brief phone appointment with a staff person who handles health care issues. You’ll be surprised at how accessible and friendly they are.
Ask legislators and their staff to support efforts to improve the federal partnership with medical publications professionals and to recognize your critical role in the drug development process. This may include encouraging them to have a better understanding of existing ethical standards, addressing the unique needs of medical publications professionals in drug development or supporting ongoing NIH research efforts.
Ask legislators and their staff to see you as a resource for any questions that may arise regarding the drug development process
ISMPP has put together a chart that can serve as a “one-pager” that will facilitate discussion with policymakers.
As the legislative and agency environment develops, ISMPP will reach out to its membership on specific policy-related asks.
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What Specific Legislative and Policy Issues Should ISMPP Members Understand?
Members of Congress and agency officials consider issues relating to the work of medical publications professionals on a periodic basis.
Past and current policy issues include:
“Ghostwriting”: Senator Grassley (R-IA) has expressed concern regarding the issue of “ghostwriting” in medical publications. You can learn more about his perspective here: http://www.grassley.senate.gov/about/upload/Senator-Grassley-Report.pdf. This issue has not yet been raised in the current legislative session, but given the fluidity of the federal environment it can come up at any time. This is why we need to develop relationships now – before there is a crisis!
Sunshine Act Regulations: As part of the Affordable Care Act, the Centers for Medicaid and Medicare Services (CMS) were directed to implement a system for reporting physician ownership or investment interests in those drugs, devices, etc. covered by federal insurance entities. The ISMPP Sunshine Act Taskforce has monitored these developments and provided information to its members regarding the impact on medical publications. We will continue to be engaged in these efforts as CMS implements these rules and as Congress continues to consider updates to the Affordable Care Act.
Transparency for Clinical Trials: Legislation has been introduced in the past designed to promote the registration of publications in the www.clinicaltrials.gov database. ISMPP continues to monitor these issues in terms of their impact on medical publications professionals.
Funding for NIH Research Grants: Research grants at the National Institutes of Health have continued to be scrutinized and reduced as part of the ongoing budget battles in Washington, D.C. ISMPP members may be called upon to voice their concerns regarding these cuts as events unfold.
As these policy issues develop, expect ISMPP to connect with you to ask for your engagement! We will provide specific details on talking points on the legislative environment and policy asks. You’ll have all the information you need to be effective in your communications.
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Know Your Elected Officials
Almost every citizen of the United States has two Senators and one House Representative (sorry territories and D.C., you have just one delegate!). The House members represent specific districts (there are 435 districts in the U.S.) and the Senators represent specific states (2 per state). Because they represent defined groups of people, elected officials and their staff must ask for your address so they know whether they represent you or not (and, if not, point you in the right direction). In some cases you’ll have different legislators representing where you live versus where you work. While you should start your advocacy with those who represent where you live, legislators care about all constituent connections. So it’s always a good idea to know who represents the district where you work as well. To be an effective advocate, there are a few things you should know about your elected officials:
Who are they?
Look up your Federal legislators via the links below:
What are their policy interests?
Check the “issues” tab on their website to assess their stance on the wide-variety of issues Congress considers. In addition, you can go to www.congress.gov to look up bills they’ve introduced.
What are their connections to medical publication issues?
Review their biographical information to see what schools they’ve gone to or the careers they’ve had. This is available at their websites or through www.votesmart.org
Resource: Legislator Profile Worksheet
This background information will help you craft messages that resonate with your legislators (discussed further in the “Tell Your Story” section below). For example, members interested in business issues will respond to arguments about the economic benefits of accurate and unambiguous medical publications. Legislators interested in healthcare issues will want to know more about the influence of medical publications on physicians’ prescription decisions.
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Tell Your Story
The SPIT Technique
You’ll want to “SPIT” out your advocacy message. SPIT is, of course, an acronym and stands for:
S = Specific in terms of what you want and what the audience wants
It is essential that you know what you want and be able and willing to ask for it. You should also look for ways to connect your “ask” to what the audience wants. Your research into the perspectives and interests of your audience will assist you.
P = Personal
You attract people to your cause through a compelling story. We know through a story that the thing we’re talking about has had, or will have, an impact on an actual human being. How has your work enhanced a published clinical research study? What were the clinical implications of the published study?
I = Informative
In addition to telling your personal story, you’ll want to wrap some facts and figures around your argument. The International Society for Medical Publication Professionals’ Good Publication Practice document can give you some valuable information
T = Timely
Clearly, contacting a decision maker AFTER a decision has been made rarely works. Your job is to build a relationship with them over time so that when the issue does come up, your specific ask is a “no brainer.”
Use the following message formula to pull all these elements together. You can use this in a meeting or convert to a written communication or phone call.
My name is and I’m from [establish relevance by clarifying that you are a constituent]
I am here to ask for [specific ask]
Knowing of your interest in [specific to the audience], I think you’ll be interested too
This is important to the people I represent because [personal story and information]
That’s why I hope you’ll [specific ask]
I’d like to follow-up by [date]. When can I get back to you?
Resource: 10 Tips for Effective Messages
This PowerPoint offers details you to deliver your message to a decision-maker.
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Seven Things to Do Today!
Learn about your legislators (see “Know Your Elected Officials”)
Find and follow legislators on Facebook, Twitter and YouTube.
Craft your personal story. What role do you play in the drug development process? Why is that important to you? How does it impact the people in the legislator’s district?
Learn about current issues and asks
Connect with legislators and staff at home during a town hall meeting. During what are known as Congressional recesses legislators and their staff are at home meeting with constituents. You can stop by a town hall meeting, learn more about the legislator’s interests, concerns and activities, and meet both the policymaker and his or her staff.
Write or email your elected representative using this Sample Letter to Elected Official as a resource.
Learn about the legislative process. Although you should never feel like you need to be an expert on “how a bill becomes a law”, if you’re interested in this topic you can learn more at http://beta.congress.gov/legislative-process
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