Public Policy
APPI, ACRP Launch Grassroots Campaign to Honor Patient Participants in Clinical Trials
APPI and ACRP have launched a campaign to support a federal effort to honor patient participants in clinical trials. The effort is embodied in U.S. House of Representatives Resolution 248, introduced by Congressman Rick Boucher, which encourages public recognition of clinical trial participants and focuses on the importance of educating the public on the many facets of clinical research in the advancement of medicine and what is entailed in study participation. APPI and ACRP staff has met with Congressman Boucher’s office to offer support for the resolution and to offer APPI and ACRP members’ help in contacting their own U.S. Representatives to urge them to cosponsor the resolution.
How You Can Help
Help recognize the contributions of the millions of men, women and children who participate in nearly 80,000 clinical trials in the United Stated every year. Do your part by urging your Congressional Representative to take action by co-sponsoring Resolution 248. Here’s how:
- Visit the U.S. House of Representatives website at www.house.gov and click on “Write your Representative” in the upper left section.
- Enter the requested information, including your ZIP+4 code, and click “Contact My Representative.”
- When prompted, please write a message. We have provided you a template to use here. Don't forget to personalize this message to create more impact.
- Once your email is sent, please provide a copy of the text and your representative’s name to ACRP staff at kate@acrpnet.org so we may follow up with the contact.
Should you have any questions regarding this campaign, please contact Katherine L. Madigan, MHSA, director of ACRP Government Affairs and managing director of APPI.
Academy of Pharmaceutical Physicians & Investigators Policy Proposal Opportunity
One of the high points of the APPI Program at the ACRP Global Conference & Exhibition each year is the "formal" (in name only) meeting of the members. This year’s meeting during our Boston gathering will be on Saturday, April 26, in the Hynes Auditorium, Room HH 202, from noon to 1:15 p.m. During the meeting, we will conduct an Annual Policy Forum, in which we present and gain comment on public policy proposals from you, the APPI membership. What positions would you like to see APPI weigh in on, either in a public arena (such as comment on legislation or regulations or other matters of current public debate) or with the American Medical Association (AMA) in preparation for its House of Delegates resolution process? To get a matter before our APPI leadership, please send us your thoughts, using freehand or the attached form, describing the policy issue you feel we should address, your rationale for suggesting that APPI get involved (or the resolution you feel we should submit to AMA, and why), and of course the position you feel we should take. You should also include some background, facts at hand, references, best arguments, etc. Of course, it would be best if you could be at the session yourself to make the argument, but if you can't, we'll present it on your behalf. So let us know how to reach you to be sure we can represent your concerns accurately. Please fill out the Policy Proposal Form and send it to APPIcomments@acrpnet.org by Friday, April 25.
Congressional Update
The growing concerns about the safety and efficacy of foreign-made pharmaceuticals has increased in recent weeks with the unfolding Chinese heparin contamination scandal that has resulted in four deaths and hundreds of adverse reactions in consumers. Members of Congress are understandably concerned about the situation and have moved to examine both the overall issue and this particular incident. Staff members at the House Energy & Commerce Committee confirm that the leaders of the Committee are working on the issue and are now focused upon the Food and Drug Import Safety Act of 2007 sponsored by Rep. John Dingell (D-MI). The bill, as it exists, would amend the Federal Food, Drug, and Cosmetic Act to require new fees on imported food and drugs, additional research on the development of tests and sampling methodologies for use on imported food, and would deem a food, drug, or device to be misbranded if its labeling fails to identify its country of origin. This bill could serve as a vehicle for additional efforts to strengthen drug safety and prevent repeats of these incidents.
However, it is important to note that many in Congress, on both sides of the aisle, are very critical of the current administration’s efforts in this arena and believe that much more must be done by the federal government to properly carry out its regulatory role. As noted below, a recent hearing resulted in statements by key Congressmen that FDA’s actions in the past have cast doubt on the entire drug approval process. In this heated environment where a great deal of press attention is focused upon a problem, the chance for legislative and/or regulatory action increases as well as the chance for unintended consequences. We will continue to monitor this fluid situation to keep members abreast of the latest developments.
Use the links below for all of your public policy needs:
APPI, ACRP Launch Grassroots Campaign to Honor Patient Participants in Clinical Trials
APPI and ACRP have launched a campaign to support a federal effort to honor patient participants in clinical trials. The effort is embodied in U.S. House of Representatives Resolution 248, introduced by Congressman Rick Boucher, which encourages public recognition of clinical trial participants and focuses on the importance of educating the public on the many facets of clinical research in the advancement of medicine and what is entailed in study participation. APPI and ACRP staff has met with Congressman Boucher’s office to offer support for the resolution and to offer APPI and ACRP members’ help in contacting their own U.S. Representatives to urge them to cosponsor the resolution.
How You Can Help
Help recognize the contributions of the millions of men, women and children who participate in nearly 80,000 clinical trials in the United Stated every year. Do your part by urging your Congressional Representative to take action by co-sponsoring Resolution 248. Here’s how:
- Visit the U.S. House of Representatives website at www.house.gov and click on “Write your Representative” in the upper left section.
- Enter the requested information, including your ZIP+4 code, and click “Contact My Representative.”
- When prompted, please write a message. We have provided you a template to use here. Don't forget to personalize this message to create more impact.
- Once your email is sent, please provide a copy of the text and your representative’s name to ACRP staff at kate@acrpnet.org so we may follow up with the contact.
Should you have any questions regarding this campaign, please contact Katherine L. Madigan, MHSA, director of ACRP Government Affairs and managing director of APPI.
Congressional Update
One of ACRP’s efforts in 2008 has been to grow support for a resolution in the United States House of Representatives which would honor the contributions of patients who participate in clinical trials. The measure, House Resolution 248, was introduced by Rep. Rick Boucher (D-VA) in March 2007 and had just two cosponsors and additional cosponsors were needed to move the resolution forward. To that end, ACRP’s Director of Government Affairs Katherine Madigan met with representatives of Congressman Boucher’s office last December to offer support for the resolution and to offer the Academy’s help in contacting their own U.S. Representatives to urge them to cosponsor the resolution. The ACRP/APPI cosponsorship campaign started in February 2008 and, along with actions by Rep. Boucher’s staff has already had some positive results. As of April 10, the resolution now has nine cosponsors and interest is growing.
However, additional cosponsors are still needed to get the measure out of the House Energy & Commerce Committee and to a vote prior to the end of the 110th Congress. A recent discussion with Rep. Boucher’s staff revealed that the Members of the House Energy & Commerce Committee are especially needed on the resolution. All ACRP and APPI members who are interested in supporting the resolution should contact their Member of Congress today. For more information on how to support this effort, please visit http://acrpnet.org/MainMenuCategory/PublicPolicy.aspx to receive materials related to contacting your Representative. We will continue to monitor the resolution and will advise of any new developments in this newsletter.
Use the links below for all of your public policy needs: