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 five-week long Congressional recess arrived on August 1 and the fate of any drug safety legislation in this current Congress was still in doubt as the two chambers left Washington. As expected, the House Energy & Commerce Committee moved ahead on both of their priority measures prior to the recess – a reauthorization of the Animal Drug User Fee Act (ADUFA) and a package of health information technology legislation. However, they did not take up the draft measure on drug safety.
The Committee has begun very preliminary work on the food section but nothing on devices or cosmetics. There remains a remote possibility that the House might move just the drug safety title this year but most observers believe that it cannot be moved without a similar effort on food safety. As of this date Energy and Commerce has no further plans for hearings on the Food and Drug Administration set for the remainder of this Congress. The Senate is apparently not any further ahead. These facts point to the Congress not acting this year and a new, comprehensive measure to be crafted for introduction when the next Congress begins in January 2009.
ACRP and APPI will continue to monitor this very fluid and uncertain situation and advise on progress of relevant legislation as we continue working with key Members and Congressional staff to continue our role in educating them about effects on clinical trials and on our membership.
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