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 recent crisis over contaminated Chinese heparin has had a number of close examinations from two different Congressional panels in the last month. The inquiries into the crisis have revealed a critical impasse over the Food and Drug Administration’s current system of inspecting foreign-based factories and, to a greater degree, the ability of FDA to bolster that regime to meet the same requirements as domestic plants. Members of Congress are concerned that FDA is not inspecting foreign drug plants on roughly the same biennial schedule as domestic drug factories. Moreover, the House Energy & Commerce Chairman was very critical of the FDA’s budget request for foreign inspections in future years calling it insufficient to meet the vast number of facilities which are producing drugs and medical products for export to the American market. However, the FDA Commissioner said the agency’s current foreign-inspection system would not have prevented the heparin contamination and that FDA is moving ahead on improvements. (See more about this below in FDA Update).
To counter these perceived shortcomings in FDA’s drug safety effort, both the House and Senate are working on legislation designed to improve their operations and enhance the system. Rep. Dingell is perceived to be the prime mover in pushing for the legislation and committee aides indicate that House and Senate staffers are preparing to meet in the coming weeks to discuss a possible compromise measure which could pass both chambers and go directly to the White House. These “pre-conference” negotiations will likely include provisions on foreign-made drugs and medical devices as well as food imports which have also been the subject of recalls and health concerns in recent years.
ACRP will continue to monitor the progress of this legislation and will interact with key Members and Congressional staffers to continue our role in educating them about effects on clinical trials and on our membership.
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
The month of July will be critical to the fate of any drug safety legislation in this current Congress as it is the second to last full month that the House and Senate are likely to be in session prior to the November elections. As noted earlier, both the food and drug safety legislation are currently being pulled together to address the many concerns of elected officials about the Food and Drug Administration’s (FDA) operations and capabilities. According to staff familiar with the process, it is hoped that these bills can be readied for committee markups during this month and be readied for consideration by the House shortly.
However, at least two other legislative priorities for the House Energy & Commerce Committee stand in the way of the food and drug safety bills already. One is the reauthorization of the Animal Drug User Fee Act (ADUFA) which governs the use and fees paid by makers of pharmaceuticals for use on farm animals and pets. This legislation’s authorization runs out this year and, like last year’s FDA reauthorization, must be renewed to ensure that this vital funding stream remains available for FDA’s operations. Secondly, the Energy & Commerce Committee is also working on a package of health information technology (HIT) legislation which will help physicians to deploy modern computer and electronic records technology in their care of patients in order to improve the quality of care and avoid medical mistakes which harm and kill many Americans each year. The Committee has begun the markup sessions on the ADUFA bill and will continue to move ahead on the HIT issue. But with the month-long August recess quickly approaching, it is quite likely that the food and drug safety bills may slip into September and push up against Congress’s desired break to campaign for the last six weeks prior to the election on November 4.
ACRP 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.
Use the links below for all of your public policy needs: