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Recommendations to the Food and Drug Administration

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Recommendations to the Food and Drug Administration RECOMMENDATIONS TO THE FOOD AND DRUG ADMINISTRATION FROM THE NATIONAL BLACK CHURCH INITIATIVE July 5, 2017 Honorable Dr. Scott Gottlieb, M.D. Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Through: Church of God in Christ African Methodist Episcopal Church African Methodist Episcopal Zion Church Christian Methodist Episcopal Church Full Gospel Baptist Church Fellowship International National Baptist Convention, USA, Inc. National Baptist Convention of America, Inc. Progressive National Baptist Convention, Inc. Pentecostal Assemblies of the World, Inc. The Union of Black Episcopalians National Council of Churches International Council of Community Churches Unity Fellowship Church Movement Mount Calvary Holy Churches of America Greater Mount Calvary Holy Church American Baptist Churches Berean Missionary Baptist Church The Potter’s House Dear Honorable Dr.Gottlieb, Congratulations on your appointment as the Commissioner of the FDA. We are extremely pleased that you are willing to meet with us and consider recommendations of increasing African Americans in clinical trials. Let us pledge our entire support of 34,000 Black Churches behind your agenda during your tenure. We are committed to helping to produce safe and effective drugs, nutritious and disease-free food, and innovation in the process of these two industries that are now under your regulatory control. We are committed to making your tenure the most successful in the history of the FDA. Five years ago, the National Black Church Initiative Board and Denominational Leadership decided we needed to be a part of the coalition to improve our nation’s health after the passing of the Affordable Care Act. We had a brainstorming session three years ago about what our approach would be in this endeavor. One of the first steps that we decided on was to tackle the regulatory issues surrounding the ACA to ensure on a regulatory level that African Americans were being treated fairly and equally, which we have a moral and constitutional right to and to create an environment and processes towards increasing African American access to care. We have worked with numerous policy groups around Washington, including PhRMA to make sure that the regulations that were being written were balanced and driven solely by hard science and not economics. We also worked with pharmaceutical companies to create a comprehensive initiative to improve the participatory level of African Americans in clinical trials and bioresearch. We first sought to work with pharmaceuticals on the issue of the Affordable Care Act only to be rebuffed by the industry. So, we gathered again and offered a major push towards clinical trials using the full weight and might of our 34,000 churches and 15.7 million congregants. We wrote the Honorable Francis Collins a letter inquiring about the nature of what the government was doing around the NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research. We were then sent a cursory letter of no substance and felt that again we were being rebuffed by our own government inquiring about a regulation that they themselves created. You can imagine the deep frustration that 34,000 clergy felt at that time. We also wrote a letter to President Trump about extorting the value and the benefits of clinical trials and research. At the same time we wrote to PhRMA on February 4th endorsing their bold initiative of explaining to the American public the value of research and drug intervention. Again, we are sad to report that we never got a written response from PhRMA and felt rebuffed by getting a call from a low-aid who felt as though they were not taking this initiative as serious as we had presented it. Recently we wrote PhRMA again, telling them about our deep disappointment. Considering the pushback, we have reached out to the Food and Drug Administration and we were hoping to work with you through regulations to compel the pharmaceutical industry to address the issues we set forth in the letter to the Honorable Francis Collins. We look forward to future discussions with you and speaking in depth on how we can finally get this done after 25 years of deep frustration from 15.7 million African Americans who are citizens of this great country. We initially sent a letter to the Honorable Francis Collins but never received a letter from him, though we did receive a letter from the Office of Minority Health which was insulting to 15.7 million African Americans who are trying to improve their health. They believe that a simple letter is sufficient from a community who struggles under the weight of health disparities. We do not. Through its innovative Clinical Trial Education Awareness Participation Program (CTEAPP), NBCI could be an answer to the industry’s perplexing problem. “Despite advances in literacy and education as well as major improvements in communication…in this period of unprecedented acceleration in the pace of scientific and technological advances, and the educational focus on Science, Technology, Engineering and Mathematics (STEM)…there will still be a great gap between medical (protective) knowledge and the public acceptance of it.” - Bailus Walker PhD, MPH The healthcare industry has a major problem, but neither the pharmaceutical industry nor the other major players in healthcare are not going to do anything about this problem until they are compelled by strong regulatory from the FDA. We are willing to work in a regulatory position or a substantive partnership to achieve the goals of these recommendations. Let us make it very clear that the National Black Church Initiative is not going away. We will prosecute this issue across the proper channels and through the public if necessary. We should set up a meeting with the Chair of the oversight appropriation committee to drive home this point so we can refer to the meeting in this letter. Sincerely, Rev. Anthony Evans President CC: Dr. James E.K. Hildreth, Ph.D., M.D. President & Chief Executive Officer Meharry Medical College 1005 Dr. D.B. Todd, Jr. Blvd. Nashville, Tennessee 37208 Dr. Deborah B. Prothrow-Stith, M.D. Dean Charles R. Drew University College of Medicine 1731 E. 120th Street, Cobb 109 Los Angeles, CA 90059 Dr. Valerie Montgomery Rice, M.D., F.A.C.O.G. President & Dean Morehouse School of Medicine 720 Westview Drive Atlanta, GA 30310 Dr. Hugh E. Mighty, M.D., M.B.A., F.A.C.O.G. Dean Howard University College of Medicine 520 W St., NW. Washington, D.C. 20059 July 5, 2017 Honorable Dr. Scott Gottlieb, M.D. Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Through: Church of God in Christ African Methodist Episcopal Church African Methodist Episcopal Zion Church Christian Methodist Episcopal Church Full Gospel Baptist Church Fellowship International National Baptist Convention, USA, Inc. National Baptist Convention of America, Inc. Progressive National Baptist Convention, Inc. Pentecostal Assemblies of the World, Inc. The Union of Black Episcopalians National Council of Churches International Council of Community Churches Unity Fellowship Church Movement Mount Calvary Holy Churches of America Greater Mount Calvary Holy Church American Baptist Churches Berean Missionary Baptist Church The Potter’s House Dear Honorable Dr.Gottlieb, Congratulations on your appointment as the Commissioner of the FDA. We are extremely pleased that you are willing to meet with us and consider recommendations of increasing African Americans in clinical trials. Let us pledge our entire support of 34,000 Black Churches behind your agenda during your tenure. We are committed to helping to produce safe and effective drugs, nutritious and disease-free food, and innovation in the process of these two industries that are now under your regulatory control. We are committed to making your tenure the most successful in the history of the FDA. Five years ago, the National Black Church Initiative Board and Denominational Leadership decided we needed to be a part of the coalition to improve our nation’s health after the passing of the Affordable Care Act. We had a brainstorming session three years ago about what our approach would be in this endeavor. One of the first steps that we decided on was to tackle the regulatory issues surrounding the ACA to ensure on a regulatory level that African Americans were being treated fairly and equally, which we have a moral and constitutional right to and to create an environment and processes towards increasing African American access to care. We have worked with numerous policy groups around Washington, including PhRMA to make sure that the regulations that were being written were balanced and driven solely by hard science and not economics. We also worked with pharmaceutical companies to create a comprehensive initiative to improve the participatory level of African Americans in clinical trials and bioresearch. We first sought to work with pharmaceuticals on the issue of the Affordable Care Act only to be rebuffed by the industry. So, we gathered again and offered a major push towards clinical trials using the full weight and might of our 34,000 churches and 15.7 million congregants. We wrote the Honorable Francis Collins a letter inquiring about the nature of what the government was doing around the NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research. We were then sent a cursory letter of no substance and felt that again we were being rebuffed by our own government inquiring about a regulation that they themselves created. You can imagine the deep frustration that 34,000 clergy felt at that time. We also wrote a letter to President Trump about extorting the value and the benefits of clinical trials and research.
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