Written Senate Testimony for FY 2020 for the CDC’s Domestic TB Elimination Program and Division of Global HIV and TB
June 10, 2019 — This written testimony for Fiscal Year 2020 for the U.S. Centers for Disease Control and Prevention’s (CDC) domestic TB elimination program (DTBE) and the Division of Global HIV and TB (DGHT) was submitted to the U.S. Senate Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee.

TAG Testimony to the FDA on New Drug Application for Pretomanid Tablets
June 7, 2019 — TAG submitted testimony to the U.S. Food and Drug Administration (FDA) and the Antimicrobial Drugs Advisory Committee on New Drug Application (NDA) 212862 for pretomanid, proposed as part of a combination regimen with bedaquiline and linezolid (the Nix-TB regimen) in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB). Pretomanid is the first TB drug developed by a non-profit organization. In its remarks, TAG asks the Antimicrobial Drugs Advisory Committee to consider a number of critical questions regarding the efficacy and safety of pretomanid and the Nix-TB regimen, and suggests further research. TAG also asks the FDA and Antimicrobial Drugs Advisory Committee to ensure that the trade the FDA would be making in approving pretomanid—one of scientific rigor for efficiency in the face of serious unmet medical need—will not set a precedent that lowers the evidentiary standard for future TB drug and drug regimen approvals, thereby doing a disservice to the interests of TB patients in the future.

Follow-Up Letter: Serious Concerns RE: Errors in the WHO Guidelines for the Treatment of Drug-Resistant TB
June 5, 2019 — TAG and the other allied civil society organizations who sent the original letter (below) didn’t receive an adequte response to our original letter, so on June 5 we sent a follow up to Dr. Tedros Adhanom Ghebreyesus.

TAG Submitted Testimony to the House Committee on Oversight and Reform Hearing on “HIV Prevention Drug: Billions in Corporate Profits After Millions in Taxpayer Investments”
May 16, 2019 — TAG submitted testimony for the record for the hearing, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” at the request of members of the House Oversight and Reform Committee.

TAG Comments in Response to Proposed Rulemaking on Basic Health Program
May 2, 2019 — TAG sent these comments to Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services, regarding a proposed funding change to the Basic Health Program (BHP). Under the Affordable Care Act, the BHP has been crucial, as it’s allowed New York state to develop its “Essential Plan.” This option offers quality and affordable healthcare coverage to low-income New Yorkers who narrowly fall short of meeting the Medicaid income eligibility requirements. As stated in the comment, “TAG is also gravely concerned that this proposed rule, released in April 2019, would affect program funding for calendar year 2019, in violation of CMS’s requirements regarding timing of proposed rules and program years affected.”

Letter Addressing the Global Health and Human Rights Crisis Among People Who Use Drugs
May 1, 2019 — While civil society and global experts attended the 26th International Harm Reduction Conference in Portugal, 329 nonprofit organizations – including TAG – called on the international community to address the ongoing global health and human rights crisis among people who use drugs. Without a major shift in the global health response, the 2030 Sustainable Development Goals (SDGs) to promote good health and well-being, reduce inequalities, and provide access to justice for all won’t be met.

Letter Addressing Conflict of Interest Created by J&J Donations of Bedaquiline in India
April 29, 2019 — TAG is one of the signatories on this April 29, 2019 civil society letter that was sent to India’s Ministry of Health and Family Welfare concerning Johnson & Johnson’s ad-hoc donations of the TB drug bedaquiline – a very important new drug in the treatment of MDR-TB. As the letter states, “The donations of BDQ to India not only create dependence on donations from a single supplier but also stifle the Government’s willingness to promote local production of BDQ by generic manufacturers to ensure affordable, sustainable and predictable supply to the Government program.”

Advocates Raise Serious Concerns About Errors in the WHO Guidelines for the Treatment of Drug-Resistant TB
April 26, 2019 — On April 23, 2019, TAG and allied civil society organizations sent an open letter to Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), raising shared concerns about urgent and specific technical errors in the WHO consolidated guidelines on drug resistant tuberculosis treatment released in March 2019. In the letter, TAG, Médecins sans Frontières, Partners in Health, Global Tuberculosis Community Advisory Board, Drug-Resistant TB Scale-Up Treatment Action Team, and the Sentinel Project on Pediatric Drug-Resistant Tuberculosis requested immediate action and correction, and improvements to the WHO guideline development process to mitigate errors in the future.

Letter to FDA Regarding Application for Descovy as Pre-Exposure Prophylaxis for HIV
April 16, 2019 — TAG and PrEP4All sent this letter to Dr. Debra Birnkrant of the FDA, outlining and expressing our serious concerns about Gilead’s supplemental New Drug Application for Descovy (FTC/TAF) as HIV-1 preexposure prophylaxis (PrEP). There are several specific recommendations in the letter for this approval process, including recomending that the FDA convene a public meeting of the Antiviral Drug Advisory Committee.

Written Testimony for FY 2020 for the CDC’s Domestic TB Elimination Program
April 8, 2019 — This written testimony for Fiscal Year 2020 for the U.S. Centers for Disease Control and Prevention’s (CDC) domestic TB elimination program was submitted to the U.S. House of Representatives Labor, Health and Human Services, and Education (LHHS) Subcommittee. The testimony was submitted on behalf of the Tuberculosis Roundtable by representatives from the American Thoracic Society, the National Tuberculosis Controllers Association, RESULTS, Treatment Action Group, and We Are TB.