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ADVOCACY LETTERS

February 8, 2017: TAG and partner organizations advocating for the rights of people affected by HIV and TB around the world encouraged the President’s Emergency Plan for AIDS Relief (PEPFAR) to support the immediate introduction of the LAM test in all PEPFAR-funded countries and programs. The LAM test is a simple, useful diagnostic to detect TB in extremely vulnerable people with HIV.

December 19, 2016: TAG joined Filipino, regional, and global organizations in calling for the approval of new TB drug delamanid in the Republic of the Philippines. The letter sent to the Philippines Food and Drug Administration highlighted the importance of access to new TB treatment options like delamanid, pointing to the Philippines' high rates of drug-resistant TB. The letter also acknowledged the country's history of hosting the clinical trials that underpinned delamanid's approval by stringent regulatory authorities several years ago. 

December 19, 2016: TAG and other civil society and community groups sent an open letter encouraging the expert advisory board of the Global Antimicrobial Resistance and Innovation Fund (GAMRIF) to prioritize drug-resistant TB (DR-TB) in its research investments to combat AMR over the next five years. The letter points to the tremendous need and opportunity for new investors in TB R&D as DR-TB is the leading cause of AMR-related death.

November 25, 2016: TAG, in coalition with patient groups and other non-government organizations, issued an appeal to regulatory authorities during the 17th International Conference of Drug Regulatory Authorities in Cape Town, South Africa. This appeal urged governments to maintain stringent regulatory standards for new medicines, mandate publication of clinical trials data, and work towards regional regulatory harmonization. The statement was released in response to recent efforts to lower regulatory standards for marketing new medicines in the United States and Europe.

November 15, 2016: More than 200 organizations and individuals joined TAG in petitioning the leaders of Brazil, Russia, India, China, and South Africa (the BRICS nations), which host nearly half the global burden of TB, to increase investments in TB research. The petition followed the release of TAG's Report on Tuberculosis Research Funding Trends, 2005–2015: No Time to Lose, which showed that the world spent US$620.6 million on TB research and development (R&D) in 2015, the lowest level of funding since 2008, and that BRICS countries reported contributing only four percent of global funding for TB R&D. The petition encourages the BRICS health ministers to work within their governments to triple the amount of funding available for TB research.

November 16, 2016: TAG joined civil society partners from around the world in endorsing a statement urging the Global Fund to ensure that countries are able to maintain and expand their TB programs. The statement, which followed the 47th Union World Conference on Lung Health in Liverpool, responds to the risks posed by the Global Fund's new Sustainability, Transition, and Co-financing (STC) policy to the ability of countries to purchase quality and affordable medical commodities, including new TB drugs and diagnostics.

October 24, 2016: TAG, the TB CAB, and other civil society organizations, product development partnerships, care providers, and university programs, sent an open letter to the World Health Organization encouraging its leadership to establish and maintain a Model List of Essential Diagnostics.

October 20, 2016: TAG sent an open letter to the Global Fund encouraging the development of a policy for all countries to switch to the new pediatric formulation for first-line TB medicines, and coordinate procurement via the Global Drug Facility (GDF) to ensure maximal affordability, efficiency, and market stability.

September 12, 2016: TAG joined several domestic partner organizations in signing a letter led by the AIDS Budget and Appropriations Coalition calling for House and Senate appropriations committees to restore cuts to critical HIV and TB programs in their FY2017 Labor HHS Appropriation Bills.

August 24, 2016: In an open letter, TAG allied with activists, advocates, representatives of TB affected communities, researchers, clinicians, national TB program staff, and civil society and non-profit organizations, to appeal to the International Union Against Tuberculosis and Lung Disease to host its annual international conferences in countries with high burdens of TB and/ or lung disease to facilitate inclusion of affected communities and mobilize political will.

July 6, 2016: TAG and other U.S.-based civil society groups asked the House Subcommittee on State and Foreign Operations (SFOPS) to match the Senate's $5 million proposed increase to USAID's FY2017 TB program budget. The letter to the House SFOPS Chairman and Ranking Member describes the importance of the proposed funding increase to implement the National Action Plan to Combat Multi-Drug Resistant Tuberculosis and the need for more tools to counter the rise of drug-resistant TB.

June 13, 2016: TAG and other U.S.-based civil society groups responded to a $5 million cut to the U.S. Centers for Disease Control and Prevention's TB program budget proposed in a recent bill put forth by the Senate Labor, Health and Human Services, Education, and Related Agencies (L-HHS) Appropriations Subcommittee. In a letter to the Senate L-HHS Appropriations Subcommittee, TAG and other organizations allied in the fight against TB urged the subcommittee to restore the FY2016 funding level of $142.2 million for the Centers for Disease Control and Prevention’s (CDC) Division of TB Elimination to ensure the availability of resources necessary to implement the National Action Plan and prevent further erosion of our national, state and local TB programs.

May 25, 2016: TAG and other U.S.-based NGOs and civil society groups expressed support for medical and global health research conducted by the U.S. Department of Defense (DoD) in a letter sent to members of the Senate Appropriations Subcommittee on Defense. The letter urges the committee to continue to support DoD research programs vital to national and global health security by opposing provisions proposed in the Fiscal Year 2017 National Defense Authorization Act that would limit the DoD's ability to conduct critical research on infectious diseases.

May 31, 2016: In an open letter, TAG, the TB CAB and other organizations acknowledged Johns Hopkins University (JHU) for leadership in global health. The letter was sent following an announcement that the Medicines Patent Pool (MPP) is in negotiations for the rights to sutezolid with a "research-based university" (presumably JHU, which has rights to develop sutezolid in combination). This welcome news is the result of a months long, coalition based advocacy campaign led by Universities Allied for Essential Medicines (UAEM). JHU's decision to enter negotiations towards licensing the worldwide non-exclusive rights for sutezolid to the MPP is expected to help ensure sutezolid’s expeditious and appropriate clinical development in combination with other medicines, and its future accessibility and affordability for TB patients and treatment providers around the world.

May 19, 2016: TAG, along with other U.S.-based advocacy groups and nonprofit developers, reiterated the need for amendments to the Priority Review Voucher (PRV) program to ensure that it rewards truly new and accessible products. Signatories sent the letter requesting support for the addition of novelty and access requirements to the PRV program to leaders of the U.S. House of Representatives Committee on Energy and Commerce in advance of its hearing regarding Bill H.R. 3299, which proposes to expand the PRV program to include any disease or agent considered a material threat under the Public Health Service Act.

May 19, 2016: TAG and the TB CAB supported calls from The Delhi Network of Positive People and other Indian civil society members for the immediate rollout of daily fixed-dose combinations (FDCs) for drug-sensitive TB in India. Daily therapy is the standard of care around the world and is particularly important in people with HIV. The Revised National TB Control Program (RNTCP) announced the rollout of dailyFDCs in 104 districts and five states in India in December 2014, but still has not fulfilled this commitment. In a letter to the Ministry of Health & Family Welfare, signatories demanded strong political commitment to ensure the procurement and availability of daily FDCs for adults and children, and for the Ministry of Health to take further steps necessary for nationwide implementation.

March 29, 2016: TAG, along with other U.S.-based advocacy groups and nonprofit developers, called for amendments to the Priority Review Voucher (PRV) program to ensure that incentives reward truly novel, available, and affordable drugs. In its letter, sent to the U.S. House of Representatives Committee on Energy and Commerce Leadership as Congress considers the addition of Zika to the list of diseases eligible for a PRV from the U.S. Food and Drug Administration (FDA), TAG strongly recommends the addition of a novelty requirement and an access strategy to the PRV program. 

March 24, 2016: On World TB Day, the Sentinel Project, TAG, and 148 concerned individuals called on the World Health Organization (WHO) to update its 2014 guidance on new TB drug delamanid to include children. The signatories urged the WHO to rapidly update the guidelines in light of new evidence of delamanid's safety in children as young as six years old.

March 23, 2016: In advance of World TB Day, TAG and the TB CAB sent a letter to global health leaders regarding the appalling international response to the multidrug-resistant TB (MDR-TB) outbreak in Papua New Guinea. In parts of Papua New Guinea, over one percent of the general population has MDR-TB, yet the Western Pacific Region Green Light Committee (GLC), which is supposed to help countries scale up the response to MDR-TB, has contradicted World Health Organization guidance and recommended that Papua New Guinea not expand critical new options for diagnosing and treating MDR-TB. The letter calls for an urgent intervention to improve the support given to Papua New Guinea, the transparency of the GLC, and the quality of its technical assistance.

March 10, 2016: TAG supported South African and global community groups in requesting via an open letter that the South African Minister of Health introduce TB LAM antigen testing for people with advanced HIV in public hospitals. The LAM test is a very simple, low-tech, low-cost test that uses urine rather than sputum, and has been shown to reduce mortality in people with HIV with low immunity, who are at very high risk of TB and poor outcomes. Since November 2015, the World Health Organization has recommended the LAM test a preliminary test to rule in TB in people with HIV with CD4 counts below 100/mm3 or who are seriously ill, but national health departments have not yet made it available.

February/March 2016: TAG and other U.S.-based NGOs and civil society groups sent several appeals to legislators to prioritize tuberculosis (TB) in plans for fiscal year 2017 in line with the White House’s recently released National Action Plan for Combating Multidrug-Resistant Tuberculosis. Letters to three key House and Senate subcommittees—the Labor, Health and Human Services, Education, and Related Agencies Subcommittee, the Defense Subcommittee, and the Subcommittee on State, Foreign Operations, and Related Programs—called for:

  • $243 million in TB funding for the Centers for Disease Control and Prevention (House and Senate letters);
  • $400 million in funding for the U.S. Agency for International Development's global TB program (House and Senate letters);
  • the inclusion of TB under the Biomedical Advanced Research and Development Authority's new emerging infectious diseases program and its work to implement the National Action Plan for Combating Antibiotic-Resistant Bacteria (House and Senate letters); and
  • maintaining TB on the list of approved diseases for the Congressionally Directed Medical Research Program Peer Reviewed Medical Research Program, which allows for the Department of Defense to invest in TB research programs (Senate letter).

December 17, 2015: TAG and the TB CAB signed on to open letters to several manufacturers of U.S. Food and Drug Administration (FDA)-approved generic linezolid, including Pfizer, Teva, Glenmark, Alkem, Amneal, Macleods, Apotex, Hetero, and Sanofi urging the companies to register their respective linezolid products with the Medicines Control Council (MCC) in South Africa. Registration of additional linezolid products will address the existing effective market monopoly and extremely high prices that prevent linezolid from being offered to all patients who could benefit from its use in South Africa and countries like Swaziland that rely on the South African regulatory approval system. The co-signatories asked that following registration, companies provide linezolid at the price currently offered to country programs through the Global Drug Facility (GDF).

December 15, 2015: TAG, the TB CAB, CRAG, Community Partners (CP), and Women’s HIV Research Collaborative wrote a joint letter to the Director of the National Institutes of Allergy and Infectious Disease (NIAID) Division of AIDS (DAIDS) in support of the establishment of a TB registry for pregnant women. The letter underscores the essentiality of the registry to informing the safe treatment of pregnant women with TB in the absence of clinical trials data, and its complementarity to ongoing research by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) and the AIDS Clinical Trials Group (ACTG) to guide the prevention and treatment of TB in pregnant women.

November 23, 2015: TAG, with clinicians and healthcare workers, patients with drug-resistant tuberculosis (DR-TB), and other civil society organizations, followed up communication from October with the South African Office of the Registrar, urging the Medicines Control Council (MCC) to prioritize dossiers for generic linezolid, with a second letter. The follow up letter reiterates the importance of urgently registering further quality generic versions of linezolid in South Africa in order to improve its availability as part of treatment regimens for patients with DR-TB.

November 17, 2015: TAG, with Médecins Sans Frontières (MSF), the TB Alliance, the American Thoracic Society (ATS), the Drugs for Neglected Diseases initative (DNDi), and the Infectious Diseases Society of America (ISDA) Center for Global Health Policy, sent an open letter to the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP). The letter called attention to the need for amendments to the U.S. Food and Drug Administration (FDA) Priority Review Voucher (PRV) program for neglected diseases. The letter urges the HELP Committee to include amendments to the FDA PRV program in planned biomedical R&D legislation, including adding requirements on access and novelty to ensure that R&D for neglected diseases is appropriately incentivized, and that all patients in need can benefit from resulting biomedical innovations.

November 2, 2015: TAG signed on to an open letter to President Obama demonstrating support for the release of a National Action Plan to Combat Drug-Resistant TB (DR-TB), originally meant to accompany the National Action Plan for Combating Antibiotic Resistant Bacteria released in March. The letter urges the President to formally release the National Action Plan to Combat DR-TB and to submit a budget request to enable its implementation.

September 24, 2015: TAG, the TB CAB, and the SWIFT Response Project sent an open letter to the Philippines National TB Program (NTP) and Department of Health (DoH) congratulating them for moving forward the introduction of new treatment options for multi-drug resistant tuberculosis (MDR-TB), and urging them to ensure rapid delivery to people with MDR-TB. The letter encourages the NTP and DoH to ensure the initiation of patients on bedaquiline, the enrollment of consenting patients into their shortened treatment program, and the availability of delamanid in the Philippines.

September 15, 2015: TAG signed on to an open letter to India’s Minister of Health and Family Welfare calling for the immediate scale-up of GeneXpert machines and MTB/RIF cartridges, which are capable of detecting TB disease and rifampicin resistance in just two hours. The letter highlights critical delays in procurement of these machines and cartridges, underutilization of available machines, cartridge stock-outs, and lack of access to this technology for people living with HIV.

September 3, 2015: On behalf of TAG, the TB CAB, and other allied organizations and individuals, Universities Allied for Essential Medicines (UAEM) presented the president of the Johns Hopkins University with a petition calling for transparency and assurances of non-exclusivity as the university negotiates a licensing agreement for the promising TB drug sutezolid.

August 12, 2015: TAG signed on to an open letter calling for Indian health and municipal authorities to urgently address increasing rates of occupationally acquired TB at Sewri Hospital in Mumbai—Asia’s largest TB hospital. Inadequate infection control measures and access to personal protective equipment have left health care workers at Sewri Hospital without means to protect their health and safety. The letter outlines several measures that health and local authorities can take to better protect health care workers from TB.

August 10, 2015: TAG signed on to an open letter calling for the prioritization of human rights in The Global Plan to Stop TB, 2016–2020. The signatories outline international instruments that establish legal rights for people with TB and encourage members of the Global Plan Development Task Force to more fully integrate a clearly developed human rights–based approach into the Global Plan.

July 28, 2015: TAG signed on to an open letter to President Obama in support of his decision to develop a National Action Plan to Combat Drug-Resistant TB (DR-TB). The letter advocated for the future plan to include bold targets for scaling up services for addressing DR-TB globally and in the U.S., an aggressive research agenda, and funding necessary for implementation.

May 7, 2015: TAG and the TB CAB sent an open letter urging the Johns Hopkins University to assure the timely and responsible development of new TB drug sutezolid when transferring its intellectual property rights to Sequella. The letter points to Johns Hopkins’s ability to ensure that sutezolid is advanced rapidly, including in combination with other potential new drugs, and that is it made widely available and affordable pending results of the drug’s performance in clinical trials.

May 5, 2015: TAG and the TB CAB sent an open letter to the Global Plan Development Task Force reiterating the need for inclusion of evidence-based and ambitious programmatic and R&D funding targets in the Global Plan to Stop TB, 2016–2020.

March 24, 2015: TAG and members of the global community working to end childhood TB sent an open letter encouraging the World Health Organization to track the number of children screened for, started on, and completing TB preventive therapy. The World Health Organization’s response indicated willingness and plans to do so. TAG and partners then requested specific additions to the proposed priority list of indicators related to the monitoring and evaluation of screening and treatment for TB infection in children.

March 10, 2015: TAG signed on to an open letter to the International Union Against Tuberculosis and Lung Disease (the Union) calling for an end to the use of stigmatizing and criminalizing language in TB research and practice. José Luis Castro, executive director of the Union, responded with a commitment from the Union to include language guidance in the abstract review process for its conferences and explore similar guidance for submissions to its two academic journals.

March 10, 2015: TAG signed an open letter to the WHO and other key global health agencies and organizations calling for accelerated and coordinated action to ensure access to new and repurposed TB drugs.

March 2, 2015: TAG sent an open letter to the Global Plan Development Task Force urging the inclusion of pediatric-specific program interventions and research funding targets in the Global Plan to Stop TB, 2016–2020.

January 31, 2015: To encourage more equitable access to new and repurposed TB drugs, TAG signed on to letters of support for the inclusion of rifapentine, bedaquiline, delamanid, and linezolid on the WHO's Model List of Essential Medicines. The 20th Expert Committee on the Selection and Use of Essential Medicines will review drug applications and public comments in April 2015. 

December 11, 2014: In further efforts to improve access to linezolid for people with drug-resistant TB in need throughout South Africa, TAG signed on to an open letter to inform medical schemes in South Africa of their duty to cover linezolid for drug-resistant TB. The letter, signed by forty organizations and individual experts, gives an overview of TB—the leading cause of death in South Africa—and explains the importance of linezolid for treating drug-resistant strains of the disease. The letter also presents the legal duty of schemes to cover treatment with linezolid, and requests that each scheme provide in writing its policy on providing coverage for linezolid, and refund any amounts paid out-of-pocket for linezolid by its members previously denied coverage.

October 20, 2014: TAG signed on to an open letter to the Medicines Control Council, urging them to register a generic version of linezolid to make it available for all patients with drug-resistant TB in need throughout South Africa. Brand-name linezolid is exorbitantly expensive, and out of reach of most people who need this potentially life-saving antibiotic. Without access to this quality-assured generic version of linezolid, many patients with difficult to treat forms of TB are denied treatment. See press coverage on the letter.

October 8, 2014: TAG signed on to an open letter from civil society organizations and individuals to express concern over the administration of scholarships for the 45th Union World Conference on Lung Health. The Union's poor execution of free registrations involved inappropriate selection criteria, giving too few free registrations, and offering no support for other costs associated with attendance, and was concluded too late to enable recipients to organize logistics to attend. As such, representatives of TB-affected communities are effectively excluded from this year's conference, which is themed  “Community-Driven Solutions for the Next Generation." TAG and other signatories requested to meet in person with Union leadership to resolve these issues.

September 10, 2014: TAG and a coalition of organizations and individuals working on TB sent an open letter to Janssen appealing to the company to lower bedaquiline's price for all non-high-income countries. They also requested a September 2014 meeting with the company, policy makers, and key funders of TB drug procurement to make bedaquiline accessible affordably.

March 12, 2014: TAG, CRAG, the TB CAB, other leading advocacy groups, doctors, and medical organizations send open letter to Otsuka to voice concerns regarding access to delamanid.

February 13, 2014: TAG, CRAG, and the TB CAB send open letter to AstraZeneca urging their continued investment in tuberculosis research despite the cessation of AstraZeneca’s Neglected Tropical Diseases, Tuberculosis and Malaria program.

January 6, 2014: TAG and the TB CAB send an open letter to Cepheid requesting they: further reduce the price of Xpert MTB/RIF cartridges and decrease the price of GeneXpert MTB/RIF machines, given the large volumes already purchased and large projections for 2014 purchasing as a result of the WHO policy update, which recommends the GeneXpert MTB/RIF for use as the initial TB test in adults with presumed TB; provide extended machine warranties free of charge; and address barriers to public sector procurement of cartridges and machines at the negotiated concessional prices in Russia and China.

January 2, 2014: TAG submits a public comment regarding FDA docket No. FDA-2011-N-0898, “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biologic Products” advocating for the FDA rule under the FDA Safety and Innovation Act (FDASIA) to be revised to better empower the FDA to address domestic TB drug and biologics shortages and stock-outs.

December 4, 2013: TAG, CRAG, and the TB CAB issues urgent appeal for Otsuka to initiate its long overdue compassionate use program by the end of 2013. 

August 6, 2013: TAG and TB CAB issue open letter to Alere regarding responsible marketing and access plans for Alere’s Determine TB-LAM antigen test for active TB among people with HIV with severe immunosuppression.

July 22, 2013: TAG and TB CAB issue open letter to Sequella on further research into sutezolid, a new drug under development for tuberculosis

July 2, 2013: TAG, TB CAB and India CAB issue open letter to Immunoshop re: marketing and use of TB Platinum test, which is inappropriately being used to diagnose active TB in India and high TB burden countries.

July 1, 2013: TAG and other leading advocacy groups, TB clinicians, controllers, researchers, and medical organizations write an open letter to Sanofi to request that the U.S. public price of rifapentine be lowered from $51 per box to $35 per box, and that Sanofi commit to further funding to complement the tremendous public resources invested in rifapentine’s development.

May 23, 2013: TAG, the American Thoracic Society, and the Infectious Diseases Society of America send letter to the Subcommittee on Labor, Health and Human Services of the Senate Appropriations Committee regarding the effect of sequestration cuts on TB research and care as part of the Save TBTC campaign.

May 14, 2013: TAG, TB CAB, and India CAB issue open letter to Qiagen on the inappropriate marketing and use of QuantiFERON-TB Gold for active TB in India and high TB burden countries [Qiagen response from May 18, 2013 available here].

March 14, 2013: Following the U.S. Food and Drug Administration’s approval of bedaquiline for the treatment of drug-resistant TB (DR-TB), TAG and the TB CAB sent an open letter to Janssen asking the company to determine a fair price for the drug. The letter notes the importance of affordability, both in the low- and middle-income countries that disproportionately bear the burden of TB, and in low-incidence settings such as the United States where fiscal austerity leaves TB programs with few resources. The letter also asks Janssen to expedite the conduct of further research necessary to determine bedaquiline’s safety and optimal use.

May 24, 2012: TAG and TB CAB issue an open letter to Janssen, bedaquiline’s sponsor, about the need to accelerate pediatric research, to determine the safety of using bedaquiline and delamanid together, and to support Janssen’s compassionate use program to provide access to bedaquiline for people in urgent need in places where the drug has not yet been approved.

May 24, 2012: TAG and the TB CAB send open letter to Otsuka to expedite plans to develop a pre-approval access program for delamanid for patients in urgent need, determine if delamanid is safe to use with bedaquiline, and develop the drug for pediatric use as rapidly and safely as possible.

May 24, 2012: TAG and TB CAB send letter to FDA and  to the EMA to encourage crucial regulatory harmonization on endpoints for tuberculosis drug development, and to encourage Otsuka and Janssen to conduct necessary drug-drug interaction studies on bedaquiline and delamanid.

April 16, 2012: TAG and the TB CAB send open letter to Cepheid calling for price reduction for the GeneXpert machines and the Xpert MTB/RIF cartridges.

April 11, 2012: TAG and the TB CAB support South African advocates, doctors, and organizations in their call for early access to bedaquiline by sending an open letter to the South African Medicines Control Council (MCC).