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No. 1, 2014

Solving the Silent Crisis: High-Level Working Meeting to Resolve and Prevent Domestic TB Drug Shortages

Introduction


Progress in eliminating TB as a public health problem in the United States is threatened by decreasing funding and by increasing problems in accessing life-saving drugs and diagnostics. A year after Treatment Action Group (TAG) and partners first convened a broad consultation on January 18, 2013, to discuss the U.S. and global TB drug shortage crisis, domestic shortages of TB products have persisted and possibly worsened. Thus, the National TB Controllers Association (NTCA), TAG, and partners determined there was a need for a follow-up, high-level meeting to find inter-agency solutions to the ongoing crisis of supply interruptions of TB drug and diagnostic products.

On January 15, 2014, TAG, NTCA, and PATH convened a small working group to explore potential solutions for more effectively preventing and responding to drug shortages. Included at this meeting were representatives from the following organizations:

  • CDC, Division of Tuberculosis Elimination
  • FDA, Center for Drug Evaluation and Research Drug Shortage Program
  • TAG
  • NTCA
  • Infectious Diseases Society of America (IDSA)
  • American Thoracic Society (ATS)
  • Community Research Advisors Group (CRAG)
  • Global Drug Facility (GDF)
  • RESULTS
  • Association of State and Territorial Health Officers (ASTHO)
  • Biomedical Advanced Research and Development Authority (BARDA)

Of note, the causes of the recent shortages of TB drugs and biologics are diverse, and vary based on manufacturer and product. This complicates the ability to intervene with a single solution. Some manufacturers report that compromises in the sterility of the production process contributed to the shortage. Others indicate that a lack of quality in some of the active pharmaceutical ingredients used in the product forced shutdown of the production of the product. Still others indicate that a higher demand than supply resulted in the need to allocate existing supply, leading to shortages. However diverse the causes, the outcome for TB control is consistent: we are left without the tools we rely on to both detect and treat infection and disease.

Findings and recommendations from the discussions


The group discussed a wide-ranging set of potential solutions, examining the merits of each, identifying barriers to overcome, and determining next steps. Lead interventions focused around the following:

  1. Creating a rotating, vendor-managed inventory (VMI) reserve
    A VMI option was agreed to be a good short- to medium-term solution for responding to acute shortages. Since most individual states lack the volume of cases and resources to create functional individual stockpiles, it was agreed that a national system would be the only realistic solution, and it would probably save money by eliminating redundancy of efforts. The main challenge anticipated is to determine resources, as well as the specific criteria under which reserves could be used.
  2. Centralizing procurement
    The group suggested that in the long term, centralizing procurement could streamline it for programs and facilitate supply predictions for manufacturers, and would create pooled demand and better communications. At the global level, this pooled procurement model is exemplified by GDF, and most participants felt that the U.S. should attempt to procure through GDF, as well, if regulatory hurdles could be overcome, especially because GDF is funded primarily via the U.S. Agency for International Development (USAID). Even if U.S. programs were able to procure drugs through GDF, the consensus was that a centralized system for managing requests and communicating information would still be necessary. This could take the form of a hybrid model (one in which procurements were national, but payment and distribution were regional) or a fully centralized model (in which a U.S.-GDF procurement system would be created). The main challenges expected are limited resources and a location for the system.
  3. Expanding the pool of U.S. suppliers
    Discussions focused on potential mechanisms for stimulating the U.S. registration of existing quality-assured sources of TB products. These included potentially receiving fast-track review status (following the PEPFAR precedent), waiving or finding incentives to counteract user fees, leveraging GDF relationships, and providing technical assistance to manufacturers to facilitate registration. These options are potentially challenged by regulatory inflexibilities or difficulties identifying resources to create incentives for costly and time-consuming FDA registration.
  4. Expanding markets to maintain existing U.S. suppliers
    In addition to encouraging the registration of GDF manufacturers in the United States, the group discussed the potential to encourage current U.S.-approved manufacturers to supply to GDF and benefit from the much larger global market for quality-assured medicines to which the GDF provides access. This larger global market could encourage continued manufacturing for existing suppliers through increased stability and volume.
  5. Improving communications
    When developing a centralized system or alternative solution, the group felt an improved communication infrastructure should also be developed to ensure that stakeholders can receive and provide up-to-date information about shortages. The GDF system was considered an example for adaptation, although it was recognized that a U.S.-specific system would be needed.

Next steps

As a way to extend the discussion and work towards implementation of the solution, five concrete steps were selected:

  • Create a rotating, vendor-managed inventory reserve
  • Centralize procurement
  • Expand the pool of U.S. suppliers
  • Expand markets to maintain existing U.S. suppliers
  • Implement cross-cutting approaches

The group agreed that additional meetings would probably be necessary to advance progress, detail action plans, and bring in important stakeholders who were not included in this preliminary meeting (e.g., representatives from the pharmaceutical industry). Progress on this important work, including decision-making about the most viable options and success towards addressing potential barriers, will be provided to TB Notes and posted on the NTCA and TAG websites.

 

Submitted by Erica Lessem, TAG
Donna Hope Wegener, NTCA
Kenyon Farrow, TAG

 

 

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