USP Becomes a Member of BARDA’s BioMaP-Consortium

The US Pharmacopeia (USP) announced on April 22, 2024 that it has joined the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), which consists of members of the biopharmaceutical supply chain to support the Biomedical Advanced Research and Development Authority (BARDA) in Health and Human Service’s Administration of Strategic Preparedness and Response (1). The BioMaP-Consortium plays a role in responding to public health emergencies by getting industry partners to expand capacity and capabilities. BioMaP-Consortium currently has 135 members, including eight non-profits and three institutions of higher education (2).

Drug shortages can have a serious negative impact on the public health. FDA requires manufacturers to provide the agency with information on possible quality problems that may cause delays in production (3,4). “Although the regulators have revved up efforts in recent years to better prevent and address drug shortages, serious problems continue to plague drug production and distribution, particularly for a number of generic injectables” (4).

USP will work with BioMaP-Consortium to advance preparedness through the development of medical countermeasures. Consortium partners work to increase visibility into vulnerabilities in the drug supply chain. This will help prioritize medicines that might benefit from increased supply chain resilience. USP will also help accelerate innovations through analytical method development and process controls, especially for advanced manufacturing technologies.

“We are thrilled to join the BioMaP-Consortium,” said Ronald T. Piervincenzi, PhD, CEO of USP. “For more than 200 years, USP has worked to assure the quality of medicines and medical products. We’re proud to leverage our expertise to support BARDA in expanding the manufacturing base for medical countermeasures, including therapeutics and vaccines, to tackle the challenges of today and the biosecurity threats of tomorrow.”

The problem of drug shortages isn’t specific to the United States. In the European Union, regulators also have established procedures and guidelines to combat drug shortages. The European Medicines Agency’s (EMA’s) Medicines Shortages Steering Group (MSSG) created a voluntary solidarity mechanism in 2023 that was based on a plan set up during the COVID-19 pandemic and which can only be used under limited conditions. It is a last resort to be used after EU Member States have exhausted other possibilities (5). EU Member States may ask other member states for stock if a critical shortage is faced. The mechanism is part of the MSSG Toolkit, which includes recommendations for monitoring drug supplies.

In December 2023, EMA also published a list of critical medicines as part of efforts to prevent drug shortages. The list includes drugs that have the potential to be limited in supply. “Medicines on the list can continue to be prescribed and used as usual by patients and healthcare professionals. Additional reporting requirements for marketing authorization holders and national competent authorities will be established and become effective once the proposed pharmaceutical legislation becomes applicable,” EMA stated in the press release (6).

References

1. USP. USP Joins BARDA’s BioMaP–Consortium. Press Release, April 22, 2024. https://www.usp.org/news/usp-joins-barda-biomap-consortium
2. Biomap-consortium. Current Members. Biomap-consortium.org (accessed April 22, 2024). https://www.biomap-consortium.org/
3. FDA. Drug Shortages. FDA.gov (accessed April 23, 2024).
4. Wechsler, J. Drug Shortages Continue to Plague FDA and Manufacturers. Pharm. Technol. 2023 47 (7).
5. EMA. EMA Takes Further Steps to Address Critical Shortages of Medicines in the EU. Press Release, Oct. 24, 2023. EMA.Europa.eu. https://www.biopharminternational.com/view/ema-creates-mechanism-for-support-during-drug-shortages
6. EMA. First Version of the Union List of Critical Medicines Agreed to Help Avoid Potential Shortages in the EU. Press Release, Dec. 12, 2023. https://www.biopharminternational.com/view/list-of-critical-medicines-published-in-eu