FDA published FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain.
Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages.
This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.
Food and Drug Administration Safety and Innovation Act.
The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency’s ability to safeguard and advance public health by:
- Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products;
- Promoting innovation to speed patient access to safe and effective products;
- Increasing stakeholder involvement in FDA processes; and
Enhancing the safety of the drug supply chain.
To help the public keep track of the agency’s progress on these and other provisions, we’ve established a 3-year implementation plan, which is planned to be updated on a monthly basis.
Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s efforts have contributed to fewer new drug shortages and reduced the time to resolve existing drug shortages. This is due, in part, to authorities the agency now has, including those added by the Food and Drug Administration Safety and Innovation Act.
But despite mitigating or preventing hundreds of new drug shortages, disruptions in the U.S. drug supply continue to occur;
- due to drug quality problems
- vulnerabilities in the global supply chain
- unanticipated increases in demand
- market withdrawals of drugs or natural disasters
Executed by the Federal Task Force
- 2019, in an effort to address the national drug shortage problem, the federal Drug Shortages Task Force released a report that called for the adoption of risk management plans to proactively assess risk and to predict and prevent supply disruptions that could potentially lead to a drug shortage.
- 2020, Congress passed the CARES Act to require certain manufacturers to develop, maintain, and implement, as appropriate, risk management plans that identify and evaluate risks to a drug’s supply.
To further assist manufacturers with these requirements, it has issued draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to assist in the development, maintenance, and implementation of risk management plans.
Learn: Risk Management Plans to Mitigate the Potential for Drug Shortages
Brochure : GRP USA Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
For More Information: The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
CDER Small Business & Industry Assistance (SBIA)
View 2021 Recordings on YouTube
Report was updated on 2/21/20 to include revised economic analysis about production increases and supply restoration after a shortage. See the FDA Archive for the original Report.
Creating Risk Management Plans for Drugs.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.