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The coronavirus pandemic has escalated concerns in Washington D.C. over the U.S. dependence on other countries such as, India and China for necessary products including essential medicines, medical supplies such as masks, gloves, and medical equipment such as ventilators.
On Thursday, August 6, 2020, President Trump signed an executive order (EO) to increase U.S. manufacturing of medicines and medical equipment, lowering drug prices to prevent future shortages especially during another pandemic or other emergency.
The order includes a “Buy America” provision for federal purchases of medical supplies and equipment. The government purchasing market that are auxiliaries to the Department of Defense would all buy U.S. made products to meet certain essential needs. The order includes initiatives to accelerate the drug approval process and to support the development of advanced manufacturing techniques. This order is part of a four-month effort to reduce dependence on China for essential medicines and supplies.
The implementation of the EO is not finalized. A list of the essential medicines that will be covered under the order has been requested to be drafted immediately by the FDA. Within 180 days of this order, the Secretary of Defense and the Director of OMB, are required to identify weaknesses in the supply chain for Essential Medicines, Medical Countermeasures, and Critical Inputs deemed essential to meet the distinctive requirements of the United States Armed Forces. The Environmental Protection Agency (EPA) also has been asked to reduce certain environmental restrictions that may present obstacles to manufacturing new types of drug in the U.S.
The order has sparked responses from various stakeholders. The industry Association for Accessible Medicines that represents generic drug manufacturers wants greater details of the order and wants the government to ensure additional costs of producing drugs in the United States are considered in long-term government contracts with manufacturers. The Pharmaceutical Research and Manufacturers of America is concerned about the disruption of the global pharmaceutical supply chain.
What is the Implication of this order to the #medtech industry?
The benefits of the EO to the industry include:
- a directive to HHS to accelerate approval of FDA applications for drugs developed in the U.S.
- a directive for government agencies to enter profitable, long-term contracts with domestic manufacturers.
With potential increase in costs of production, we recommend that the reimbursement strategies are developed early on to ensure market uptake.
For more information, email us at info@girsinc.com or call us at 901-834-9119.
Sources:
https://time.com/5878064/essential-drugs-executive-order/
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).
About GIRS
For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.