By Phil Crooker, VP - Technical
There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on pharmaceutical supply chains when additional capacity needs to come on-line with existing facilities, restarting manufacture, technology transfer to new or alternate facilities and using new or alternate suppliers for components. Now more than ever our patients are dependent on medicines sourced through these complex global supply chains that are facing rapid changes and daunting challenges.
That momentum has now reached the point where the supply chains for these drugs could face the prospect of meeting potentially enormous new demand. On March 23, New York state in the United States received shipments of azithromycin, chloroquine and hydroxychloroquine from the U.S. federal government to use in a protocol agreed with FDA for expanded access to treat COVID-19 patients. Dosing will begin on March 24.
If the data are acceptable to FDA, there will be widespread demand for the drugs both in the United States as well as global markets where FDA’s decisions could be influential. The World Health Organization has also started large-scale clinical trials using these drugs. There are at least three possible steps in anticipation for commercial use that can be taken if these trials demonstrate acceptable efficacy to health authorities -
- Repackaging bulk product under CGMP into unit of use or other individual containers.
- Developing a commercially available convenience package for drugs used in combination.
- Creating a combination dosage form.
All these supply chain contingencies involve interactions with regulators about ensuring CGMP compliance and submitting right first-time regulatory applications in rapidly changing regulatory environment. Our regulatory consulting group includes 80+ former regulators who have experienced these situations on the agency side and who also have private sector experience in supply chain operations. They can help manufacturers rapidly navigate the process of re-tooling supply chains, ensuring compliance with applicable CGMP, submitting regulatory applications and being prepared to respond to agencies to drive solutions that work to protect public health.
Please contact Phil Crooker, Vice President – Technical, at Phil.Crooker@parexel.com or 1.864.593.8533 (mobile text and voice) if we can be of any assistance to your organization during this critical period.