Can Excess U.S. Production Capacity be a Key to Essential Medicines Production?

An AAM blog posted this morning (here), titled The Quickest Route to U.S. Essential Medicines Production: Existing and Idle Production Sites, seems to think that the answer to this post’s titular question is Yes, and it at least provides another option for consideration.  The AAM post cites a report (here) by Professor Anthony Sardella from Washington University that indicates “49% of the generic pharmaceutical manufacturing capacity in the United States is currently idle.  Of the 37 manufacturing sites surveyed, only two were at full capacity, while 30% were at or less than 50% capacity.”  In addition, the report indicates that many of the firms with excess capacity could be at full capacity within a year.

While this option would be faster and cheaper than building new facilities from the ground up, the question of the regulatory implications of this option and the ability to fit the right products into the mix of existing firms’ manufacturing plans and capabilities may stand in the way (i.e., certain antibiotics must have totally separate manufacturing spaces).

Regulatory relief could drive firms towards looking at this option but, again, if they operate as CMOs for companies that have current regulatory approvals (ANDA/NDA/BLA), there are still the issues of how excess capacity can be used, need for increases in personnel and their training, and the length of time for transfers of technology to be accomplished, along with any FDA regulatory inspections and approvals for such products.  There may also be intellectual property issues or confidential commercial considerations that would need to be accommodated.

I’m not saying this wouldn’t be a good idea, because I think it is, but the timelines, regulatory approvals, and commercial considerations may be a bit of a roadblock.  Still, it’s something to evaluate until more permanent solutions are achieved.  The key is getting redundancy into the system of drug production to limit shortages of essential medicines.  How well companies would share information and technological know-how would also dictate the success of such endeavors.