FDA Policies Contribute to Serious Domestic Drug Shortage
Our domestic pharmaceutical drug shortage situation is a direct result of FDA regulations, FDA reviewer turn-over/project overload and pharmaceutical companies outsourcing production outside the United States.
These three factors are a key part of the current shortage which has many ingredients such as the high cost of conducting business (shipping, labor, tax, and mfg/dist plant overhead). With all of the current pharma mergers and acquisitions, it’s a miracle only 246 products are in short supply.
Those pharma companies that left Puerto Rico and the mainland United States now have to deal with US Customs and the FDA Import Division along with your host nation’s requirements. The low foreign labor cost benefit analysis may not have accurately accounted for shipping supply delays and operating cost over-runs.
FDA, along with the center specific review divisions, have some turn-over and training issues to contend with, too. Maintaining domestic compliance with 21 CFR Drug Regulations through the systems approach with certified drug investigators is proving to be a difficult task for the FDA Districts and Center Departments. The perfect storm conditions have gathered for a serious drug shortage beyond the 246 we currently have on the books.
It is a national security issue when the US has drug shortages of vulnerable population drugs and critical care maintenance pharmaceuticals on the shortage list. The Quality by Design (QbD) system will further compound the domestic and International chemical & biotechnology drug product development cycle. The ability to react to a vulnerable population drug shortage should be the focus — not outdated chemistry manufacturing control (CMC) regulations.
The pharmaceutical industry and FDA must collaborate to mitigate further risk to national security. We all have a major stake in health care continuity and national security.
Sound scientific method without FDA manufacturing micro-management should be the focus. A drug supply contingency plan must be approved by FDA for drug production to react to a major market shortage. Let drug manufacturers put in a market shortage contingency plan for their drug products or let the market figure out the best way to conduct business.
FDA needs to focus on QA and not the business side of the pharma industry.
A final message to the pharmaceutical industry: come back home to the US. There are plenty of truly skilled individuals ready to work, and land prices plus pad sites have generally gone down. Come on down and build your plants in my state of Texas — we are a business friendly state with no state tax.