FDA Policies Contribute to Serious Domestic Drug Shortage

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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 The ability to react to a vulnerable population drug shortage should be the focus — not outdated chemistry manufacturing control (CMC) regulations.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.

Patrick Stone is President of TradeStone QA and the author of Bubble Gum Badge – An FDA His-Story. You can follow him on Twitter.

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    The shortage has also spilled over to veterinary medications. Vets are having to euthanize dogs for heartworm (for shortage of Immiticide), mostly at shelters, etc. It shouldn’t have to be this way, and these problems go as far back as 2009 – apparently due to “production” problems.

    • Reply

      Yes, that’s true, the firm’s that now manufacture drugs are not fit for dogs or humans for that matter. As an advocate of FDA, the Agency has tolerated these approved imported drugs for a long time and have attempted, with many overseas inspections, to “fix” the problem. Most of these companies have no control over their operations from the GMP point of view. If these companies operated in the US, they would be under an injuction or out of business. The quality, purity and strength from these foreign drug manufactures lack any credibility. Oh by the way, their consultants are privateers, who are politically connected, and even have attempted to run for president. Of course their consultants have no knowledge or little about GMP requirements. Nor are these companies interested in manufacturing to US standards. They do know how to nod and BS there way out of any situation.

      I prefer not to be a name dropper. Incidentally, the price of drug have anything to to do with the drug manufacturers. Drug prices are fixed by the drug wholesale cartel that our government negotiates for the VA and health care.

      Anyway there are other approve treatments for heart worm such as Pyrantel Pamoate. You can spray the stuff on your bed sheets to prevent bed bugs.

      Please don’t shoot the messenger, I’m just trying to tell it like it is and the problem is not simple.
      Kind regards,
      Len

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