New information has come to light that poses a threat for continued consumer access to intravenous vitamin C (IVC), a potent, safe, and natural treatment for viral and bacterial infections and some cancers. It is a blatant example of our crony medical system. If we don’t stand up and send a strong message to Congress and the FDA, affordable IVC will be a thing of the past.
In 2017, McGuff Pharmaceuticals received FDA approval for an IVC product for the treatment of scurvy, and thus market exclusivity. The FDA notified other manufacturers of IVC that they must stop producing it, giving them a one-year grace period that has now expired. McGuff has subsequently raised the price of IVC.
Some historical context is necessary to understand why and how this happened. The FDA first targeted IVC after the launch of its Unapproved Drug Initiative in 2006. This document laid out policies of enforcement discretion for drugs that were being marketed without FDA approval. IVC had been approved for safety under the original Food, Drug, and Cosmetic Act in 1938. In 1962, Congress passed a law requiring drugs to prove efficacy in addition to safety. Drugs that were approved for safety between 1938 and 1962 could remain on the market for the time being, but a separate process began to assess the efficacy of these products. Drugs that were found to be effective would still require FDA approval (IVC fits into this category); drugs that were found ineffective would be pulled from the market. It is likely that IVC was not seen as a priority in 1962 but came onto the FDA’s radar in 2006.
From the FDA’s Summary Review of McGuff’s product, we know that FDA was in communication with McGuff in 2007 regarding the status of IVC and the need for FDA approval. In the years that followed, McGuff was in regular communication with the FDA regarding the approval of an IVC product.
In 2010, McGuff received a warning letter from the FDA that, among other things, ordered the firm to stop marketing IVC because the FDA determined it was an unapproved drug. At this time, ANH-USA sprang into action to get the FDA to back off IVC.
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