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The FDA needs a mission change

The FDA needs a mission change
The FDA needs a mission change
By Bert Loftman

Yesterday, a Food and Drug Administration (FDA) news release said that U.S. Marshals had “seized more than $11,185,000 worth of unapproved drugs.” The news release said the complaint was against Ascend Laboratories of Montvale, N.J. and Masters Pharmaceuticals, Inc. of Cincinnati, Ohio. A spokesperson at Masters Pharmaceutical relates that their company was not named in the FDA complaint and that Masters simply acts as the third-party logistics provider for Ascend.

Among the medications were “Pramoxine-HC Otic Drops dated August, 2011. It is intended to treat infections of the external ear caused by microbes and to control itching. Another drug was Urea Cream 40%, dated January, 2012. It is intended to treat skin-thickening conditions such as dermatitis and eczema.

The FDA news release went on, “The seizure of these products is consistent with the enforcement policy set forth in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide, which established that unapproved new drug products first marketed after Sept. 19, 2011 are subject to immediate enforcement action at any time without prior notice.” This changed the prior guidelines of 2006. At no point does the 2011 revised guidelines say that Congress approved the new regulations.

The FDA 2011 Compliance Policy Guide points out that the FDA was established in 1938 to ensure drug safety. In 1962, Congress added efficacy to the guidelines. The administrative implementation process was called the Drug Efficacy Study Implementation (DESI). It is the need to prove the medication effective that has greatly increased the time and cost to get drugs to the market. A counter argument is that this is unnecessary because doctors go through years of training and regularly attend meetings about how to treat diseases.

The FDA complaint against Ascend Laboratories says on page 6, “which articles were shipped in interstate commerce from outside the state of Ohio.” This complies with the Commerce Clause, Article I, Section 8, paragraph 3 of the U.S. Constitution, “To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.” It also implies that Ascend pharmaceuticals could market and sell their medications in New Jersey as well as manufacture and sell them in the other states.

The FDA has made it known that it plans to remove unapproved drugs from the market. The seizure of Ascends Pharmaceutical’s drugs is part of this process. On page 3 of The Policy Guide, the FDA estimates that there are “several thousand drug products are marketed illegally without required FDA approval.” The footnote says, “This rough estimate comprises several hundred drugs (different active ingredients) in various strengths, combinations, and dosage forms from multiple distributors and repackagers.”

This is a big endeavor. A major question is, does this serve the public interest? It prevents citizens from buying their medication of choice. It may mean a significant loss of jobs for Ascend Laboratories. This company primarily manufactures generic and over the counter medications. It is highly doubtful that it will try entering the FDA approval process.

Perhaps rather than the federal government removing useful medications from the market, it is time to reexamine the mission of the FDA. An alternative way of doing the Research and Development of medications is to have individual states do the R&D within their state. Only some states would likely participate and those states would likely have state regulations. Once the medication was found to be safe and effective it could be marketed in that state. The pharmaceutical company could then apply to the FDA to have the medication sold across state lines.