A May 16th Food and Drug Administration news release reported that U.S. Marshals had seized more than $11,185,000 worth of unapproved drugs. They did this at the request of the FDA because the medications are unapproved and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The FDA complaint for forfeiture in paragraph 3 states, “articles of drug, as described in the caption, which articles were shipped in interstate commerce from outside the state of Ohio.”

The “interstate commerce” refers to the Commerce Clause in Article I, section 8, clause 3 of the U.S. Constitution.  It reads, “The Congress shall have the power … To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes;”

To its credit, the FDA did not try to expand the meaning of the Commerce Clause by seizing the drugs in the State of New Jersey where the drugs were manufactured.  The FDA waited until the unapproved drugs had participated in interstate trade and then seized them.  This is the Constitutional way for the federal government to enforce the commerce clause.

The FDA changed its drug enforcement policy in 2011 when it published Marketed Unapproved Drugs Compliance Policy Guide.   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 action by the FDA will greatly increase the time and cost of getting drugs to the market.  It will deprive patients of having more choices and less expensive drugs.

Because the FDA is following the original intent of the Commerce Clause, there is a way to partially circumvent this FDA policy.  The drug manufacturer could make and sell the medication in New Jersey because this is not part of interstate commerce.  The company might also manufacture and sell the drugs in other states without crossing state lines.

Of course this is inefficient and will probably increase the cost of the medications.  However, it is a way to get medications to the people in spite of the efforts of the federal government to over regulate the markets.

Bert Loftman

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