FDA Works to Balance Domestic Drug Supply and Market Freedom

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Patrick Stone, President, TradeStone QA

The balance between cost effectiveness and a safe drug supply may be measured in the amount of poor/under-employed patients not receiving their medication. These individuals may seek their pharmaceuticals online from imported sources thus breaking the law and possibly receiving harmful counterfeit drug products. Counterfeit drugs and placebos, labeled as heart medications, blood pressure medications, diabetes medications, etc., are currently hospitalizing a vulnerable proportion of American citizens.

The FDA does not publicly go after counterfeit drug operations and the Office of Criminal Investigations (OCI) at FDA would be responsible for the interdiction of such criminal activity. There are very few OCI agents in the FDA, so counterfeit drug searches are not conducted Sheriff or Texas Ranger style. If the FDA OCI get a tip about a counterfeit operation they usually go in with Sheriff and FBI/DEA/HS for back up.

FDA public affairs and media relations may not go far enough explaining and describing the extreme dangers of buying health care maintenance drugs from an unapproved imported source.

There are many reputable foreign pharmaceutical companies legally and safely distributing effective imported medications. The FDA is currently focused on tobacco and food products like rural milk production; counterfeit pharmaceuticals appear to be low priority. Many of the counterfeit drug operations take place outside the United States and are imported in through legal or illegal channels.

The FDA Import Division would be the most responsible resource for stopping the flow of harmful drug products. The DEA and DOJ are focused on scheduled narcotics and bulk illegal substances. When the product comes in a pill bottle sold in most drug stores the priority may also be very low.

Health-care customers and marketing business firms need to understand the US regulations for importing health-care products from licensed broker that goes through the FDA/US Customs regulatory oversight. It is always good to verify that the product you purchased matches the description on the package insert.

The US government is trying to balance security and freedom of choice on the razors edge. It may take some time to ensure security at the cost of your advertising freedom. It is always a good idea to ask your doctor or pharmacist about your drug products and how to physically identify your medications.

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

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