Counterfeit Drugs Enter the Pharmaceutical Supply Chain

According to the article “Secure The Pharmaceutical Supply Chain From Risky Counterfeiters,” leading members of the House and Senate have proposed a legislative draft to establish a national ‘track and trace’ program for prescription drugs. The Food and Drug Administration has been dealing with an increasing number of cases involving counterfeit prescription drugs. In 2010, the FDA’s Office of Criminal Investigation opened 72 cases involving fake drugs. This is highly problematic for the pharmaceutical supply and very risky for the health of individuals. Some of these cases have involved counterfeit Adderall, Vicodin, Xanax, flu medicine, and cancer drugs. One reason counterfeit drugs are able to enter the nation’s pharmaceutical supply chain is the contradicting state regulations that are in place. Each state has varying compliance rules. There is not a federal level system in place, and the FDA does not have the authority to implement federal standards that can ensure the authenticity of prescription drugs from the manufacturer into the hands of prescription drug users.

In order to combat the introduction of counterfeit prescription drugs into the nation’s pharmaceutical supply chain, there needs to be compliance standards at the federal level put into place. The ‘track and trace’ program proposed by members of the House and Senate calls to rid of the contradictory state regulations and increase the security of the pharmaceutical supply chain by setting up countrywide standards. Many industry participants, such as manufacturers, chain drug stores, wholesalers, and distributors, have expressed their support for this proposal.

A downside to this national ‘track and trace’ system is that it will be more costly for pharmaceutical companies. The high compliance costs that the pharmaceutical companies may incur could cause these companies to decrease operations, limit distribution, or even shut their doors entirely. More supply disruptions and drug shortages could occur as a result of the higher compliance costs. However, complying with the regulations of each of the individual states can also run costly for this industry as well.

Although the proposal for a unified national system of security for prescription drugs that Congress is putting forward may be costly, it would ensure that patients are receiving legitimate prescription drugs instead of counterfeit ones. This ‘track and trace’ system, when implemented at a national level instead of state-by-state, may be more cost effective in the long run.

A uniform system for the national pharmaceutical supply chain would decrease the ability for counterfeit prescription drugs to enter and be distributed to patients. Even though it could impose higher compliance costs for this industry, the benefits of ensuring safety for prescription drug users cannot be ignored.

Do the costs of implementing a uniform system for the pharmaceutical supply chain outweigh the benefits? Or do the benefits of a uniform system outweigh the costs?




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8 thoughts on “Counterfeit Drugs Enter the Pharmaceutical Supply Chain

  1. This is pretty interesting, and I’m left wondering how it is that counterfeit drugs make it into the hands of suppliers in the first place? This sounds like another classic case of Federal Government vs. States Rights. I think that compliance costs would, if anything, ultimately raise costs at the end of the chain; really who I think this would effect the most is health insurance companies, who would be left to foot the bill. But in no way would increased regulation slow down this behemoth of an industry. I think the benefits definitely outweigh the costs if human lives are at stake, but that’s a moral view, not a business one…

  2. I find it interesting how companies have trouble even tracing that the drugs are counterfeit. We need to have our people of the world safe from harmful pharmaceutical drugs. If it means we need strong government regulation, so be it. We need to focus on the key issue here and that is the safety of the people.

  3. I believe that the benefits of a uniform system greatly outweigh the costs. The benefits of the uniform system could help to save lives. Pharmaceutical companies should want to help save lives because a dead person cannot buy prescription drugs from them. As stated in the post, many industry participants already support the uniform system proposal. I could see how low-level drug stores would be opposed to the proposal due to the costs, however, we must look at the greater good of the ability of this uniform system to help save lives from counterfeit drugs. It is in the best interest of all industry participants to support this proposal, both on moral grounds and on long-term strategic business grounds.

  4. I agree with the previous comments that the benefits of implementing the ‘track and trace’ system would definitely outweigh the costs. I am dumbfounded as to how so many counterfeit drugs are making their way into pharmacies and ultimately into the hands of consumers. Where’s the quality control? Shouldn’t a pharmacist realize that what he/she is giving to patients is not a legitimate prescription drug? Of those 72 reported cases, how many resulted in deaths? This problem needs to be solved immediately. The only downside is that the end-user would pay for most of the increased costs. Some of it would be covered by insurance, but they would not bear the entire cost increase. And prescription drugs are expensive enough as is.

  5. I agree with others. Safety is the main concern when it comes to giving out prescription drugs. It is alarming that fake or counterfeit drugs could leak into pharmacies. It also gets you wondering what else is getting by with out people noticing. It would be a big downside in the increase in drugs since they are expensive as it is. But when it comes to safety of individuals it is more important.

  6. It is very important to have the right drugs becaus e if they are counterfit then this can kill you. The company needs to check each and every box and make sure it is correct. if bad medicine goes to their supply chain then this will make the company as a whole look bad. Even if it is a good company. It is essential to implement the uniform system or else this can make the company look bad and it will lose sals in the long run.

  7. The misconception here is that these drugs are created in the United States by pharmaceutical manufacturers. These “counterfeit drugs” are often made overseas and sold to online pharmacies such as, The only drugs usually available on these websites are the VERY popular ones, V iagra, C ialis, Pro pecia, La six, etc. Some of these pharmacies are legit, and get their supply from Canada, which has many more generics than the United States does on some of the most popular medication. The majority though, are selling counterfeit drugs, in the same shape as the real thing with little to none of the active ingredient. It is a scary thing, and people need to be aware where they are buying from!

    1. Note: I had to space out the drug names because the filter wouldn’t allow the post to go through with V iagra and C ialis in the post. But it is part of my point.

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