Improving the Integrity of the Drug Supply in a Global Marketplace

By: Margaret A. Hamburg, M.D.  

Last week FDA announced that a counterfeit version of a cancer drug had surfaced in the United States. It was labeled as Altuzan, a product approved in Turkey and not approved in the United States.   The counterfeit did not contain the active ingredient of Altuzan.  Unapproved foreign drugs, including the counterfeit, were purchased by medical practices in the U.S. from a foreign supplier.

This discovery comes only a few months after FDA informed 19 medical practices in three states that they had purchased unapproved foreign drugs, which may include the counterfeit version of Roche’s Avastin.  Roche is the company that manufactures Avastin approved for marketing outside of the United States. This counterfeit was also purchased from foreign suppliers and was also nothing but a sham since it did not contain the active ingredient of Avastin.  

Margaret Hamburg, M.D.For patients with cancer, combating the disease is difficult enough. But to learn that the cancer drug you were taking to save or prolong your life might be nothing but a counterfeit is unthinkable.

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). Genentech’s Avastin products are safe and effective for their intended uses, therefore cancer patients that have been receiving these products should not be concerned.

FDA does not know whether patients actually received counterfeit Altuzan or Avastin.  Nevertheless, these cases illustrate that in today’s global economy much more needs to be done to ensure the integrity of the drug supply.

Combating snake oil salesmen was one of the FDA’s earliest jobs more than 100 years ago. But fighting the snake oil salesmen of today is getting harder. Today, FDA-regulated products originate from approximately 300,000 foreign facilities spread across more than 150 countries.

Last year, we counted nearly 24 million shipments of FDA-regulated products that arrived at U.S. ports of entry. Just a decade ago, that number was only 6 million.  Approximately 80% of the manufacturing sites for the active pharmaceutical ingredients used in FDA-approved drugs are outside of the United States and 40 percent of finished drugs consumed in the United States are manufactured overseas.

Consumers should have a high degree of confidence that drugs distributed through legitimate channels are safe, effective and of high quality.

The complex nature of supply chains makes the task of ensuring the safety and quality of the medicines remarkably challenging.  Moreover, as the Internet introduces more players into distribution channels, there are more opportunities for criminals to make money by producing or selling counterfeit and other substandard products.

In the past, we’ve relied on measures taken at our borders to ensure the safety of FDA-regulated products. Under this new reality of globalized production, that is no longer enough.  The ever-increasing percentage of imports and the blurring lines between domestic and foreign products must be a factor for us all.

FDA is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by manufacturers and other stakeholder, and enhancing collaboration with international regulatory counterparts.

FDA’s investigations into drug counterfeiting activities and relationships we’ve built with our foreign counterparts helped to uncover the latest counterfeits.  Health care professionals must also play a role in protecting patients from the risks of counterfeit, contaminated, improperly stored and transported, ineffective, and dangerous products by being more vigilant about their drug purchases. FDA has provided useful advice on how to identify whether their distributor is U.S. licensed or the products they received are FDA-approved.

But we also need to modernize the Federal Food, Drug, and Cosmetic Act, which was enacted in 1938, long before there was a truly global marketplace. These crimes warrant more severe consequences; we need enhanced criminal and civil penalties.  Under current law, there’s a steeper penalty for counterfeiting a designer purse than a drug product.  We also need requirements that manufacturers and other supply chain participants notify FDA when they become aware of incidents that could create a drug safety issue or disrupt supply. In addition, we need stronger rules requiring importers to provide information at the border demonstrating their compliance with FDA product standards.

We also need authority to require a robust system to track and trace all drugs throughout the supply chain. It would provide greater transparency and accountability in our nation’s drug supply, help to prevent the introduction and improve identification of counterfeit and other substandard drugs, and facilitate recall efforts.

In our increasingly complex and globalized world, these additional authorities would help ensure that the FDA can continue to protect the public health of our citizens from risks of exposure to unsafe, ineffective, and poor quality drugs.

Margaret Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

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