On May 13, the U.S. Food and Drug Administration (FDA) led a foreign mail inspection in West Miami-Dade, Fla., designed to weed out thousands of counterfeit and unapproved medicines and stop them from entering the country.
The three-day search had agents poring over packages of illegal pharmaceutical drugs, dietary supplements and home remedies mailed from foreign countries. Reporting on the inspection, the Miami Herald noted that many medications are “purchased from foreign suppliers over the Internet, an increasingly risky shopping place for pharmaceutical drugs with unsafe ingredients, inaccurate dosages and false expiration dates.”
The inspection and subsequent media coverage highlights four key barriers to mitigating the threat of counterfeit drugs:
- Regulation of Internet pharmacies. Online pharmacies should be subject to the same rigorous oversight and standards that govern their offline counterparts. “In addition to requiring licensure through a national internet pharmacy licensing program such as Verified Internet Pharmacy Practice Sites (VIPPS), said PSM Vice President Bryan Liang, MD, PHD, JD, “We need new legislation that prohibits financial transactions for drug sales of unlicensed online pharmacies and creates substantive criminal penalties for any party, including websites and search engines, who engage in the illegal sale of contraband or counterfeit drugs.”
- Lack of regulation for products trans-shipped through foreign countries. While the West Miami-Dade inspection weeded out medicines shipped from Latin America and the Caribbean, even “safe” countries like the Canada and the United Kingdom pose threats due to lax regulations on medicines earmarked for other countries. For example, fake or low-quality drugs made in countries around the globe could ship through Canada to the U.S. without Health Canada’s oversight.
- Additional FDA agents for Internet investigations, including foreign assignments to source countries. Criminals selling counterfeit or unapproved drugs over the Internet are beyond the reach of FDA regulators and investigators. As we told the Office of Intellectual Property Enforcement Coordinator (IPEC) earlier this year, by exploiting the anonymity of the Web and the complex jurisdictions of international criminal laws, purveyors of these unsafe medicines remain outside the reach of domestic law enforcement.
- Additional onshore support and authority. The U.S. has 300 customs ports, but the FDA has only 200 port inspectors and a mere 17 inspectors to cover all international mail centers. We must hire more inspectors and grant the FDA and other agencies the authority to destroy unapproved drugs entering the U.S. rather than returning them to the criminals who sent them here—a sentiment echoed by one FDA supervisor who told the Miami Herald that the vast majority of intercepted pharmaceuticals were returned to sender: “We have no authority to destroy them. We have to send them back.”
According to the Miami Herald, the Miami Customs facility processed about 36 million pieces of foreign mail last year. Of that total, inspectors relayed between 8,000 and 10,000 foreign pieces containing unapproved medicines to the FDA for further assessment—showing that the threat of counterfeit drugs may be hitting closer to home than many are aware of.