Expert Recall

By Willie Bryant

The FDA recently announced an international effort to identify and shut down internet websites that appear to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers.  The agencies’ Offices of Criminal Investigations and Enforcement, working with the Center for Drug Evaluation and Research, have targeted more than 130 websites and issued warning letters to more than 20 persons or companies responsible for them. The letters request a response to the FDA within fifteen days regarding corrections the companies have made to eliminate the violations.  The Agency also notified Internet service providers and domain name registrars that these web sites are selling products in violation of U.S. law.  None of the identified web sites are registered in the United States or Canada.

Since Internet web site sales became a source of medications for consumers, there have been continuing concerns and much discussion and publicity over the possibility that the drugs have not been subjected to appropriate manufacturing, packaging, and/or distribution controls. There is further concern that these drugs may not even be providing the indicated health benefits.  The FDA states that these Internet purchased drugs “are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers.”  Regulatory efforts such as warning letters to international persons and companies may or may not result in cessation of sales. What is most concerning, however, is that there usually is no recall effort and little, if any, recourse for consumers to return products or recover their money.

The FDA has not previously been able to monitor the world’s drug websites and although efforts are being made to combat their illegal sales, I doubt that FDA and/or other government’s agencies will eliminate such operations. Consumers should follow FDA guidance and protect themselves from unscrupulous web sites and defective, counterfeit, or otherwise misbranded medications.

The FDA is working hard to educate and protect consumers. In fact, the FDA has provided numerous text documents that provide guidance to consumers to safely purchase online medicines. Additionally, the FDA provides a significant warning on twelve (12) medications that should not be purchased over the internet or from foreign sources as they may have serious side effects.  What is most critical now is that lines of communication between manufacturers, online retailers, international regulatory agencies and consumers are open and allow for a two-way conversation. This way, if and when a product safety issue arises, all affected parties can be notified quickly and effectively.

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