The IOM report on increasing safety of imported drugs, devices, and food

April 18, 2012 By Steven Greer, MD

The biggest problem facing the FDA is the growing awareness that the agency cannot remotely guarantee the safety of the prescription drugs, medical devices, and foods imported for American consumption. With the highly publicized deaths of Americans caused by counterfeit heparin traced back to China, and then news of counterfeit cancer drug Avastin, congress and The White House are taking notice. To give appearances that the agency is “doing something”, the FDA commissioned the Institute of Medicine (IOM) to “study the problem” and draft a lengthy report. We interviewed the Chairman of the IOM team, Jim Riviere, a doctor of veterinary medicine and expert at pharmacokinetics.

The report lays out the scope of the problem. It states that more than 80% of the active ingredients in medications come from outside the U.S., and that there are approximately 300,000 plants outside the U.S. which the FDA should inspect. However, those numbers do not match what the FDA gave to us. In our previous article, the FDA exclusively told us that there are only 7,321 non-U.S. medical device manufacturing plants that they track/inspect only 2,178 non-U.S. drug manufacturing plants.

Nevertheless, the FDA cannot inspect more than a small fraction of the foreign medical plants, much less inspect the more numerous and less regulated foreign food plants. Moreover, issues of trade agreements and foreign policy politics makes the FDA the least capable government agency to deal with the problem. The White House, State Department, DOJ, and congress are the entities with the necessary authority.

The IOM report makes some recommendations on addressing the current inability of the FDA to assure the safety of what we consume. The recommendations seem naive of geopolitical realities, and emphasize a need for The U.S. to rely more on the “mature regulatory” agencies of other countries that are counterparts to the FDA in order to avoid duplication of efforts. The fact that the largest manufacturers of active ingredients in drugs are imported from countries not classified as “mature regulatory” countries (e.g. China, India, Southeast Asia, etc) is addressed by a recommendation that the U.S. “help build infrastructure” in those countries. The report also recommends relying more on private industry for the inspection process, much like the fox watching the hen house.

The more realistic and feasible actions that congress and the FDA can take to assure the reliability of the manufacturing chain to prevent counterfeit products, and to detect unsafe medical devices and drugs, are glossed over in the report. For example, a unique numeric device identifier (UDI), like a serial code, is not currently mandated to be on medical devices. The benefits of a UDI, according the a report in 2006 from the FDA, are, “Medical device UDI has the potential to yield several benefits, including reducing medical errors, facilitating recalls, identifying incompatibility with devices or potential allergic reactions, improving inventory control, improving reimbursement, and reducing product counterfeiting.” The medical device lobbyists have opposed UDI’s, and despite congress requiring UDI’s five years ago, the FDA is yet to implement them.

Another example of a tangible solution the FDA should be doing to increase safety is the Sentinel surveillance system to better detect when unsafe drugs or devices are harming patients. This too was mandated in the 2007 FDAAA. The current MAUDE database is woefully inadequate, and the vast majority of safety complaints made by doctors and patients never reach the FDA.

The long delays with enacting the Sentinel surveillance system and the UDI are embarrassments for the FDA. The FDA commissioned the IOM report, and the Chairman did not want to speak about them on camera.

Finally, a more radical solution to the impossibility of the FDA ever inspecting the manufacturing plants around the world is to simply mandate that pharmaceutical and medical device companies manufacture the products in the U.S., with certain exceptions. This was how it was done until the last decade when the drug industry consolidated, cut costs, and escaped the watchful eye of the FDA in places like Singapore, Ireland, India, Russia, and South America. Millions of American jobs would be created as well as increasing safety of the supply chain.