FDA May Outsource Overseas Drug Maker InspectionsJun 13, 2008 | Parker Waichman LLP
The Food & Drug Administration (FDA) is said to be considering a plan that would outsource the inspection of overseas drug makers to private entities. The FDA outsourcing proposal is drawing criticism, however, because a similar program for foreign medical device makers has been a failure.
The FDA has been under a lot of scrutiny lately, especially for its oversight of imported food and drugs. Since late last year, tainted heparin sourced from China has been blamed for at least 81 deaths and hundreds of adverse reactions in the U.S. It was eventually learned that the FDA had never inspected the Chinese plant where raw heparin ingredients were made.
Unfortunately, the heparin case is not an isolated incident. A recent report from the Government Accountability Office (GAO) found that, on average, foreign drug plants are inspected only once every 13 years. Critic have long argued that the FDA does not have the funding or manpower to police the massive amounts of food and drugs imported from overseas.
In May, the heparin debacle prompted FDA Commissioner Andrew von Eschenbach wrote a letter to Sen. Specter recommending an additional $275 million for funding food and drug safety. On Monday, the Bush Administration finally got around to asking Congress for those funds. Some of that money would be used to allow quicker entry for imports certified by private parties.
The FDA says it just does not have the manpower to inspect every foreign drugmaker that imports to the U.S. "It's very difficult to see how we could actually cover the entire globe," Janet Woodcock, head of the agency's Center for Drug Evaluation and Research, told Reuters. "If you consider many of these other plants aren't really inspected at all, putting in some type of program would be better than not covering them."
However, a similar program for foreign medical device makers has not been very efficient. Under the medical device program, it took the FDA two years to approve the first private inspectors that companies can hire to check their facilities. But the overseas medical device manufacturers have shown little enthusiasm for the program. Since then, only 12 third-party inspections have been conducted. Another 158 have jointly been conducted with the FDA.
One of the reasons that medical device makers have resisted private inspections is the cost. With relatively few FDA-approved private inspectors, they are able to charge exorbitant fees. It is simply more cost-effective for manufacturers to allow the FDA to inspect their plants - for free.
Many consumer advocates argue that the FDA is better suited to the inspections. They argue that private companies will have a financial incentive to keep drugmakers happy, and may downplay poor inspections.
That may have already happened with private food inspection companies. Yesterday, a Congressional committee subpoenaed nine private food inspection companies. The committee is investigating charges that private food labs may have been encouraged by importing companies to withhold tainted food samples in order to enable foods to reach U.S. consumers. The committee had already asked 50 multinational food companies for a variety of recall- and food-import records dating as far back as 2000.