FDA to Open Regulatory Offices in Foreign Countries
On Oct. 16, Department of Health and Human Services (HHS) Secretary Michael Leavitt announced that the U.S. Food and Drug Administration (FDA) will send personnel overseas to staff offices to help ensure the safety of imported food and drugs. The plan calls for staff to be assigned to offices in China, India, Europe, and Latin America. Many assignments will begin before the end of 2008.
In a press release, FDA Commissioner Andrew C. von Eschenbach said, "The globalization of the food supply and medical product manufacturing has demanded that we do things differently. Through our Beyond our Borders initiative, we won't have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight — we'll have staff living there and working on the ground 365 days a year."
The change comes as a result of problems with mostly uninspected products increasingly coming from firms that have shifted their manufacturing and production overseas. For example, in 2007, the problems included melamine contamination of pet foods that sickened and killed pets, toothpaste contaminated with antifreeze ingredients, and an FDA ban on five different types of seafood that had been contaminated with microbial agents not approved for use in the U.S. More recently, melamine has been discovered in Chinese milk-based products such as infant formula and various candies sold both here and abroad.
There have also been concerns about drugs and medical devices commonly used in the U.S. For instance, FDA said many allergic reactions and even some deaths were attributed to ingredients in Heparin, a popular blood thinning drug. The agency also barred from import more than 30 generic drugs made in India because of poor quality control at the factories, according to an Oct. 16 Washington Post story about the HHS announcement.
HHS announced that it will open an office in Beijing before the end of 2008, and two other offices will open in other Chinese cities in 2009. A total of eight U.S. officials will operate in China. Ten employees will be posted in India once arrangements are negotiated with Indian officials. Other offices will open in nine Latin American countries, in Europe, and in the Middle East. According to an Oct. 17 BNA article (subscription), there will be about 43 employees total assigned to the foreign offices. The article notes it will cost $30 million to establish the offices by the end of 2009 and an estimated $20 million annually to maintain the offices.
The FDA staff will work with government officials and the companies producing the goods in an effort to improve quality assurance. They will inspect facilities, provide technical assistance, and help create third-party certification programs, according to the announcement. The certification programs require HHS to accredit independent organizations that would inspect manufacturing and production facilities and declare that the products meet U.S. import standards. Once their facilities are certified, the firms' products would gain expedited entry at American ports. Companies that do not meet certification would continue to work with FDA staff and government officials to improve the safety of their products.
The HHS plan grew out of an interagency working group, chaired by Leavitt, established by President Bush in 2007 to address the increasing number of safety scares consumers faced. The report issued by the working group in November 2007 largely calls for a series of incentive programs to get businesses to voluntarily comply with standards that may be established either by industry groups or the regulating agencies and then used by third-party inspectors. Incentive programs can be effective if based on the threat of direct regulatory action, but they are less effective when used with voluntary standards. (See OMB Watch's analysis of the working group report here)
According to the Post article, Leavitt and von Eschenbach admitted that new staff would not be able to meet the growing need for inspections of facilities in growing economies around the world. The two "hoped manufacturers would voluntarily pay for inspections by independent parties — including foreign governments and companies — to verify their plants meet U.S. standards," according to the article. Expedited access to American consumers would provide the incentive for firms to seek out independent inspections. The FDA does not, however, have the authority to accredit these independent inspection organizations. It would have to seek such authority from Congress.
A variety of legislative alternatives have been proposed and/or passed to address FDA's inspection capabilities, as well as other problems the agency has in meeting its food and drug safety responsibilities. For example, on Sept. 20, 2007, Rep. John Dingell (D-MI), chair of the House Energy and Commerce Committee, introduced H.R. 3610, which calls for mandatory user fees on food and drugs imported into the U.S. FDA would use the money for increased inspections and testing of imports. It also contains enhanced civil penalties for violations and other provisions expanding FDA's responsibilities. In the meantime, Congress reauthorized the Prescription Drug User Fee Act (PDUFA), which increased user fees on drug companies to pay for safety and approval programs. User fees on food imports have not yet been authorized.