oncerned about the quality of the pharmaceutical supply chain, several congressional lawmakers want the US Government Accountability Office to review Food and Drug Administration oversight of foreign manufacturing plants.
In a letter last Friday, members of the House Energy and Commerce Committee asked the GAO to assess the progress the FDA has made inspecting foreign facilities since the agency undertook a new “risk-based” approach in 2010. They noted the United States imports more than $52 billion in medicines each year, but that “many of these products come from countries with less sophisticated regulatory systems.”
The lawmakers went on to note that there’s a “history” of counterfeiting, adulteration, substandard manufacturing, and data falsification over the past 20 years in China and India, specifically. As a result, they suggest there may be “inadequate oversight” and an “unequal playing field” compared with US drug makers that are subject to “more frequent and rigorous inspections.”
The letter was sent by House Energy and Commerce Chairman Fred Upton, a Michigan Republican, and Frank Pallone from New Jersey and the top Democrat on the committee. They noted the GAO issued a report in 2010 that the FDA had made progress in overseeing foreign plants, but that more work was needed.
Their request comes amid ongoing concern over the quality of finished medicines and active ingredients, thanks to a rash of quality-control scandals over the past several years. In 2008, for instance, 246 deaths in the United States were linked to a fake ingredient from China that was found in the blood thinner heparin. China is now the world’s largest supplier of active pharmaceutical ingredients.
In India, numerous drug makers have been cited for manufacturing lapses. The most notorious instance involved Ranbaxy Laboratories. Now part of Sun Pharmaceutical, the company became a poster child for quality control gaffes, and, two years ago, paid a $500 million fine as part of a settlement that included pleading guilty to two charges of violating drug safety laws, such as manipulating data.
To crack down, the FDA has moved to hire additional inspectors in both countries, although plans for China are moving slowly. The agency opened an office there after the heparin debacle, but it has encountered difficulties due to delays obtaining needed visas. Currently, there are two drug inspectors in China, and three more have been hired to oversee approximately 700 plans. An FDA spokesman said still more inspectors are expected to be deployed next year.
Meanwhile, troubling infractions continue. The agency has barred 38 plants in China from exporting all or some products to the United States. The lawmakers cited one episode in which FDA inspectors visited a Chinese company that supplies key ingredients to big US drug makers. When they walked into a quality control lab, a worker took a memory stick from a computer and ran when asked to see what he had taken.
Problems continue to emerge in India, as well. A recent FDA warning letter issued to Unimark Remedies noted that agency inspectors in March 2014 found evidence of “pests.” More specifically, there was a bird’s nest near the ceiling of a manufacturing building and bird poop in a warehouse. And a lizard was found in another warehouse. Still more troubling were several instances of problems involving data integrity in computer systems.
The FDA has begun working with the Indian government to bolster domestic oversight. An FDA spokesman told us that three inspectors work in the country, but others regularly travel there as well, so the total number varies. India’s drug makers have bristled at the attention paid by the FDA to ongoing shortcomings, which have prompted the agency to issue a steady stream of import alerts that ban products from being shipped to the United States.
The FDA spokesman said the agency will respond directly to the GAO but would not comment otherwise. A GAO spokesman said that the request “will go through our standard review process before any determinations are made. This generally takes a few weeks.”