Imported food and drugs in the U.S. have tripled in the past decade, making it tougher on regulators to police the safety of products that Americans consume, the Institute of Medicine said.
About 85 percent of the seafood Americans buy, 39 percent of fruit and nuts and 18 percent of vegetables come from abroad, according to a report today by the institute, a branch of the National Academy of Sciences that helps the government make health decisions. About 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs originate in nations outside the U.S.
The health of Americans are linked to regulators worldwide, a point made in 2007 and 2008 when dogs and cats were stricken by tainted pet food and people died from contamination in Baxter International Inc. (BAX:US)’s blood thinner heparin. The ingredients in both incidents came from China. The Food and Drug Administration needs to partner with regulators abroad to help bring them up to speed to protect Americans, the institute wrote.
“The integrated global economy demands cooperation across borders -- to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective,” Harvey Fineberg, president of the institute, based in Washington, wrote in the almost 300-page report.
The FDA asked the institute to examine gaps in the regulatory systems of developing countries and come up with a strategy for the agency to improve safety. The institute focused on countries that are predicted to be major pharmaceutical and agricultural trading partners with the U.S.: Mexico, Brazil, South Africa, India, Thailand and China.
“The FDA commissioned this study with the frank admission that its methods of ensuring product safety, inspections at factories and ports of entry, are inadequate when regulated products arrive at 300 different ports of entry from over 300,000 factories in 150 different countries,” according to the report, which was written by an institute committee of academics and regulators.
The FDA yesterday told health-care providers that it discovered counterfeit versions of Roche Holding AG (ROG)’s cancer medicine Avastin that contained no active ingredient. The fakes were in boxes marked Altuzan, Turkey’s version of Avastin, which isn’t approved in the U.S, the FDA said.
The FDA had made alerts about counterfeit Avastin in February that also didn’t contain the medicine’s active ingredient. The drug is approved in the U.S. to treat colon and kidney cancers that have spread, a type of brain tumor and a certain type of lung cancer.
Avastin is Basel, Switzerland-based Roche’s second-biggest seller with $6 billion in sales last year, according to data compiled by Bloomberg.
The institute’s report found regulators in developing countries have problems meeting international standards and tracking medical products. Companies such as Wal-Mart Stores Inc. (WMT:US) and ConAgra Foods Inc. (CAG:US) control the food market and can trace those supplies. During the heparin crisis, neither the FDA nor Deerfield, Illinois-based Baxter was able to recreate the supply chain, taking weeks to get close to the source, according to the report.
The FDA should share inspection reports with countries that have strict regulatory standards, such as European inspectors, to avoid duplicating work “especially when a vast number of facilities go uninspected,” the institute recommended. The agency also should help developing countries improve surveillance, such as searching for adverse events at hospitals, and facilitate training of international regulators.
The FDA inspected 424 foreign drug facilities in fiscal 2009, compared to 1,015 domestic establishments the same year, according to a September report from the Government Accountability Office, the investigative arm of Congress. The FDA opened an office in China in 2009. President Barack Obama’s fiscal 2013 budget includes $10 million for 16 inspectors who will be stationed in China, Patrick McGarey, assistant commissioner for budget, said in February when the proposal was released.
In all, the institute’s report makes 13 recommendations that also include partnering with businesses to create frugal ways to help poor countries prevent fraud and track food.
To contact the reporter on this story: Anna Edney in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Reg Gale at email@example.com