WASHINGTON — FDA needs the authority to keep foreign manufacturers who do not comply with regulatory requests from importing their products into the United States, agency officials are telling legislators.
Currently, the agency can stop products from entering the country only if they document they are unsafe, which places the burden of proof on FDA, rather than on manufacturers to show compliance.
Until the agency has this kind of power, its regulatory authority in this area will be more bark than bite, and foreign manufacturers will have fewer reasons than domestic ones to follow regulations, according to FDA officials.
About 80% of active ingredients found in U.S. pharmaceutical products are imported from abroad, and about 40% of finished drugs on U.S. shelves are manufactured in other countries.
“According to FDA, this trend is projected to continue and increase, with more and more of our medicine cabinets being stocked with products from countries like India and China with less robust regulatory systems than our own,” explained Sen. Tom Harkin, D-IA, at a recent Senate Health Committee Hearing. “Our challenge is to embrace the promise of this increasingly global economy while still making sure we protect American patients.”
The difficulties in policing an international drug pipeline have been highlighted by failures in recent years. In 2007, 150 U.S. patients died after taking contaminated heparin. The contamination of the blood thinner was traced to a manufacturer in China in charge of making the active ingredient in the drug.
Drug theft also has been a major problem. In 2009, 46 drug cargo thefts occurred, totaling $184 million. In March 2010, thieves broke into a warehouse and stole $75 million worth of prescription drug products, including chemotherapy agents, antidepressants and blood-thinners, which were never recovered and might have been distributed. In 2009, stolen insulin, which had lost its potency because of improper storage, was reintroduced into the drug supply, causing adverse events in patients. Counterfeit drugs also have made their way to market, including thousands of bottles of counterfeit Lipitor.
“These are some of the enormous challenges that globalization presents to FDA, pharmaceutical manufacturers, and the American public,” explained Deborah Autor, JD, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy. “At every stage of the manufacturing process there are opportunities for the drug to be contaminated, diverted, counterfeited or adulterated.”