The Food and Drug Administration needs much more power to protect the U.S. supply of drugs as more and more are made in other countries, the Pew Health Group reported on Tuesday.
The new study found that increased outsourcing of manufacturing, a complex and globalized supply chain, and criminals all help to create the potential for counterfeit or substandard drugs to reach patients.
Approximately 80 percent of the active ingredients in pharmaceuticals and up to 40 percent of finished drugs are manufactured abroad, the FDA estimates. Often this is in developing countries with little or no regulatory oversight.
“It is clear the FDA was set up to deal with a domestic industry,” Allan Coukell, the director of medical programs at Pew Health Group, told National Journal. “But drugs are increasingly manufactured globally and are outside of the oversight of the FDA. There is a real need to update legislation to reflect the realities of the industry.”
In 2007, a batch of contaminated heparin – a common blood thinner made using pig intestines -- made its way to the United States. Not long afterward, the FDA received hundreds of reports of serious injury and/or death in patients who were given the medication. Between January 2007 and January 2008, the FDA received 246 reports of deaths due to heparin.
Baxter International Inc., the maker of heparin, recalled the drug in the United States and several European nations.
The FDA is bound by a 1938 law that only gives the agency the authority to inspect products manufactured in the United States. “There’s only so much the FDA can do under the current law,” FDA Office of Compliance Director Deborah Autor said in a statement.
The FDA has increased inspections in the United States and abroad, and in June the agency announced a global strategy to ensure safety of imported products. Even with the global strategy, the FDA’s hands are tied when it comes to pharmaceuticals, Coukell said.
Though the agency has the authority to recall food and medical devices, it doesn’t have the regulatory power to recall drugs, nor does it have a large presence in other countries where products are exported.
“We need more FDA regulation overseas," Coukell said. "The FDA inspects domestic facilities every three years, but for facilities outside of the U.S. it takes up to nine years to get to all of them, probably longer in China. We need more foreign inspectors and more coordination with other regulators to stretch existing resources so the U.S. and Britain aren’t inspecting the same facilities.”
In addition to recommending stricter legislation and more international oversight, the Pew report also recommended pharmaceutical companies do more to regulate themselves.
Following the heparin scare, lawmakers pushed for legislation to improve drug safety. Despite hearings and bills introduced in the Senate, drug safety regulations went nowhere. Congress is currently working on a five-year FDA reauthorization bill that would extend the agency's authority to regulate imported drugs.