Pew Research Center's study, which was released last Tuesday, concluded that, "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" (Fung). According to the report, there is now a greater potential for counterfeit or poorly manufactured drugs to reach patients given the increased amount of pharmaceutical outsourcing and illegal drug manufacturers, among other reasons.
Quoting an earlier study posted on Drug Recalls, almost 80% of the active ingredients in generic drugs sold in the U.S. are made abroad, and up to 40% of finished drugs are manufactured abroad. The FDA admits that many of these drugs are made in poorly regulated factories, which have led to many of the recent recalls.Allan Coukell, the director of medical programs at Pew Health Group, told the National Journal that, “It is clear the FDA was set up to deal with a domestic industry. 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 2008, Baxter International Inc. recalled a batch of contaminated heparin (a blood thinner made using pig intestines) that was made abroad and delivered to patients in the United States. The FDA received almost 250 reports of death, and numerous others of serious injuries in patients who were given the medication.
Following the scare with heparin, legislators pushed for new methods of improving drug safety and pharmaceutical reliability. Despite hearings and bills introduced to the Senate, no real progress has been made. Allegedly, Congress is now working on a five-year FDA reauthorization bill that would "extend the agency's authority to regulate imported drugs."
Currently, the FDA has the authority to recall food and medical devices at home, but it does not have a large presence in other countries where products are exported.
In her recent public statement, FDA Office of Compliance Director Deborah Autor said that, unfortunately, “There’s only so much the FDA can do under the current law." The Pew report recommends that, in the meantime, pharmaceutical companies should do more to regulate themselves.