In a letter to Congress, he says the agency lacks "explicit jurisdiction" in other countries hampers its ability to inspect facilities and investigate manufacturers that violate US laws. And Leavitt called for legislation to give the FDA jurisdiction abroad. The letter was sent to Republicans on the House Committee on Energy and Commerce,Bloomberg News reports.
"Current law has not kept up to date with modern technology and global marketing realities,'' Leavitt wrote in his letter, which was sent to Republicans Joe Barton of Texas and John Shimkus of Illinois. "An amendment would better enable FDA to address criminal conduct that occurs entirely outside of the United States and threatens the health and safety of consumers within the United States.''
The FDA is under fire after a series of episodes in which various meds, pet food, seafood and toys imported from China were found to be tainted with harmful chemicals in the past year. Earlier this week, FDA officials disclosed that they failed to inspect a Chinese plant that makes an ingredient in a blood thinner that has been tied to life-threatening side effects because of a mix-up in paperwork.
The FDA conducts annual inspections of about 7 percent of overseas drugmakers that ship to the US, a pattern suggesting the FDA would take 13 years to visit them all, according to a report by the Government Accountability Office, the investigative arm of Congress, Bloomberg notes.
A White House task force headed by Leavitt called for a new approach to protecting against tainted imports of food and other products in September. The government needs to better identify which imports are most likely to be contaminated and require the most intense review, according to the panel.
The FDA wants to station employees in five regions of the world to improve the safety of exports of food and drugs, agency Commissioner Andrew von Eschenbach said on Jan. 24.