U.S. seeks details of supply chains for foreign drugs

WASHINGTON (Reuters) - U.S. regulators are asking drugmakers to submit more details about their supply chains under a pilot program announced on Wednesday to help protect patients from fake or tainted medicines from overseas.

Companies that voluntarily provide the information can get the products through U.S. border entry points more quickly, Food and Drug Administration officials said.

Concern about imported drug ingredients grew last year after the deaths of patients given tainted supplies of the blood-thinner heparin made in China. More than 80 percent of active drug ingredients are produced abroad.

The FDA is hoping to encourage companies to provide evidence they are tracking every step of manufacturing to ensure safety.

“We’re asking for a very robust and comprehensive description of the process by which the products come into the country,” Steve Silverman, assistant director in the compliance office of the FDA’s drugs center, said in an interview.

If companies submit their medicines to the test program, inspectors at the border can focus on other medicines that may be risky, the agency said.

The FDA said it would choose 100 applicants that can submit up to five drugs each under the pilot program, which would run for two years. Officials would then decide whether to expand it.

(Reporting by Lisa Richwine; editing by Leslie Gevirtz)


Related Posts:

NEW YORK (Reuters) - The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration’s top worries and is changing how the agency weighs new medicines, a top FDA official said on Tuesday. The agency is thinking about how to weigh such possible side effects

Full Post: Drugs’ heart risk is FDA’s biggest worry: official

WASHINGTON (Reuters) - Drug companies should more thoroughly study the potential heart risks of new diabetes medicines, U.S. health officials said on Wednesday. The Food and Drug Administration, in new guidelines, outlined steps companies should take “to ensure that a new therapy does not increase cardiovascular risk to an unacceptable extent.” (Reporting by Lisa Richwine; Editing by

Full Post: FDA wants more study of diabetes drug heart risk

WASHINGTON (Reuters) - The U.S. Food and Drug Administration, hampered by increasing globalization and a rise in complex products, may not be able to adequately protect the public’s health, the watchdog arm of Congress said in new findings released on Thursday. “As a result, the American consumer may not be adequately protected from unsafe and ineffective

Full Post: Report cites FDA’s weaknesses over drugs, devices

WASHINGTON (Reuters) - U.S. regulators need to improve lax oversight of the financial conflicts of doctors who test medicines before they are approved for sale, a government watchdog report said on Monday. The Food and Drug Administration lacks a complete list of doctors conducting research on new medicines and cannot determine which companies have submitted financial

Full Post: Watchdog finds lax U.S. oversight of doctor conflicts

By Lucy Hornby BEIJING (Reuters) - U.S. officials opened the first overseas Food and Drug Administration office in Beijing on Wednesday as they gear up for a long battle to ensure the quality of food, drug and feed imports from China. The eight FDA workers in Beijing, Shanghai and Guangzhou will set up a process for pre-certifying

Full Post: U.S. says food, drug inspection access in China improving

Site Navigation

Most Read


Most Read


  • kinwrite.com@gmail.com