Healthcare supply chain experts say it remains to be seen whether a new memorandum of agreement between China and the U.S. will improve the quality and safety of drugs and medical devices traded between the two countries.
Some industry executives said the agreement is a first move but doesnt address all the concerns about the importation of devices and drugs from China. The scope of (the agreement) is baby steps, said Natasha Leskovsek, an attorney and Food and Drug Administration regulations expert with the law firm Heller Ehrman. A lot of the (regulatory) emphasis has been placed on food safety, and theres only a select number of drugs and devices addressed in the safety agreement.
Supply chain executives have been concerned about import quality since recalls of products this past summer, prompting HHS to announce plans to create and sign the memorandum of agreement by year-end (Oct. 22, p. 29).
The memo signed last week by HHS Secretary Mike Leavitt and Shao Mingli, commissioner of Chinas State Food and Drug Administration, is a bilateral agreement holding the two countries to similar product-oversight and information-sharing policies. Under the agreement, China will require its drug and medical-device manufacturers to register with the SFDA, and both countries food and drug agencies will share information on approvals, inspections and enforcement actions taken against manufacturers.
The deal, which follows five months of negotiations between the two governments, came amid intense public pressure on federal officials to strengthen the FDAs authority to monitor imported consumer products, particularly those from China. Last summer, the FDA recalled a variety of faulty consumer goods manufactured in China, including pet food, toothpaste, toys and cough medicine. The safety issuessome life-threateningwere of particular concern to U.S. hospitals, which worried contaminated products could end up in their supply chains.
The 10-page agreement adds quality measures into early-stage production, and adds to information sharing and oversight capabilities (See chart).
The list of products coming from China includes the cholesterol drug atorvastatin, the erectile-dysfunction drug sildenafil, glucose strips and condoms. U.S.-manufactured products include insulin drugs, penicillin, intraocular lenses and pacemakers.
But despite officials work to hammer out the agreement, some supply-chain experts question whether the new regulations are rigorous enough to prevent a recurrence of the types of problems seen last summer.
Blair Childs, spokesman for group purchasing organization Premier, said the safety memo is a very modest start, and he said he doesnt see a lot of immediate reassurance for hospitals concerned about supply-chain safety. I think theyll react by thinking that the U.S. and China are making some progress, but that its not enough, Childs said. I think hospitals are concerned about ensuring the safety of their patients, and theyre anxious to see more from this agreement.
Jeff Lerner, president and CEO of the ECRI Institute, a not-for-profit clinical and healthcare supply-chain research organization, believes the agreement pays scant attention to hospitals concerns over medical device safety. Only four devices total were identified for increased oversight, and neither of the items on the U.S. listcondoms and glucose test stripsare typically on hospitals supply lists. The agreement doesnt really have much to do with what hospitals use, Lerner said, so it really has no impact one way or another on their concerns.
Linda Bentley, an attorney and FDA specialist with law firm Mintz Levin Cohn Ferris Glovsky and Popeo, said, however, that the agreement does include plans and a timetable for phasing in greater regulation and oversight of additional drugs and medical devices exported by each country. Its a promising development, but the agreement will only be as effective as the parties are in implementing the measures, Bentley said.