FDA issues progress statement on cooperation with China
WASHINGTON U.S. Secretary of Health and Human Services Mike Leavitt on Wednesday signed a Joint Progress Statement with Li Changjiang, minister of the general administration of quality supervision, inspection and quarantine of the People’s Republic of China that outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement on food and feed safety.
“Today’s progress report reflects strong and sustained cooperation by both nations to strengthen the safety of food products exported to the United States from China,” Leavitt said. “I’m very pleased with our efforts and commend our Chinese counterparts for their commitment to this important work.”
The statement describes progress in several important areas:
- Establishment of a mechanism for cooperation on significant events related to food and feed safety, including designated points of contact, emergency contacts, and thresholds for notifications; enhancing the exchange of information on the safety of food and feed safety; and developing a better understanding by both sides of each others’ respective regulatory systems.
- Development of concrete steps that will lead to a system whereby AQSIQ will electronically certify to FDA that specific products sent for export to the United States meet FDA standards for safety and manufacturing quality.
- Focus efforts on inspections and supervision and laboratory testing standards to ensure food and feed safety. The United States agreed to conduct training for Chinese officials on U.S. regulatory standards and requirements.
- Establishment of a cooperative mechanism to notify each other of significant risks to public health related to product safety or the gross deception of consumers, and to share information to facilitate each other’s investigation.
The parties are meeting this week in Annapolis, Md., as part of the fourth session under the United States-China Strategic Economic Dialogue.
The MOA, signed during the third session under the SED in December of 2007, established a bilateral mechanism to provide greater information and other assurances to enhance the safety of food and feed products traded between the two countries. Since its signing, HHS’ Food and Drug Administration and AQSIQ have planned a joint implementation work strategy and have begun the initial steps called for under the agreement.
CDER responds to Senator’s inquiry
WAHSINGTON As the Food and Drug Administration prepares its response to the question from Sen. Sherrod Brown, D-Ohio, on how best to hold drugmakers accountable for drug quality, the Center for Drug Evaluation and Research’s Office of Compliance is highlighting the agency’s efforts to examine the drug supply chain, reiterating regulations that the New Drug Application holder is responsible.
“Ultimately the dosage form manufacturer with its name on the label is responsible,” the Office of Compliance said. “Our regulatory structure under the [Food, Drug and Cosmetic] Act, and implementing regulations, provide for the identity, strength, quality and purity of the drug and the prohibited acts provide for civil sanctions and criminal penalties for failure to do so.”
The office commented on the best way to hold firms accountable for drug quality incidents, such as the heparin contamination, in which the manufacturer complies with FDA regulations—passing inspections and conducting U.S. Pharmacopeia tests on incoming products—but unknowingly distributes adulterated drugs anyway.
“In light of the question on how to deal with incidents such as heparin, sourcing ingredients, testing and [control of the] supply stream … are important elements FDA and other regulators are examining and encouraging industry to focus on to prevent such incidents,” the Office of Compliance said.
UMB Healthcare, drugstore.com form partnership
BELLEVUE, Wash. UMB Healthcare Services, a division of UMB Financial Corporation, and drugstore.com on Tuesday launched a new partnership to provide a growing number of UMB Health Savings Account holders direct access to eligible products for the tax-advantaged health plans.
The UMB HSA account access website provides a direct link to the customized HSA store on drugstore.com. Once there, account holders will have access to HSA-eligible products, services that automatically track purchases and provide an HSA-only receipt, and additional resources to help Consumer- Directed Healthcare Plan users record expenses for tax purposes. UMB HSA account holders will also receive special money-saving offers from drugstore.com, the companies reported.
“We’re pleased to work with UMB to provide their growing number of customers the convenience of shopping in one online location with a wide selection of more than 3,000 HSA-eligible, over-the-counter products as well as prescription medications and contact lenses,” stated David Lonczak, vice president and chief marketing officer, drugstore.com. “Unlike brick-and-mortar stores, the online retail environment is uniquely qualified to provide a convenient solution with eligible products as well as record keeping services for HSA account holders.”
UMB Healthcare’s HSA accounts grew even faster than the national average last year, according to the health insurer, surpassing $100 million in assets at the end of 2007.
The number of people with HSA/High Deductible Healthcare Plan coverage rose to 6.1 million in January 2008, a 35 percent increase over the previous year. In January 2007 there were 4.5 million people with HSAs and HDHPs and 3.2 million in January 2006, according to America’s Health Insurance Plans.
“UMB Healthcare HSA accounts give customers the opportunity to take control of their healthcare dollars while also saving money,” stated Dennis Triplett, president of UMB Healthcare Services. “The partnership with drugstore.com provides a great customer benefit, as it offers our account holders a convenient and streamlined process for managing their health care purchases.”
In addition to HSA accounts, UMB supports Flexible Spending Accounts and Health Reimbursement Arrangements (HRAs). UMB Healthcare Services was one of the first financial partners to provide multi-purpose card technology to the health care industry and recently developed a Healthcare Line of Credit product.