Federal initiatives aim to bolster health care.
Janet Woodcock, head of the Food and Drug Administration's pharmaceuticals division, said at a news conference that the project with the drug makers is designed to establish consistent quality standards for all drugs, whether brand name or generic.
The FDA has established an Office of Pharmaceutical Quality (OPQ) that will be responsible for about 10,000 decisions a year and will manage the process.
Drugs currently being evaluated for approval will remain with their existing review team at the FDA. New applications will be filed with the new office beginning immediately, Woodcock said.
Under the new structure, drug companies can expect a more integrated review and greater communication with the agency, she said.
The FDA will propose a set of quality metrics for drug makers. After a public comment period the agency will produce a final rule.
Over the past year the FDA banned numerous generic drugs from India, citing quality control problems ranging from data manipulation to sanitation. India supplies around 40% of generic and over-the-counter drugs used in the United States. Until now, Woodcock said, the FDA has only had a general sense of the state of manufacturing quality at drug manufacturers, but in the future it will have quantitative information.
Creation of OPQ was initially announced in September 2012 during a larger reorganization of the Center for Drug Evaluation and Research by Woodcock.
"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock in a 2012 memo to FDA staff. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems.
OPQ was envisioned as a way to oversee drug quality throughout the product life cycle, instead of the fragmented pre-market and post-market approach that the agency has followed for years. Woodcock said that the Office of Pharmaceutical Science, Office of Generic Drugs, Office of Manufacturing and Product Quality and Office of Compliance would all be ceding some of their quality functions to OPQ, which Woodcock has said is also meant to address several endemic problems in the pharmaceutical sector.
Meanwhile, the Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) has released "Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0." The draft document is a proposal to deliver better care and result in healthier people through the safe and secure exchange and use of electronic health information.
"HHS is working to achieve a better health care system with healthier patients, but to do that, we need to ensure that information is available both to consumers and to their doctors," said HHS Secretary Sylvia Burwell. "Great progress has been made to digitize the care experience, and now it's time to free up this data so patients and providers can securely access their health information when and where they need it. A successful learning system relies on an interoperable health IT system where information can be collected, shared and used to improve health, facilitate research and inform clinical outcomes. This road map explains what we can do over the next three years to get there."
The draft builds on the vision paper "Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure" issued in June 2014. Months of comment and feedback from hundreds of health and health IT experts from across the nation through ONC advisory group feedback, listening sessions and an online forum aided in the development of the road map.
"To realize better care and the vision of a learning health system, we will work together across the public and private sectors to clearly define standards, motivate their use through clear incentives and establish trust in the health IT ecosystem through defining the rules of engagement. We look forward to working collaboratively and systematically with federal, state and private sector partners to see that electronic health information is available when and where it matters," said Karen DeSalvo, national coordinator for health IT.
Others also expressed a positive reaction to the road map. "ONC's interoperability road map will help guide our progress toward seamless integration of electronic health record data," said Christopher Miller, program executive officer for the Department of Defense. "We are proud to be working closely with ONC and other public and private partners to ensure that our health care providers have a complete picture of health information from all sources. The availability of this information increases the medical readiness of our operational forces and enables delivery of the highest-quality care that our service members, veterans and their families deserve. We look forward to our continued partnership with ONC as we expand the safe and secure exchange of standardized health care data to improve the overall health of our nation."
Healthcare Leadership Council president Mary Grealy asserted that the benefits to patients and to the future of health care in achieving full interoperability are enormous. "A system built on accessible information and secure, meaningful data sharing will elevate health care delivery, advance quality and cost-efficiency and enable new strides in medical research. We applaud HHS and the Office of the National Coordinator for making interoperability a national priority, and we believe that, by bringing together the ideas and technological expertise from both the public and private sectors, it is a foreseeable and achievable goal," said Grealy.