科技界要求国会改进医疗器械管理规范

幸福侠侣

最近美国生物医疗器械公司Edwards Lifesciences公司的CEO Mike Mussallem在国会众议院商务与能源委员会会议上公开批评美国现有管理体制制约了更多更好的医疗器械产品进入市场。他还举例称美国是第42个批准本公司开发的人工心脏瓣膜的国家。Mike Mussallem表示，长期以来美国良好的科研环境和健全的管理机制都促进了美国的科技创新，然而近年来这种良好的环境正逐渐被落后的管理和支付体制所侵蚀。

尽管他赞扬了FDA近年来为了加速相关产品的审批所作出的努力，但是他还是呼吁国会对目前的管理方式进行一个合理的调整。例如他提到在医疗器械上市后会有一个数据注册的阶段，这一阶段的初衷是能够收集第一手的用户使用数据进而对医疗器械的安全性和有效性进行实时跟踪和改进。然而这一流程过于繁琐的程序使得许多外科医生对新医疗器械产品望而却步，违背了数据注册这一规定的初衷。同时为了维持这一程序，器械制造商和医院都会承担不小的开支，这也为这一程序是否能达到其预想效果提出了质疑。同时他还指出现有的医疗保险在支付时间上的延迟也导至医疗器械推广的阻碍。

基于以上几点，他呼吁美国国会及有关部门正视这一问题，为未来美国医疗器械发展提供更好的土壤。（生物谷Bioon.com）

详细英文报道：

Edwards Lifesciences ($EW) CEO Mike Mussallem advocated for a more efficient regulatory and reimbursement system for medical devices before the congressional House Committee on Energy and Commerce yesterday, pointing out that the U.S. was the 42nd country to approve the Irvine, CA-based company's Sapien artificial heart valve for frail, high-risk patients.

"The balanced ecosystem that has supported innovation in the U.S. is being eroded by an increasingly costly and cumbersome risk-averse culture in our regulatory and payment systems," he told the committee members, according to his prepared remarks.

However, the CEO praised FDA for issuing a number of guidance documents over the past year on topics including priority review for premarket submissions, expedited access for certain devices requiring a PMA and balancing premarket and postmarket data collection.

"The biggest issue here is that FDA needs the resources and support to move faster on these initiatives. Drs. Hamburg and Shuren have a complex bureaucracy to manage, and they need the mandate to make change quickly. Congress could lend support to FDA by providing additional resources to FDA to help expedite these changes and give them room to innovate," he said.

Mussallem devoted a large part of his speech to post-market regulations and review via data registries. "When registries are done right, they can yield extremely useful information about patient outcomes and device benefits," he said, adding that Edwards benefited from the transcatheter valve therapy registry created by the Society of Thoracic Surgeons and American College of Cardiology; the information helped to expand the indications of Sapien, making it available to a wider audience.

But the registry has resulted in tradeoffs: "Many physicians have told us that it takes longer to fill out the TVT Registry form than it does to perform the procedure," he said.

"In addition to the significant financial commitment manufacturers must make to support the development and ongoing operations of registries, hospitals are charged ongoing fees to participate. In a time of extreme budget pressure, we need to ensure that this process is not so costly and burdensome that the long-term prospects of the registry diminish over time," he continued. To achieve the right balance, Mussallem recommended following AdvaMed's principles on medical device data registries.

Data dissemination is another area of concern with registries, he said: "Too often, well-intended advocates have driven sensational headlines, citing cherry-picked data or anecdotal incidents that have received outsized attention."

Finally, on the economic incentives and reimbursement front, he testified that accountable care organizations and bundling payment models, if implemented successfully "could help ensure that patients receive better-coordinated and higher quality care, while also restraining rising costs. If implemented poorly, hospital value-based purchasing strategies could tilt toward simply restricting access and creating new barriers for patients and physicians as they seek advanced, clinically appropriate care."

He urged the Centers for Medicare and Medicaid Services to use its Coverage with Evidence Development protocol judiciously. "CMS should be careful that CED does not become more of a burden to patient access than a tool for data development, particularly in cases wher sufficient clinical evidence has already been developed--if so, the evidence requirement simply adds unnecessary time and cost," he said.

Today, the head of FDA's device arm, CDRH, and leaders from healthcare companies including Abbott are testifying to the committee, as part of the 21st Century Cures initiative, chaired by Rep. Fred Upton (R-MI).