The U.S. FDA said it is evaluating new information regarding the risk of type III endoleaks associated with the Endologix AFX endovascular graft when used to treat abdominal aortic aneurysm. The agency said data recently presented at a medical society meeting suggests that the risk of type III endoleaks is higher than previously appreciated for the AFX2 and AFX with Duraply grafts. In an accompanying press release, the agency said that endoleaks are a risk with any endovascular graft and that many such events are asymptomatic. The FDA is recommending yearly follow-up for patients with the implicated devices for the duration of their lives. Endologix Inc., of Irvine, Calif., ceased manufacture of the AFX with Strata materials in July 2014, and the agency said the new data suggests a cumulative increase in the risk of additional procedures of 2.5% associated with the AFX line of grafts. However, those data include only 32 patients with the AFX2 and 197 with the Duraply AFX, and the agency acknowledged that the limitations of those data include the small absolute numbers of patients. The agency intends to continue its surveillance of the devices, but indicated it will cull data on other endovascular graft devices as well.
The FDA said it will hold an Oct. 29, 2019, webinar to review the agency's collaborative community initiative and to review the collaborative communities toolkit. The webinar will dover the definition of a collaborative community and the requirements for participation.
Donald Tusk, president of the European Union, said via Twitter that the EU has agreed to an extension of the deadline for the U.K.'s exit from the EU, dubbing the extension a "flextension" that will expire Jan. 31, 2020. Tusk said the decision will be formalized via a written procedure, while the U.K. is able to finalize the so-called Brexit at any point in the meantime so long as it does so under the terms of the existing agreement.
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), said the effort on the part of the state of Illinois to shut down the Medline ethylene oxide (EtO) plant in Wauekegan, Ill., "will likely have a direct and devastating effect on the patients" served by the 135 hospitals located in that state. Whitaker said the effect will extend to hospitals in other states as well, adding that among those affected will be "the most vulnerable newborns" cared for in neonatal intensive care units across the U.S. The Illinois state legislature has scheduled a hearing Oct. 29 to discuss legislation that would force hospitals and device sterilization facilities to phase out their use of EtO, and Advamed quoted the March of Dimes in stating that nearly 300 babies are born prematurely in Illinois each week. In an Oct. 28 press release, Advamed quoted FDA's Suzanne Schwartz as saying that any EtO plant closures beyond those previously announced "will have a ripple effect nationally."
The U.S. Government Accountability Office (GAO) said other federal government agencies vary in their practices as to how they deal with duplicate comments to the docket for proposed rules and guidances. GAO said federal government agencies publish on average roughly 3,700 proposed rules and guidances annually, although "some high-profile rulemakings have received extremely large number of comments." The situation raises questions about how those agencies go about identifying the sources of those comments, although the Administrative Procedures Act does not stipulate the disclosure of identifying information. Some agencies collapse duplicate comments into one file and denotes the number of such comments received, GAO said, but the variation in federal agency policy clouds the questions of the identities of commenters and how many individuals commented to a given docket.
The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services said the Centers for Medicare and Medicaid Services (CMS) could improve its approach to reporting recoveries of monies under the Fraud Prevention System (FPS). OIG said in an Oct. 28 report that the CMS report of such recoveries after three years gave stakeholders "an incomplete picture" of the value of the FPS because the "overwhelming majority of the identified savings from payment recovery administrative actions have not been recovered." OIG recommended that the CMS employ a uniform methodology for program integrity contractors to use when reporting estimates for the value of law enforcement referrals, a recommendation with which the CMS is said to have agreed.