NDAA Proceeds with Plan for DoD Drug Approval Panel

The Department of Defense (DoD) and the Food and Drug Administration (FDA) have signed off on a potential fix to a controversial provision within the National Defense Authorization Act (NDAA). While the NDAA will still includesa broadly written provision to grant the Defense Department broad powers to deploy products like freeze-dried plasma that have been held up by the FDA, the agencies and relevant lawmakers tentatively settled on using a separate legislative vehicle to override the controversial provision. The new language, backed by the Senate HELP and House Energy and Commerce committees (those with jurisdiction over the FDA), is modeled on compromise language that the panels proposed days ago and would instead require the FDA to expedite reviews upon DoD request, among other measures.

Thus, the underlying NDAA, which will be considered later this week, will still contain a provision (section 732 of Senate’s version of the NDAA, H.R. 2810)which would allow the DoD to have its own drug and device approval process, amidst a disagreement with the Food and Drug Administration (FDA) over the approval of freeze-dried plasma. The Pentagon argued that the product, which has not been approved beyond limited use by the FDA, improves the chances of survival for military personnel on the battlefield. The FDA says that full approval could come as early as next year. Public health experts, including five former FDA commissioners, argue that creating a new process could undermine the safety and effectiveness of products used for the armed forces. Previously, Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee Lamar Alexander (R-Tenn.), along with Sen. Richard Burr (R-N.C.) and Chairman of the House Energy and Commerce Committee Greg Walden (R-Ore.), have voiced concerns with the FDA-related provision.

Judiciary Committee Investigates Allergan and Sovereign Immunity

The House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet held a hearing last week on the legitimacy of an agreement between pharmaceutical manufacturer Allergan and a Native American tribe, which agreed to exclusively license six patents for the eye drug Restasis back to the company in exchange for ongoing payments. Allergan claims that as a sovereign entity, the tribe places the patents outside the jurisdiction of the U.S. Patent Trial and Appeal Board. A challenge to the patents brought by a rival company is pending before the board. Allergan claims that the Board’s process is flawed and unfair, and that the patents should be reviewed in federal court. During the hearing, Committee members heard testimony from four patent law experts. Chairman Bob Goodlatte (R-Va.) expressed concerns that the use of sovereign immunity to serve the interests of private companies unrelated to the tribes weakens the intellectual property system as a whole.

Lawmakers Urge Inclusion of UDI in Claims

Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) have requested additional information about the Centers for Medicare and Medicaid Services’ (CMS) position on the inclusion of unique device identifiers (UDIs) on Medicare claim forms. In a letter to CMS Administrator Seema Verma, the lawmakers outline conflicting statements made by CMS on the issue. They argue that it is “essential that the Medicare system support the post-market surveillance of risky medical devices, both to improve patient care and to support program integrity.” The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) has previously recommended that the UDI information be included on Medicare claims.

Lawmakers Request Report on ID Modeling

House Energy and Commerce Committee leadership have written to the Government Accountability Office (GAO) to request a review of how the federal government uses predictive models to inform decision-making. The GAO recently reported that models could accurately predict infectious disease outbreaks and allow for better planning and deployment of public health resources. Chairman Greg Walden (R-Ore.), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-N.J.), and Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-Colo.) request that the GAO conduct an additional study to assess the challenges in conducting emerging infectious disease modeling, which could include a lack of sufficient data and methods.

WHO Updates Antibiotics Policy, E&C Requests Info on Superbugs

The World Health Organization (WHO) issued a statement on Tuesday urging a reduction in the use of medically important antibiotics in food producing animals and a complete restriction on the use of antibiotics to promote growth or deter disease without diagnosis. According to WHO, sick animals should be treated with the drugs “least important” to human health. The organization believes such actions are necessary to reduce antimicrobial resistance across the globe. The U.S. Department of Agriculture has responded that the WHO guidelines do not align with U.S. policy and are not backed by sound science.

Leadership on the House Energy and Commerce Committee have written to the Government Accountability Office (GAO) requesting that the agency study the epidemiology of superbugs in order to ensure the nation’s preparedness to respond to strains of bacteria resistant to several types of antibiotics. The letter was signed by Chairman Greg Walden (R-Ore.), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-N.J.), and Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-Colo.).

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