The U.S. House of Representatives Tuesday passed, by voice vote, a bill that would reauthorize for the second time the Pandemic and All-Hazards Preparedness Act (PAHPA), which funds the nation's emergency stockpile of medical products, the development of medical countermeasures and responses to infectious diseases and pandemic flu. Under H.R. 6378, the pandemic flu and emerging infectious disease programs would each receive $250 million a year in supplemental funding from 2019 through 2023. The bill also improves the existing emergency health fund, as it would allow the Department of Health and Human Services to respond to an emergency without having to wait for a congressional vote, said Rep. Susan Brooks (R-Ind.), a sponsor of the bill. Noting that PAHPA will sunset Sunday unless it's reauthorized, Rep. Greg Walden (R-Ore.), chairman of the House Energy and Commerce Committee, urged the Senate to hurry up and pass the House version. The Senate Health, Education, Labor and Pensions Committee passed its own bill to reauthorize PAHPA in May, but the full Senate has yet to act on it. (See BioWorld, May 24, 2018.)
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) issued new restrictions Tuesday on the use of Leverkusen, Germany-based Bayer AG's Xofigo (radium Ra 223 dichloride) due to an increased risk of fracture and a trend for increased mortality seen in a clinical trial. Under the restrictions, Xofigo is now only authorized for use in the U.K. in patients with symptomatic bone metastases and no known visceral metastases who have had two previous systemic treatments for metastatic castration-resistant prostate cancer or who cannot receive other systemic treatments. It is not to be used in combination with abiraterone acetate and prednisone/prednisolone. The MHRA also advised medical professionals of issues with Cambridge, Mass.-based Biogen Inc.'s Spinraza (nusinersen) and Zinbryta (daclizumab). The agency said reports of communicating hydrocephalus have been associated with Spinraza, a blockbuster treatment for spinal muscular atrophy that was developed in partnership with Ionis Pharmaceuticals Inc., of Carlsbad, Calif. Doctors should urge their patients and their caregivers to seek immediate medical attention if any signs or symptoms of communicating hydrocephalus develop during their treatment with Spinraza. As for multiple sclerosis drug Zinbryta, which Biogen developed with Abbvie Inc., of North Chicago, the MHRA cautioned doctors to continue monitoring patients for immune-mediated encephalitis for 12 months after the drug has been stopped. Earlier this year, the EMA suspended the marketing authorization for Zinbryta, citing three deaths that were linked to immune reactions caused by the drug and eight reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis. (See BioWorld, March 8, 2018.)
The U.S. Department of Health and Human Services (HHS) Monday canceled a $15,900 contract between the FDA and Advanced Bioscience Resources Inc. (ABR), of Alameda, Calif., involving the supply of human fetal tissue to develop testing protocols. In terminating the July contract, HHS questioned whether it included the appropriate protections for fetal tissue research or met procurement requirements. Noting "the serious regulatory, moral and ethical considerations involved," HHS said it will audit all acquisitions of human fetal tissue within the department and review all research involving fetal tissue to ensure it complies with statutes and regulations. The department also committed to accelerating and funding efforts to review whether adequate alternatives exist to the use of human fetal tissue in HHS-funded research. The announcement came a week after 85 members of Congress wrote to FDA Commissioner Scott Gottlieb reminding him that ABR is under investigation for violating federal law that prohibits the buying and selling of human fetal tissue. Citing the "unresolved questions" raised in congressional investigations, the lawmakers said, "We are alarmed that the FDA has continued to award contracts to ABR for the procurement of human fetal tissue. . . . We urge you to cancel this contract immediately and utilize alternative, modern scientific techniques that do not contribute to the trafficking in baby body parts."
The NIH's Undiagnosed Diseases Network (UDN) entered phase II this week, growing from seven clinical sites to 12, as five more academic medical centers were added to the network. The UDN brings together top clinicians and researchers and uses cutting-edge technologies, such as genomic sequencing, metabolomics and assessment of patient variants in model organisms, to bring better understanding to the cause of extremely rare diseases and accurately diagnose rare conditions. Since the network opened to applications three years ago, it has diagnosed more than "200 cases that had long been mysteries to the medical community," according to NIH. Phase II also includes new research cores – a metabolomics core at Mayo Clinic, of Rochester, Minn., and a model organisms screening center at Washington University, of St. Louis.