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" ... The Keel-scaled boa was on the brink of extinction and it survived for over a century only on one of Mauritius’s outlying islands that is only 2 km square in area. Since the 1980s, habitat restoration and active management of this species has led to a rapid population increase of the boa and the establishment of an additional subpopulation on another recently-restored outer island of Mauritius. Before the oil spill, the global population approached 2,000 individuals by 2018 and was increasing, with the population predicted to increase further as additional island restorations took place. ... "
" ... What could the Congress do? It could direct the FDA to establish a new pathway under which truthful information outside the scope of the approved label would be able to be discussed with physicians. Dr. Schimizzi suggested in the Subcommittee hearing that the Congress require “the FDA to develop standards for qualifying [previously reviewed] data through a public process, to expand the current process of review of materials beyond what is included in the package inserts, to also cover other key data such as subpopulation, pharmacoeconomic or comparative cost data and to ensure a timely review process for such information.” The Congress also could simply declare that the FDA may not regulate the communication of truthful information, and that may (or may not) limit the Justice Department’s determination to apply the False Claims Act to cases where off label prescribing is prevalent. ... "
" ... “Yes, I recognize that there are problems with the test and with a subpopulation of patients that has lingering symptoms,” he wrote in an email, referring to what the CDC calls Post-Treatment Lyme Disease Syndrome. ... "