In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Report on Research Compliance 18, no. 4 (April 2021) - Following social injustice protests over police brutality against Black people and the health disparities accelerated by the COVID-19 pandemic, an advisory committee...more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
The National Institutes of Health (NIH) has warned clinical trial sponsors – including not only drug and device companies, but also universities and hospitals with investigator-initiated trials – to submit significant...more
On January 9, 2020, the Civil Division of the U.S. Department of Justice (DOJ) announced that it recovered over $3 billion from civil False Claims Act (FCA) judgments and settlements in the fiscal year ending September 30,...more
HOUSE OKs DOZENS OF OPIOID-RELATED BILLS; MORE VOTES SCHEDULED - The House last week approved 38 bills that lawmakers hope will stem the opioid epidemic, and it scheduled votes this week on at least a dozen more....more
As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of...more
Congress moved one step closer to avoiding a government shutdown on Feb. 6, voting overwhelmingly (245-182) to pass a short-term, GOP-backed government funding bill (text; section-by-section) that would keep the federal...more
Although smaller community hospitals may provide treatments that are as good and as safe, Americans flock to academic medical centers for specialized care and complex procedures. They’re lured to the big, pricey institutions...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more
President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. "Precision Medicine"...more
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more