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
Report on Research Compliance 17, no. 1 (January 2020) - ? A man from Richland, Washington, is facing life in prison after being convicted of 47 counts of fraud for staging clinical trials that purportedly enrolled dozens of...more
Outlook for This Week in the Nation's Capital - Recess. The House and Senate remain in recess until after the election and will return on November 13....more
Outlook for This Week in the Nation's Capital - Fall Agenda. With the Kavanaugh confirmation completed, Senate Republicans want to quickly begin confirming additional circuit court nominees....more
Outlook for This Week in the Nation's Capital - Kavanaugh Vote. The Senate was previously planning to tee up the final vote on Kavanaugh over the weekend, but the vote on the floor has been delayed a week to accommodate a...more
Highlights this week: The Senate will give the final OK to opioids legislation, HHS gets full-year funding for the first time in forever, new bipartisan legislation would allow FDA to update labels on older generic drugs, and...more
Outlook for This Week in the Nation's Capital - Senate Appropriations. The Senate is planning to begin work today on its minibus package that contains the defense and labor, health, and education appropriations bills. ...more
Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next...more
LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION - The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...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
Outlook for This Week in the Nation's Capital - Appropriations on Senate Floor. This week, the Senate plans to take up a three-bill appropriations package, commonly referred to as a “minibus”, including Military...more
Foley’s Bipartisan Public Policy Team is pleased to share our “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. *Please note that we publish this newsletter only...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
Outlook for This Week in the Nation's Capital - Farm Bill Re-vote? Last week’s vote on the farm bill failed after the Freedom Caucus refused to support the measure. A roll call vote on the motion to reconsider was postponed...more
CONGRESS RECONVENES, WITH A FOCUS ON OPIOIDS - Lawmakers return today to Capitol Hill after a two-week recess, and multiple committees in both the House and Senate are poised to examine the opioid crisis and potential...more
The Trump Administration on Feb. 12 released its Fiscal Year (FY) 2019 budget request, titled "An American Budget." Unlike last year's budget, which was released in late May, the release of this budget conforms to the typical...more
Drug overdoses are now the leading cause of death for Americans under the age of 50. Of the drugs contributing to these deaths, prescription opioids, heroin, and the synthetic opioids, such as fentanyl, have risen...more
Lawmakers returning to Capitol Hill this week after the Thanksgiving recess face a daunting series of tax and budget deadlines that will set the stage for how Congress addresses year-end healthcare priorities. That...more
Short-term Continuing Resolution Likely Needed to Fund Government Past December Deadline: Republicans are focused on tax reform through Thanksgiving, and when lawmakers return from the upcoming holiday recess, they will have...more
On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more