Lost among reports of the first locally transmitted cases of the Zika virus in the continental United States in late July (as well as concern over Zika transmission at the 2016 Summer Olympics in Rio de Janeiro, Brazil in...more
On September 6, 2016, 61 members of the Florida House of Representatives issued a letter to the U.S. Department of Health and Human Services (HHS) and to the U.S. Food and Drug Administration (FDA) to urge them to: (1)...more
House Energy and Commerce Committee Chairman Fred Upton (R-MI) acknowledged publicly last week what has been widely suspected on Capitol Hill – his “21st Century Cures” medical innovation legislation will not pass Congress...more
This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more
According to Medical Device Daily, the US Food and Drug Administration (FDA) has authorized the emergency use of a diagnostic molecular test developed by Quest Diagnostics subsidiary, Focus Diagnostics Inc., in response to...more
FY17 Appropriations - The House and Senate Appropriations Committees continue to move forward on individual FY17 spending measures based on discretionary spending levels enshrined in last fall's bipartisan budget deal....more
Additional guidance documents are expected. The US Food and Drug Administration’s (FDA’s) first quarter of calendar-year 2016 has been a busy one on the medical device front. FDA’s Center for Devices and Radiological...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more
This Week: Medicaid program takes financial hits as the House looks for “savers” and acts on a budget... while the Senate sees no reason to do a budget... The Senate focuses on ACA oversight and mental health and opioid abuse...more
This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more
This Week: The House and Senate were out for Presidents’ Day recess... The Senate to vote on FDA Commissioner nominee Califf after 5:30 today... Medicare Advantage rates announced....more
The Administration is Ramping Up Drug Pricing Response - The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration,...more