On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight...more
On June 19, 2019, in a 4-3 decision favorable to Ohio consumer interests, the Ohio Supreme Court reversed the Public Utilities Commission of Ohio’s (PUCO) order that allowed FirstEnergy to collect between $168 million and...more
In a decision last week that could affect $12 billion that insurers assert is owed by the federal government, the Federal Circuit decided that HHS was not required to pay amounts required by statute because Congress had...more
In recent guidance, we wrote about what companies should do to minimize the risk of federal criminal penalties when doing business with or investing in cannabis industry companies. One principle we stressed is the need to...more
Over the past month, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program and Medicare Therapy Caps. In this post we will go into...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more
Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance...more
In a recent post, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program. In this post we will go into detail on the background and...more
We are half way through May – are we having fun yet? There is a lot of activity this week in addition to ongoing talks in the Senate regarding their version of the American Health Care Act. The reauthorization of FDA User...more
On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more
In a recent post we noted that the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program is one of the many potential riders on the health care minibus. In contrast to an omnibus bill, the “minibus” refers to a...more
The House Appropriations Committee released the 2017 Omnibus Appropriations bill on May 1 as part of the fiscal year. Congress decided to continue the 2015 rider[1] that prohibits the Department of Justice from spending funds...more
Welcome to Spring Break! That time of the year where college kids head to a beach somewhere, families pack up for some tourist trap to spend lots of money, and Congress gets out of DC and goes back home. This is also a time...more