Rules for clinical research are undergoing major changes in both the United States and the European Union. In the United States, the 21st Century Cures Act, which was signed into law on December 13, 2016, creates a new paradigm for modern trial design and clinical evidence development, and the Department of Health and Human Services has proposed significant revisions to the Common Rule, which governs human subject research. In the European Union, imminent changes to the clinical trial regulation No. 536/2014 and general data protection regulation could substantially impact the administration of clinical trials in European countries. The changes will greatly affect the conduct of clinical trials by sponsors and clinical researchers all over the world.

To find out more about these changes and how to address them in your trials, join our two-part upcoming webinar, “Conducting Multi-Jurisdictional Trials: Understanding Changes in the US and EU.” The first part, on January 24 at 11 AM EST, will feature Bethany Hills, Dianne Bourque, and Benjamin Zegarelli from Mintz Levin’s FDA practice group, who will share insights on changes that will impact the design and conduct of clinical trials in the US. The second part, on February 7 at 11 AM EST, will feature Laura Liguori and Elisa Stefanini from Portolano Cavallo, who will cover the important changes to clinical trial administration in the EU and Italy.

Register now!

Congress has four days to fund the government. The emerging spending deal could include any number of legislative priorities. We wait and see for signs that a spending deal is close before we start envisioning what a short-term continuing resolution might look like. Both sides will have to agree in order to avoid the shutdown. We also will be following the Senate Finance Committee as it votes to advance the nomination of Alex Azar to the full Senate for consideration. You can read about this and more in our health care preview.

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary. Mr. Azar was more recently an executive at Eli Lilly and Company. As summarized here, Mr. Azar received many questions regarding Medicaid, CHIP, the Affordable Care Act, and most notably and often, drug prices. Continue Reading Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices

This week, Congress returns to D.C. with 11 days to pass a government funding bill that may touch on issues such as CHIP, the minibus, DACA, and disaster relief. How this all comes together by January 19th will start to play out this week. Meanwhile, the Senate Finance Committee will consider the nomination of Alex Azar to be the Secretary of the Department of Health and Human Services (HHS). We cover that and more in our preview, which can be found here.

2017 was an eventful year for health care, and now we can all sit back and relax with very little concern that major health policy will be on the table in 2018. Right?

Not so fast. Talks of entitlement reform, upcoming regulatory action in Medicare, Medicaid, FDA and the Marketplace, and let’s not forget the still lingering health care minibus. Lots to do in 2018 and we are just getting started.

Read the ML Strategies 2018 Health Care Preview to get our take on where things will go in 2018.

 

The U. S. Department of Justice (DOJ) issued a memo dated January 4, 2018 regarding federal marijuana enforcement policy, directing all U.S. Attorneys to enforce the laws enacted by Congress and to follow well-established principles when pursuing prosecutions related to marijuana activities.  Attorney General Jeff Sessions’ memorandum rescinds multiple guidance documents issued during the Obama administration, such as the Cole Memo  dated August 29, 2013, and announces a” return to the rule of law.”  Continue Reading Sessions Memo Resets Federal Marijuana Enforcement Policy

Republicans enter this week on target to pass a sweeping tax reform package after securing support from Senators Corker (TN) and Rubio (FL). Additionally Susan Collins (ME) applauded the “inclusion of multiple amendments,” but stopped short of publicly supporting the measure. Senator Collins’ vote and the commitments she receives in exchange for her vote remains a pivotal piece to forecasting the week and months ahead, particularly for health care matters. For the complete preview, please click here.

A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical. This bill follows significant, high-profile data breaches by Uber and Equifax, both of which involved millions of individuals (87 million and 145 million, respectively) and both of which went unreported for a significant period of time following discovery by the companies. Equifax took more than a month to notify the public, while Uber took more than a year. Continue Reading Proposed Law Would Criminalize Failures to Report Data Breaches

This week, Republicans will ramp up efforts to pass a tax reform package. We should also get signs that a year-end spending deal is coming together. How things play out this week — both inside and outside the Beltway — will have implications for taxes, health care, and funding the government. For the complete preview, please click here.

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D  Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. (Those interested in a high-level overview of the Proposed Rules should see our post from last month). Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic