Tag Archives: The Health Law Year in P/Review

Prescription Drug Regulation, Promotion, And Advocacy Has Gotten More Vexing In 2017

Early 2017 has been one of the most interesting and challenging times for anyone concerned with medication regulation and evidence-based prescribing — as well as for the patients and health care professionals who will be so heavily impacted recent policy changes.

March 23, 2017

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

The Biologics Price Competition and Innovation Act creates a pathway to approve biosimilars. However, biosimilar manufacturers' avoidance of this "patent dance" could be evidence of the increased reliance on trade secrets as a protection for intellectual property.

March 10, 2017

Reproductive Health Under Assault

The outcome of the 2016 elections has set into motion an expected but nonetheless deeply damaging anti-abortion agenda that is slowly taking form in the Trump administration’s early days -- aided by the Republican majority House and Senate.

March 3, 2017

All-Payer Claims Databases After Gobeille

APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services, making them a valuable source of information for policymakers and researchers. After the Supreme Court's decision, how will the Department of Labor's response shape their future?

March 3, 2017

The Future Of Precision Medicine: Great Promise, Significant Challenges

Central to the PMI is the All of Us Research Program, which aims to enroll 1 million or more volunteers throughout the United States. If successful, it would be one of the largest longitudinal cohorts ever developed in this country.

February 28, 2017

A New Day For Oversight Of Human Subjects Research

On January 19, the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.”

February 6, 2017

The Best-Laid Plans For Health Care

Tremendous uncertainty awaits, though I expect that we will see a slowing down of the repeal and replace process, with even the individual mandate persisting for some time; unmaking the Affordable Care Act without leaving millions stranded will be harder than the campaign may have suggested.

January 5, 2017

The EEOC’s Role In Reshaping Wellness Programs

A Symposium On Health Law. Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. An EEOC proposed rule has the potential to shape, or reshape, future wellness programs. The extent, however, also remains uncertain.

March 17, 2016

One Patent Law, Two Economic Sectors: Is The One-Size-Fits-All Patent Law Still Workable?

A Symposium On Health Law. Once perceived as fostering innovation, patents have developed a troll problem. Unfortunately, many of the responses taken by Congress and the courts offer a sweeping approach, causing substantial collateral damage to life science patent portfolios.

March 17, 2016

Breaking Good? The Arc Of Antitrust Policy In The Health Sector

A Symposium On Health Law. It appears that 2016 will follow 2015 as another year of massive consolidation in the health care sector. Against this backdrop, it is timely and revealing to examine the current state and trajectory of antitrust law as it intersects and shapes health care policy.

March 15, 2016