Tag Archives: 21st Century Cures Act

Questions About The FDA’s New Framework For Digital Health

Under a new administration, the FDA is experimenting with a new way to balance innovation and risk with emerging medical technologies.

August 16, 2017

How Could The 21st Century Cures Act And The Joint Commission Improve Eating Disorder Care?

With the potential for increased coverage of eating disorder treatment through parity clarification and appropriate federal regulations, there will be a burgeoning interest in quality performance from regulators, payers, and the public.

June 28, 2017

Scott Gottlieb And The Goldilocks Theory Of Bringing Change To The FDA

With the nomination of Dr. Scott Gottlieb to head the FDA headed to the Senate floor, we can expect another Goldilocks debate about whether today’s FDA is too lenient, too tough, or just right in reviewing new prescription drugs.

May 1, 2017

Marketplace Enrollment Down From Last Year Following Post-Trump Inauguration Drop-Off (Updated)

A total of 12.2 million people selected or were automatically enrolled in marketplace plans during the 2017 ACA open enrollment period, reflecting a late-January enrollment slowdown. And the IRS temporarily waived employer penalties connected with a notice about a new health care financing vehicle.

March 16, 2017

To Battle The Opioid Overdose Epidemic, Deploy The ‘Cascade of Care’ Model

Revisiting how the public health community established the systems needed to US AIDS mortality rate in half can serve as a useful guide for states and policymakers to set up the most effective response to the current crisis.

March 13, 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

21st Century Cures Act Lowers Confidence In FDA-Approved Drugs And Devices

While it is difficult to ignore the positive aspects of the 21st Century Cures Act, there is also legitimate cause for concern that the traditional regulatory standards we have come to rely on may be modified, with unknown long-term effects on the safety and efficacy of new drugs and devices.

February 14, 2017

Cures Act, FDA Draft Guidance Suggest Flexibility On Communication Of Real-World Drug Impacts, Though Questions Remain

A key question pertains to the “real-world” impacts of prescription drugs, such as their potential to improve adherence, prevent hospitalizations, and reduce health costs.

February 2, 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 Current 21st Century Cures Legislation Is Still A Bad Deal For Patients

We believe the bill’s potential benefits and modestly enhanced funding for scientific advancement are far outweighed by the increased risk of patient harm, and added pressure on the FDA to rush new products to market without adequate evidence.

November 30, 2016