News & Analysis as of

Risk Mitigation Drug Pricing

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

White & Case LLP

Strong Medicine: Using Investment Treaties to Mitigate Foreign Regulatory Risk in the Life Sciences

White & Case LLP on

The COVID-19 pandemic has accelerated the globalization of the life sciences industry, driving cross-border collaborations to develop urgently needed treatments, scale up manufacturing and distribution, and fill raw material...more

Baker Donelson

OIG Work Plan – October 2017 Update

Baker Donelson on

The OIG added five new items to its Work Plan with its October 2017 monthly update. This is a decrease from the nine new items added to the Work Plan with the September 2017 update. (For more information on last month's Work...more

Mintz - Health Care Viewpoints

FDA Commissioner Hints at Drug Pricing-Related Initiatives

During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a “Drug Competition Action Plan” that it will unveil in upcoming weeks and months. This was...more

Dechert LLP

Dechert survey: Developments in securities fraud class actions against U.S. life sciences companies

Dechert LLP on

Life sciences companies continued to be popular targets of securities fraud class action lawsuits filed in 2016, and prudent life sciences companies should take heed of the results of this year’s decisions. In 2016,...more

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