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Drug Pricing: What Happened in 2019 and What to Watch in 2020

Have you heard that drug prices are too high? If not, you have not been listening to President Donald Trump, Secretary of Health and Human Services (“HHS”) Alex Azar, or almost any member of Congress. In the past year, a dizzying array of drug pricing actions and proposals have come out of the White House and Congress, as well as the governor’s offices and legislative halls in most states.

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Science and Security Concerns Continuing to Grow

Practices: Health Care

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Last Friday, the National Institutes of Health (NIH) delivered an update on its efforts to identify and manage risks from “foreign influence” in research. In a presentation to an Advisory Committee of senior academic leaders, the update painted a stark picture of growing concern. NIH indicated that in 75% of the cases it has intensely examined, it has found “real problems” and “substantial” issues related to disclosure failures and misuse of federal funds. These issues include failure to disclose conflicts of interest and commitment, as well as double-dipping. Moreover, NIH described patterns of deception that have kept awardee institutions in the dark about individual activities and risks within their communities.

For universities, academic medical centers, and others receiving federal funding for research, this means that scrutiny will continue and perhaps intensify. For industry and the research and development community more broadly, NIH’s update represents one of several markers laid down in the last few weeks to raise awareness around an issue that presents complex challenges to international collaboration and engagement. Among the biggest challenges is ensuring that the spirit of openness, collaboration and academic freedom that characterizes U.S. progress in science, especially basic science, is not compromised as oversight increases.

The National Science Foundation (NSF) released a widely anticipated report from a group of independent, scientific experts, called the JASON group, last week, which found that “actions of the Chinese government” have raised “problems with respect to research transparency, lack of reciprocity in collaborations and consortia, and reporting of commitments and potential conflicts of interest.” Coming at the issue from a different angle several weeks ago, the Senate Committee on Homeland Security released a comprehensive staff report and convened a bipartisan hearing about sustained efforts from the government of the People’s Republic of China (PRC) to exploit and leverage U.S. research progress through “Talents” programs that recruit U.S. investigators. Talents program activities often occur in secret, without disclosure to U.S. university employers or funders, and often with specific conditions that the U.S. faculty and researchers involved not disclose these PRC-related activities to their U.S. employers. Both the JASON and Senate groups reached similar conclusions about threats to progress in the basic and biomedical research enterprise.

In its presentation last Friday, NIH gave special thanks to the institutions and awardees who have expanded their focus on these issues and begun to self-report problematic activities. As the landscape continues to change in this sphere, internal compliance review may become especially critical.

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