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Merck’s IRA Suit Says Congress Had Other Options To Lower Rx Prices

Merck’s high-profile suit Tuesday alleging HHS’ Medicare drug price negotiation policies are coercive and violate drug makers’ First and Fifth Amendment rights says Congress should have instead empowered HHS to either set a maximum amount the government would pay for covered drugs or to use its natural leverage to obtain more favorable drug prices.

Post-Pandemic News

E&C Republicans Demand Targeted Audit Of Medicaid Disenrollments

HHS Office of Inspector General should target its audits of Medicaid redeterminations, which were on pause during the pandemic, to states that CMS considers high risk for improper Medicaid payments due to eligibility errors, House Energy & Commerce Committee Republicans said in a letter to the government watchdog on Monday (June 5).

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Overwhelming majorities of nursing homes are struggling to recruit and retain providers, which has driven huge swathes of the sector to turn away patients, according to a new survey from the American Health Care Association.

FDA has released a new draft guidance for good clinical practice (GCP) when conducting clinical trials, which aims to harmonize the work of an international regulatory group with the agency’s recent work on incorporating new approaches such as decentralized clinical trials, use of wearable devices and artificial intelligence.

Examining conflict of interest rules for advisory committee involvement should be a priority for FDA as the agency looks at revamping its process for gathering outside expertise, two agency center heads said Tuesday (June 6).