On September 9, 2021, the Department of Health and Human Services ("HHS") released its widely anticipated "Comprehensive Plan for Addressing High Drug Prices." The HHS report supports far-reaching legislative and administrative actions. These include changes that would allow the government to negotiate drug prices, limit price increases to the rate of inflation, prohibit "pay-for-delay" agreements, expedite generic and biosimilar drug approvals, restructure cost sharing and reimbursements in Medicare, and tether Medicare payments to patient outcomes. HHS's proposed initiatives would have substantial impacts not only on drug prices, but also on innovation and antitrust policy relevant to the pharmaceutical industry. The HHS report comes in response to President Biden's July 9, 2021
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