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Drug Importation Lawsuit Stays Alive, For Now

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more

What Should Pharma Companies Expect From the Biden Administration?

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

CMS Releases Interim Final Rule Establishing Reimbursement for Part B Drugs Based on International Pricing

Most Favored Nations Model will alter how certain Medicare Part B drugs are reimbursed. The Centers for Medicare & Medicaid Services (CMS) released an advance copy of an interim final rule with a comment period announcing...more

Trump Administration Takes Aim at Drug Prices Again

The White House released a new Executive Order on September 13, 2020, related to drug prices titled “Lowering Drug Prices by Putting America First” the September Order), whose stated purpose is to address reimbursement for...more

White House Issues Executive Order Impacting Drug Supply Chain

Members of the industry should be on the lookout for proposed rules related to this Order and take advantage of all public comment periods. The White House issued an executive order “Ensuring Essential Medicines, Medical...more

White House Issues Executive Orders Addressing Drug Pricing

The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more

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