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Drug Pricing Policy Show Moves Into Next Act With Biopharmas' Suit Against DTC Ad Rule

 
• By Cathy Kelly

Merck, Lilly, Amgen join advertisers in suit against HHS; rule helped Trump administration spotlight industry pricing practices but potential impact has always been unclear.

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HHS authority to require list prices in direct-to-consumer drug ads challenged in lawsuit. • Source: Shutterstock

Merck & Co. Inc., Eli Lilly & Co., Amgen Inc. and the Association of National Advertisers claim in a lawsuit filed against the US Department of Health and Human Services on 14 June that the department exceeded its statutory authority and violated the First Amendment of the US Constitution with its final rule requiring manufacturers to disclose list prices in direct-to-consumer TV ads for drugs.

The complaint, which was filed in US District Court for the District of Columbia, asks the court to invalidate and order withdrawal of the rule, as well as award the plaintiffs attorney’s fees and court costs. The final rule was issued by the Centers for Medicare and Medicaid Services 8 May and is scheduled to become effective 9 July

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Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
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President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

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• By Francesca Bruce

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

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England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 
• By Eliza Slawther

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

EU HTA Regulation: ‘Stepping Beyond’ JCAs May Be Needed For Very Rare Disease Drugs

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.