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DTC Ad Proposal: Biopharma, Advertisers Marshall Legal Arguments In Opposition

 
• By Cathy Kelly

Industry comments urge CMS to withdraw proposed rule mandating list price disclosures in TV ads, citing legal conflicts.

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The US Centers for Medicare and Medicaid Services lacks the statutory authority to require manufacturers to disclose prescription drug prices in direct-to-consumer TV ads and is precluded from doing so by the First Amendment, manufacturers, free speech advocates and advertisers argue in recent comments to CMS.

The comments respond to a proposed rule on the price disclosure requirement released by CMS in mid-October. They detail anticipated legal and other arguments against the proposal

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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?

 
• By Cathy Kelly

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.

Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 
• By Francesca Bruce

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 
• 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

 
• By Francesca Bruce

Cooperation between health technology assessment bodies across the EU will lead to a better joint clinical assessment process over time, but patients cannot afford a lengthy wait for improvements, speakers at a cell & gene therapy conference said.

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.