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DTC Ad Final Rule Means Reliance On PhRMA Program Risks Enforcement Action – Azar

 
• By Cathy Kelly

Nevertheless, the Pharmaceutical Research and Manufacturers of America announces enhancement of its drug pricing disclosures voluntary program, a Medicines Assistance Tool website that links to individual company sites, in response to the US rule.

Compliance

Pharmaceutical companies risk enforcement action under the Trump Administration’s final rule on list price disclosures in direct-to-consumer TV ads if they think it is enough to observe the Pharmaceutical Research and Manufacturers of America’s voluntary disclosure program, according to HHS Secretary Alex Azar.

The final rule requiring DTC TV ads to disclose list prices was released by the Centers for Medicare and...

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Taiwan To Phase Out Paper Drug Package Inserts By 2027

 
• By Eliza Slawther

Companies that market drugs in Taiwan must submit electronic versions of their package inserts to Taiwan’s drug regulator by the year-end, lawyers say.

Maze Therapeutics’ Claims For Unapproved Kidney Disease Drug Face Regulatory Scrutiny

 
• By Sue Sutter

Vertex challenged Maze’s claims suggesting better potency and efficacy relative to Vertex’s investigational product, but Maze declined to participate in the National Advertising Division’s self-regulatory process.

Lilly’s Direct-To-Consumer Portal Implicated In Texas Anti-Kickback Suit

 
• By Cathy Kelly

Complaint names LillyDirect in action targeting the company’s free nurse and reimbursement support programs for health care providers.

Lawyers Weigh In On ‘Sunshine’ Clause In EU Pharma Reform Package

 
• By Eliza Slawther

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

More from Compliance

Pakistan Adopts Global PIC/S GMP Guidelines In ‘Landmark Regulatory Reform’

 
• By Vibha Sharma

The Drug Regulatory Authority of Pakistan has adopted a new benchmark for good manufacturing practices, ensuring that the quality and safety of medicines produced in Pakistan meet international standards.

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

 
• By Laura Helbling

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.