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GSK’s DoJ Settlement Links Executive Bonus To Continued Compliance

 
• By Brenda Sandburg

GlaxoSmithKline pleads guilty to marketing Paxil and Wellbutrin off-label and concealing Avandia safety data from FDA and resolves allegations of kickbacks involving nine drugs; ground-breaking corporate integrity agreement includes novel recoup of bonuses from execs if they or their subordinates engage in “significant misconduct.”

GlaxoSmithKline PLC’s record-breaking $3 billion settlement with the Department of Justice is remarkable in its breadth – including guilty pleas for promoting drugs off-label and hiding safety data from FDA and allegations of kickbacks involving nine products. But it also imposes novel penalties on executives through an accompanying corporate integrity agreement (CIA).

The CIA, which GSK entered into with HHS’ Office of Inspector General, requires the company to recoup annual bonuses and incentives from executives if they or their subordinates engage in “significant misconduct

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HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

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.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

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New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.