GSK accused of exploiting loopholes to maintain asthma drug monopoly

A recent report from U.S. Senator Maggie Hassan’s office has sharply criticized GSK’s management of its Flovent asthma inhaler. The report alleges that the British drugmaker employed complex business strategies to preserve its market dominance and evade financial obligations to public health programs.

Avoidance of rebates and impact on patients According to the report, GSK discontinued the branded version of Flovent in the U.S. market at the start of 2024. This move is viewed as a tactic to avoid paying an estimated $385 million in Medicaid rebates required by the American Rescue Plan Act (ARPA). This law mandates that pharmaceutical companies pay rebates if their drug price increases exceed the rate of inflation.

Although GSK partnered with a third party to launch an “authorized generic” at a lower list price, the actual cost for patients and insurers reportedly surged. This paradox occurred because the new version lacked the rebates and discounts previously associated with the branded product, significantly hindering patient access to essential treatment.

Stakeholder reactions

  • Legislative Perspective: Senator Hassan accused GSK of “gaming the system” at the expense of millions of families and children. She urged Congress to close the legal loopholes exploited by pharmaceutical companies to prevent future harm.

  • GSK’s Response: The company maintained that it took proactive steps to notify regulators and partners about the transition as early as 2023. GSK argued that “external factors” and the negotiation processes of intermediaries influenced patient access, while emphasizing its support for patient assistance programs for those in need.

This controversy unfolds just as the market sees the approval of the first “true generic” version of Flovent by Glenmark, which is expected to challenge the monopoly and potentially lower costs for millions of asthma patients.

Source: https://www.fiercepharma.com/pharma/gsks-management-flovent-allowed-it-game-system-sen-hassan

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