Monday, March 4, 2024

Assessing the progress of drug price negotiations in court: A review of outcomes to date.

The court cases surrounding the provisions of the Inflation Reduction Act concerning Medicare's ability to negotiate drug prices have seen some recent developments. A suit brought by PhRMA and other associations was dismissed in Texas, where the judge ruled that the district court lacked jurisdiction as the claims fell under the Medicare Act. Despite constitutional questions raised by the plaintiffs, such as violations of separation of powers and due process clauses, the judge determined that the claims did not warrant further review. A case brought by the US Chamber of Commerce was also dismissed last September based on the argument that there was no constitutional obligation for companies to engage in business with the government.

More recently, a Federal judge in Delaware dismissed AstraZeneca's lawsuit, stating that the company did not have standing to bring the suit as they had not shown their property interests were at risk. The judge rejected the notion that not being able to maintain drug prices constituted a violation of due process. The government has been successful in all three cases so far, with dismissals based on lack of jurisdiction, standing, and constitutional need.

Despite the government's favorable outcomes, some cases brought by drug manufacturers are ongoing, but many repeat arguments that have not been successful. While appeals are likely, the chances of reversal seem slim. The impending lawsuits and potential appeals may lead to requests for the Supreme Court to hear the cases. The author believes that Medicare drug price reductions are likely to proceed for the foreseeable future.

The Inflation Reduction Act's drug price negotiation provisions have broader implications beyond Medicare pricing, which will be explored in future articles. Currently, Medicare has already made price offers for the initial list of ten drugs, with respective companies countering these offers. Details of these negotiations are not yet public and may not be disclosed until September.

The author, Derek Lowe, is an expert in pharmaceuticals with a background in organic chemistry. His blog, "In the Pipeline," provides insights into drug discovery and the pharmaceutical industry from an independent standpoint.

In summary, recent court cases have favored the government in upholding the Inflation Reduction Act's drug price negotiation provisions, with several suits by drug manufacturers being dismissed. The future of Medicare drug prices remains uncertain, with potential appeals and Supreme Court involvement looming. The implications of these legal battles extend beyond Medicare pricing and will continue to be monitored.

Source: https://www.science.org/content/blog-post/drug-price-negotiations-court-scorecard-so-far

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