The Department of Justice (DOJ) has strongly criticized the Chamber of Commerce’s request for an injunction to block the Medicare drug price negotiation program. In court filings, the DOJ argued that the Chamber had no standing to file the lawsuit and that pausing the program would harm the public. The federal government is expected to announce the first 10 drugs chosen for price negotiation soon.
The Chamber filed a motion in July for a preliminary injunction, claiming that the program would cause irreparable harm to businesses and patients. The DOJ countered by stating that the impact of negotiated prices would not be felt until 2026 at the earliest, and suggested that the case could be fully litigated by that time. The DOJ also argued that pausing the program would harm the public’s interests, as it aims to control Medicare spending and make drugs more affordable for seniors.
The Centers for Medicare and Medicaid Services will soon announce the first 10 drugs eligible for negotiation. Manufacturers of these drugs will have one month to sign agreements to participate in the negotiations. Plaintiffs suing the federal government have argued that the penalties for not negotiating are too severe, including excise taxes. The DOJ, however, argued that the negotiation timeline provides companies with sufficient flexibility. Companies who choose not to negotiate can withdraw from Medicare and Medicaid or divest their interests in the selected drug.
The Chamber of Commerce, along with other organizations such as PhRMA, Merck & Co., and Bristol Myers Squibb, is suing the Department of Health and Human Services over the negotiation program. The DOJ asserted that these suits should proceed independently and without interference from the current case, suggesting that they are an attempt to achieve what lobbying could not.
The DOJ raised questions about the Chamber’s standing to sue, pointing out that the organization is not a pharmaceutical company or trade group directly representing the industry. However, the Chamber claims to be suing on behalf of its drugmaker members and has cited precedent for such a lawsuit. The federal government argued that the Chamber failed to demonstrate “Article III standing,” which requires proof of genuine harm suffered due to the opposing party’s actions.
The DOJ emphasized the voluntary nature of the negotiation program in its motion, stating that companies are not compelled to participate, even if it means losing out on lucrative Medicare income. The government argued that this risk alone does not constitute compulsion.
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