Pharmaceutical Research and Manufacturers of America says CMS' guidance for Medicare drug price negotiation disadvantages manufacturers and will hurt innovation.
The trade association submitted a 76-page comment letter to the agency April 14.
In its comments, the association said CMS' proposed process is not a true negotiation.
"Unlike negotiations manufacturers enter into with health plans, the secretary will set prices for selected drugs and enforce them with the threat of legal penalties so severe that no manufacturer could afford to incur them," the association wrote in its comments.
CMS issued its initial guidance for the negotiation process March 15.
The agency plans to publish a list of the first 10 Part D drugs chosen for negotiation in September. These drugs will be the single-source drugs with the highest Part D expenditures over a 12-month period, according to the agency's guidance. CMS will select for negotiation 15 more Part D drugs for 2027, 15 more Part B or Part D drugs for 2028, and 20 more Part B or Part D drugs for each year after that.
Setting prices for medicines will deter manufacturers from investing significant research and development costs into new drugs, the association wrote in its comments.
In an April 14 blog post, PhRMA called the 30-day comment period CMS allowed on its guidance inadequate for an unprecedented change to the Medicare program.
The association also called the proposed negotiation process a "black box," and that the agency does not provide enough opportunities for drug manufacturers and external stakeholders to engage in the negotiation process.
CMS plans to release update guidance based on feedback in summer 2023.
Read PhRMA's full comments here.