Bill > S895

This bill introduces comprehensive measures to promote transparency and prevent price gouging in the pharmaceutical drug market. The legislation establishes new definitions for drug categories like "biosimilar" and "brand name drug" and requires pharmaceutical manufacturing companies to provide early notice to a commission about pipeline drugs, generic drugs, and biosimilars, including details about their development, FDA designations, and drug labels. Companies must also notify the commission of planned price increases, specifically for brand-name drugs increasing by more than 15% and generic or biosimilar drugs with significant price increases. The bill creates a framework for reviewing eligible drugs with high costs, allowing the commission to request detailed pricing information from manufacturers and determine a proposed drug value. If a drug's pricing substantially exceeds its proposed value, the commission can require the manufacturer to develop an access and affordability improvement plan that outlines strategies to make the drug more accessible and affordable. The legislation also includes provisions for potential monetary penalties up to $1,000,000 for non-compliance, with collected funds deposited into a Prescription Drug Cost Assistance Trust Fund. Additionally, the bill defines "public health essential drugs" and requires the commission to maintain and publish a list of such drugs, focusing on medicines critical for treating life-threatening or chronic conditions.

Health and Social Services

https://malegislature.gov/Bills/194/S895