Whitepaper
State price transparency reporting checklist for life sciences companies
Feb. 10, 2025 · Authored by Mark Scallon, Morgan DiSanto-Ranney, Kenquavius McCollum
Operational strategies to ensure compliance
The drug pricing landscape is rapidly shifting as both state and federal governments increase regulations around price transparency. As of January 2025, New Jersey has launched a registration portal, and Florida passed its transparency law in May 2023, joining 21 other states. With more states expected to follow and the potential for federal mandates, manufacturers face growing pressure to stay compliant. A proactive approach is essential—not only to avoid fines but also to protect the bottom line and stay competitive in a regulated market.
The future of drug price transparency laws is likely to be shaped by both continued state-level actions and federal developments under the new Trump administration. Although there is bipartisan support for controlling pharmaceutical prices, including through transparency measures, manufacturers should anticipate swift regulatory changes, as demonstrated by past initiatives such as the 2018 American Patients First plan.
While state-level transparency laws are expected to continue growing, the shifting federal landscape—potentially including pricing controls or executive orders—could alter the situation overnight. Manufacturers must remain agile to respond to both the ongoing expansion of state laws and potential federal policy changes.
Key Compliance Challenges and Strategies
Twenty-two states have enacted price transparency laws to address rising drug costs, with many requiring pharmaceutical companies to disclose pricing information. These laws often include penalties for unjustified price hikes, and with continued federal support for pricing controls, manufacturers must prepare for an increasingly complex compliance landscape. As more states introduce their own requirements, manufacturers will need to manage both state and federal reporting obligations. This makes proactive strategies crucial for success.
While state laws vary, most require manufacturers to report on new drug entries, price increases exceeding certain thresholds, recurring pricing updates, advance notice of price hikes, and disclosures to healthcare providers. Providing detailed data, such as wholesale acquisition costs (WAC), dosage forms, and marketing expenses, can be administratively challenging, especially as more states impose unique requirements. The growing complexity of these regulations presents further challenges, including protecting sensitive data and interpreting vague product definitions. Non-compliance can lead to hefty fines and damage a company’s reputation. For smaller manufacturers, the strain of compliance—and the penalties for failure—can be especially tough to handle.
