State Price Transparency Reporting (SPTR) has never carried higher stakes for pharmaceutical manufacturers — and the consequences of falling behind are escalating rapidly.
SPTR requirements are not uniform across states, but in recent years, states have increased their legislative and enforcement efforts. Currently, more than 20 states have SPTR requirements, and several other states have SPTR legislation pending. Manufacturers must understand the evolving patchwork of SPTR requirements to ensure they meet each state’s reporting deadlines and requirements across their product portfolios—branded, generic, biosimilar, old, and new. Missing even a single report or deadline can have costly consequences.
Consequences of noncompliance.
The consequences of missing a report or deadline vary by state and can range from a warning letter[1] to fines as high as $30,000/day.[2] Drug price increases, new drug launches, and seemingly minor changes—such as product extensions or new packaging sizes—can trigger reporting obligations.[3] Regardless of whether a manufacturer has only one product or dozens, monitoring state requirements, tracking deadlines, and generating reports has become a complex, time-consuming, cross‑functional challenge.
Compliance doesn’t happen in a vacuum.
The early, aggressive reporting deadlines and in-depth reporting requirements require coordination across multiple departments to ensure compliance and internal alignment.
For example, manufacturers may need to file notices and/or reports:
- as early as 8+ months before a new drug is launched;[4]
- 60 days before a price increase takes effect;[5]
- 3 days after a drug becomes available for purchase in a particular state;[6] and/or
- on a quarterly basis.[7]
Although some reports require only a list of products and their wholesale acquisition costs, other reports require highly-sensitive information such as:
- manufacturing, marketing, and R&D costs;[8]
- financial assistance provided through assistance programs, rebates, and coupons;[9]
- state-specific projected product revenue;[10]
- state-specific patient population estimates;[11]
- product acquisition date and cost, if the product was not developed by the manufacturer;[12]
- and more.
Members of a manufacturer’s pricing, legal, compliance, finance, medical affairs, and executive leadership teams need to closely collaborate to collect, collate, and review the various information needed to determine applicable deadlines and submit required reports. When these stakeholders operate in silos or rely on manual reporting, the risk of missed deadlines, inaccurate reporting, unapproved messaging, and costly oversight rises dramatically.
Manufacturers must be empowered with the right processes, visibility, and tools to submit timely and accurate reports.
How manufacturers can stay ahead
- Audit your current reporting framework to identify gaps and upcoming state deadlines.
- Establish a cross‑functional committee that meets regularly to review price changes, drug changes, new drug launches, and SPTR filings.
- Automate reporting workflows to minimize manual entry, reduce human error, and increase efficiency.
- Centralize data sources and documentation to keep submissions consistent across states.
- Monitor evolving regulations proactively, rather than reacting after deadlines pass.
The Medispend advantage
Medispend’s Price Transparency Reporting Solution and Managed Services simplify and streamline compliance, giving manufacturers a comprehensive view of their obligations across all states. Our technology automates key workflows, updates when regulations change, and helps manufacturers ensure their submissions are timely and accurate, helping them avoid enforcement actions and costly penalties.
As more states expand their reporting requirements, staying compliant will only become more complex. Now is the time to rethink your price transparency strategy and invest in solutions that scale with your business—before risks turn into realities.
Learn more about our Price Transparency Reporting capabilities.
[1] Report by Texas Health Services, Compliance Section of Consumer Safety Branch (11 Notice of Violation letters were issued in fiscal year 2025)
[2] Maine’s Act to Increase Prescription Drug Transparency (22 MRSA § 8735.2) (violators commit “a civil violation for which a fine of $30,000 may be adjudged for each day of the violation”)
[3] New Jersey’s Prescription Drug Price Reporting Regulation (NJAC 13:45K) (A “new drug,” for which reporting is required, is defined to include each product approved under an NDA, aNDA, sNDA, BLA, or aBLA)
[4] Connecticut’s Statute (CGS § 19a-754b(b)) (deadline is 60 days from when a manufacturer receives an NDA or BLA action date from the FDA). The “action date” is commonly known as the PDUFA date, which is typically provided by the FDA approximately 10 months before the NDA or BLA will be fully reviewed by the FDA. PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027 (FDA’s goal is to review 90% of NDAs and BLAs within 10 months)
[5] New York’s Insurance Law Section111-A (notice of price increase shall be provided in writing “at least sixty days prior to the planned effective date of the increase”)
[6] North Carolina’s SCRIPT Act (“A manufacturer shall notify all interested parties of the price of any new prescription drug within three days after it is made available for purchase in this State.”)
[7] Louisiana’s Statute (RS 40:2255.11) (manufacturer must report drug prices “no later than January first, April first, July first, and October first of each calendar year”)
[8] Washington’s Revised Code of Washington (RCW 43.71C.050(1)(d)) (manufacturer’s report must include “itemized cost for production and sales, including the annual manufacturing costs, annual marketing and advertising costs, total research and development costs, total costs of clinical trials and regulation, and total cost for acquisition of the drug”)
[9] Washington’s Revised Code of Washington (RCW 43.71C.050(1)(e)) (manufacturer’s report must include “total financial assistance given by the manufacturer through assistance programs, rebates, and coupons”)
[10] New Jersey’s Statute (N.J.S.A. 45:14-82.3.c(4)) (manufacturer’s report must include the current calendar year’s projected revenue from the sale of the drug in the State)
[11] New Jersey’s Statute (N.J.S.A. 45:14-82.3.d(2)) (manufacturer’s report must include the current calendar year’s projected patient volume for the drug in the State)
[12] North Carolina’s SCRIPT Act (“manufacturer shall disclose to interested parties the date and price of acquisition of the drug if it was not developed by the manufacturer.”
Katherine Johnson
Senior Director – iContracts Revenue Management Suite - Government