Identify REMS Risk Before It Impacts Your Launch.
Failure to evaluate REMS risk early can create avoidable launch risks, including compressed implementation timelines, increased costs, and delayed market entry.
Maintain your organization’s payment transparency compliance with turnkey, white-glove support from Two Labs
With the enactment of the US Physician Payments Sunshine Act in 2013, drug and medical device manufacturers are required to annually report payments and transfers of value to, or on behalf of, healthcare professionals (HCPs, such as physicians, physician assistants, and nurse practitioners) and healthcare organizations (HCOs, such as teaching hospitals) to the Centers for Medicare and Medicaid Services (CMS), which in turn makes the information publicly available.
In addition to federal reporting, many states impose independent transfer of value, gift ban, and sample reporting, and sales representative registration requirements. The consequences of incomplete or inaccurate reporting can be significant, potentially resulting in millions of dollars in fines. As such, manufacturers must maintain careful compliance on an ongoing basis, and they should begin at least six to nine months prior to launch.
As the HCP/HCO spend transparency landscape grows in scale and complexity, our team’s decades of experience in the Sunshine Transparency and Aggregate Spend space supports manufacturers with:
Sunshine Act Reporting
Federal Open Payments reporting including data aggregation, validation, submission readiness, and dispute support.
State Transparency & Aggregate Spend Reporting
End-to-end management of state and local reporting requirements.
Federal & State Sample Reporting
Support for FDA §6004 and applicable state sample reporting.
Sales Representative Registration & Reporting
Management of licensing, registration, and reporting requirements.
Compliance Monitoring
Monitoring of gift bans and internal spend thresholds with proactive risk identification.
Policy Development & Internal Spend Frameworks
Development of Compliance policies and governance frameworks.
Data Validation, Remediation & Dispute Support
Data quality review, issue resolution, and audit-ready reporting.
Our hands-on, white-glove approach to transfer of value reporting is designed to take as much work off your team’s plate as possible while giving you the peace of mind needed to focus on managing and commercializing your product.
We’ve supported 75% of products in the emerging biopharma market
From Drug Price Transparency to State Licensing, our Compliance solutions help drive critical initiatives to position biopharma products for market success
280+ Launches new products and transitions
90% of clients recommend us
150+ experienced consultants on the Two Labs team
Our team is comprised of industry professionals who are experts in their fields. Their expertise extends across a multitude of disciplines in the pharmaceutical industry, from licensing, compendia, and patient services, to channel strategy, finance, and more. We strive not only to be subject matter experts within discipline but also in therapeutic classes.
Our reputation in the industry is that we truly understand our clients’ needs, provide a customized approach, and deliver the results they expect. According to Loyalty Research Center, Two Labs client loyalty was the highest they have seen among any of their B2B and B2C clients.
Source: Loyalty Research Center, August 2018, N=56
No matter where you are in the process, we’re here to support, advise, and implement key strategies to ensure the success of your product.
Failure to evaluate REMS risk early can create avoidable launch risks, including compressed implementation timelines, increased costs, and delayed market entry.
Louisiana’s recent enactment of Senate Bill 401 is another step forward in the evolution of state-level oversight of prescription drug pricing. Effective January 1, 2027, this legislation establishes a Prescription Drug Affordability Board (PDAB) within the Louisiana Department of Insurance and introduces an enhanced and new framework for manufacturer reporting on prescription drug pricing. While the legislation outlines several reporting requirements, many of the operational details surrounding implementation have yet to be defined.
Want to learn more about what Two Labs’ Compliance solutions can do for you? Here are just a few examples of how we make a difference for our clients.
Through every step of the commercial journey, Two Labs is your partner in driving success.
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