If you haven’t had a chance to watch the on-demand webinar, “Navigating Drug Price Transparency: New Product Launch, Enforcement & Compliance,” but are curious about how DPT laws impact new product launches, we’re going to give you a recap of the highlights.
DPT laws are constantly changing and vary from state to state. While DPT activities may not start as early as state licensing, knowing where you are likely to trigger a DPT law in your timeline is crucial.
Sometimes, the definition of the launch date is straightforward for certain companies and specific products. For others, it can be complex, like cell & gene therapies, where a few dates could be potential contenders for defining the product launch.
What goes into a DPT report?
As you prepare to file your DPT-required reports, which we recommend starting at least 4-6 months before launch, these are some essential pieces of information you’ll want to have on hand.
- Manufacturer & Product Master: Gather basic information like manufacturer name, labeler code, and drug name.
- Other information: Collect data on manufacturing costs, research and development expenses, distribution costs, and pricing factors. You must ensure alignment among cross-functional teams.
- State-Specific: Some states may have unique requirements, such as registration IDs or state-specific analyses.
- Additional Analysis: Include detailed information about your marketing plan, pricing factors, and trade secrets (remember that some fields may be omitted due to state requirements).
What does enforcement look like?
States may take different approaches to enforcement:
- Initial Outreach and Education: States may educate non-compliant manufacturers about reporting requirements.
- Requests for Additional Information: Some states review reports and request additional details to ensure compliance.
- Name and Shame: States may publicly identify non-compliant manufacturers.
- Financial Penalties: Fines can range from daily penalties for non-reporting to substantial fines for non-compliance in good faith.
What should you expect after initial reporting
Even after successfully launching your product and meeting initial reporting requirements, ongoing compliance is essential. Key considerations include:
- Ongoing Reporting: Some states require quarterly or annual reports.
- State Action/Lists: Be aware of states that perform their analyses and may require additional information.
- Price Increase Reporting: Some states have complex regulations surrounding price increases, including prohibitions and potential fines.
Navigating drug price transparency is complex, especially during a new product launch. Compliance with reporting requirements, diligent monitoring of state actions, and proactive measures to address potential triggers are crucial for manufacturers. Staying informed, planning ahead, and maintaining a solid compliance framework are essential elements for success in this ever-evolving landscape of transparency and regulation in the pharma industry.