Can pharma make drugs more accessible while still complying with regs?

By Drew Wilkins, managing director, Deloitte Consulting, LLP, and Clarissa Crain, managing director, Deloitte & Touche LLP

 Improving access to therapeutics is a topic that comes up regularly in conversations with our life sciences clients. Some drug manufacturers are looking for ways to make their products more accessible, but their strategies could run into legal and regulatory challenges. In some cases, a program aimed at making a drug more affordable or accessible to disproportionally underserved patients could be perceived as a conflict of interest, or an inducement effort to increase sales—even when the program has been designed with the best of intentions. 

Consider this hypothetical scenario: A 60-year-old woman who lives in a rural area is diagnosed with thyroid cancer. A groundbreaking drug could be effective at managing her condition. However, the drug must be administered in a clinical setting, and she does not have reliable transportation. The pharmaceutical company has come up with a charitable transportation option for such situations. This solution could help make the new therapy accessible to this patient and others like her. However, the company’s Compliance team is concerned the transportation strategy could trigger compliance risks because it could be seen as an inducement to the patient to use a specific product. 

Health outcomes could be negatively impacted by well-meaning regulations and policies that can limit a company’s ability to address the unique needs of certain individuals. Some regulatory frameworks might be incongruent with the changing societal expectations of pharmaceutical companies and the role they should play in ensuring products are affordable and accessible.¹ The False Claims Act—along with various anti-bribery and anti-kickback regulations—was created to protect consumers.² But those rules could inadvertently make it more difficult for some people to access the medications they need.

Pharmaceutical manufacturers typically have differing levels of risk tolerance when it comes to supporting access; this includes efforts that go beyond cost support (e.g., coupons, free or discounted drugs). While some companies have been innovative in their efforts, others have taken a more conservative approach, which is often guided by their Compliance, Legal, and Regulatory teams. But being too conservative could make it difficult for some people to access important prescription drugs.

Regulators have helped remove some challenges

Challenges are varied when it comes to the accessibility and affordability of certain drugs and therapies. Some consumers might not have access to reliable transportation. Others might not be able leave work to visit a doctor’s office, or they might lack childcare during regular office hours. Some people might not be able to afford a life-saving therapy, or their insurance might not cover the cost of diagnosing a disease or providing on-going monitoring. In some cases, pharmaceutical manufacturers have provided regulators with information that resulted in opinions allowing financial or other support to people who needed access to a drug or therapy.

Case in point: In 2023, the Office of Inspector General (OIG) determined that a biopharmaceutical company could provide financial assistance for transportation, lodging, and meals to “financially needy” pediatric patients and their caregiver(s) in connection with a potentially curative therapy for a rare immunodeficiency disorder.² The therapy can require prolonged hospitalizations, frequent outpatient visits, and ongoing diagnostic testing and monitoring. The OIG has issued several similar Advisory Opinions—both in support of and objection to manufacturer proposals intended to make products more accessible to certain people.⁴ These Advisory Opinions tend to be narrow and typically have not resolved the breadth of challenges that exist.⁴ Beyond the regulatory frameworks, pharmaceutical manufacturers also need to consider how changes in payer models can create new hurdles.

Collaboration could help close the gap on disparities

How can pharmaceutical manufacturers comply with regulations while ensuring their products are affordable and accessible to the populations that can benefit from them? One strategy might be to work with internal Compliance, Legal, and Regulatory teams more collaboratively. For some companies, this could be a foundational mindset shift—both in terms of the working relationship and in how each of those teams views their role. This strategy is more likely to succeed if each stakeholder has a role to play in its development.

Industry and brand stakeholders should consider: 

• Early engagement: Initiate early dialogue with Compliance, Legal, and Regulatory teams once the need for an innovative access strategy is identified. Company executives should outline the challenge(s) to the members of each team and explain how the initiatives are intended to address accessibility or affordability. 

• Rules of engagement: It is important to know how regulatory dynamics could affect novel strategies. Company executives should evaluate their strategies to avoid the perception that they might include commercial objectives. The success of an initiative should be measured by its ability to remove barriers. 

• Active dialogue: Evaluate potential solutions with Compliance, Legal, and Regulatory stakeholders. Treat this evaluation as an active dialogue. Ask questions to understand which aspects of a solution might pose potential risk. Can that aspect be changed? What design controls might help ensure that a program is not viewed as inappropriate by regulators? 

Compliance, Legal, and Regulatory stakeholders should: 

• Try to understand the intent: Company executives should be able to outline the unique challenge and their strategies for addressing it. Explore the full continuum of risk and discuss how some elements of a strategy might be more feasible than others. A risk-based analysis of the proposed strategy should be conducted.

• Invest in the partnership: Be willing to partner with internal teams to better understand any underlying issues. Work with those teams to develop innovative ideas that meet customer needs but stay within compliance boundaries. Take time to help educate the teams about compliance and regulatory policies and their potential impact on a product, disease state, and customers.

• Maintain an open dialogue: Be clear about the company’s position as it pertains to open dialogue. Work with regulators to shape policy and/or seek advice (e.g., Advisory Opinions). An open dialog with regulators could make it easier to win approval for a strategy.

Conclusion

Let’s go back to our hypothetical example of the woman who needed access to a therapy to treat her thyroid cancer. The pharmaceutical company’s executives worked closely with its Compliance, Legal, and Regulatory teams to come up with a solution to provide the woman with monthly transportation to a medical office where the therapy could be administered. The proposal led to a favorable OIG opinion.

Pharmaceutical companies are involved with treating illnesses and saving lives. More accessible pharmaceutical products can result in improved societal productivity, better health, and longer lives. 

Successful navigation of solutions often requires a collaborative approach that leverages the abilities of stakeholders focused on reducing disparities and Compliance, Legal, and Regulatory departments. By fostering a culture of partnership and mutual understanding, these stakeholders can transform ideas into implementable and compliant programs.

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Endnotes:

^{1_{The top 10 big pharmas for diversity, equity and inclusion, Fierce Pharma, August 1, 2022}}

^{2_{US settles False Claims Act allegations against pharmaceutical distributor, US Department of Justice, December 13, 2024}}

^{3_{Advisory Opinion, HHS Office of Inspector General, February 23, 2023}}

^{4_{HHS-OIG highlights anti-fraud safeguards for patient assistance programs, Barnes & Thornburg LLP, April 19, 2024}}

^{5_{Advisory Opinion on patient assistance funds, The National Law Review, May 8, 2024}}

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