The Growing Influence of Patient Advocacy Groups in the Pharmaceutical Industry

In recent years, something big  has changed how patients, pharmaceutical companies, and government agencies like the Food and Drug Administration (FDA) work together. Patient advocacy groups now play a more significant role in deciding which medicines to develop and how to make them available to the public.

What are Patient Advocacy Groups?
Patient advocacy groups are not competitors to the pharmaceutical industry but rather partners that work to help patients.  Consider them like bridges between patients and pharmaceutical companies. The main goals of these organizations are to raise awareness about diseases, educate people about treatment options, and advocate for better care. Patient advocacy groups also advocate for quicker access to new treatments through FDA mechanisms like Breakthrough Therapy Designations, which speed up the drug review process and provide patients with faster access to new products.

Historically, pharmaceutical companies didn't work closely with advocacy groups, but now, most have special departments solely committed to fostering relations with advocates.  Pharmaceutical companies work with advocacy groups to support the group's efforts, ensure patients' needs are addressed, and, of course, help with clinical trial enrollment and drug promotion.  Some of their other activities include inviting patients to speak at company meetings to talk about the impact of their disease and how they cope, participating and supporting races such as 5Ks, and providing funding for the advocacy groups initiatives.

How Patient Advocacy Groups Influence Medicine

There is no doubt that patient advocacy groups have an essential and positive role to play in shaping medicine. Patients in these groups share their experiences and insights about how diseases affect their daily lives, which helps pharmaceutical companies determine what patients need. Patients can then benefit from the development of medicines that address their challenges, giving them hope that better treatments are on the way. For example, the nonprofit organization CancerCare has worked closely with pharmaceutical companies to emphasize the need for supportive care and survivorship programs in cancer treatment. As a result of their more than 25 years of advocacy, new medicines have been developed that take patients' quality of life into account.

Patient advocacy groups also push for the patient's voice to be included in clinical trials. Traditionally, the criteria for participating in trials were often strict, which could exclude people who could benefit from new treatments. Many patient advocacy groups today work to ensure that trials are designed from the patient and caregiver perspective, which may lead to safer and more effective medicines.

How Patient Advocacy Groups Influence Regulatory Policies

In addition to shaping medicine, patient advocacy groups influence government policies. Based on insights from patients and the pharmaceutical industry, the FDA recently recognized the importance of the patient perspective when making regulatory decisions. To this end, they formed The Patient Engagement Advisory Committee.   The committee was created to get direct input from patients and patient organizations on their needs and experiences. Patient viewpoints can help regulators make better decisions that reflect patients' needs, especially those with rare diseases.

Balancing Interests

While advocacy groups need funds to support their efforts, companies need advocacy groups and their members to help develop and often promote new clinical trials and medications. According to a report by Public Citizen, between 2010 and 2020, pharmaceutical companies and their lobbying groups, such as The Pharmaceutical Manufacturers Association, gave at least $6 billion to over 20,000 patient advocacy groups. Some critics argue that by partnering with pharmaceutical companies, patient advocacy groups may lose focus on patients' best interests due to pharma providing funding, the influence pharmaceutical companies have, and their own financial needs.  Thus, there can be perceived conflicts of interest, especially when advocacy groups receive funding from these companies. Transparency and accountability are, therefore, essential from an ethical perspective.  This will help address potential concerns about conflicts of interest and ensure that patient voices remain at the forefront of advocacy efforts.

Conclusion

Patient advocacy groups are helping to change the healthcare landscape in the U.S.  By advocating for patients, these groups are changing medicine development priorities and regulatory policies, leading to more effective treatments that consider the patient's voice. As the U.S. healthcare system continues to evolve, collaboration between patient advocacy groups and the pharmaceutical industry will likely become even more critical in ensuring that the treatments of tomorrow are truly patient-centered. This influence is significant and will continue to shape the future of healthcare.

Kathryn Munoz, PhD, MPH is a the founder of BioPharma Accelerator Coaching.  She has spent decades in the pharmaceutical industry, working with everything from Fortune 500 companies to start-ups.  She has played significant roles in the launch of over 20 new products and indicaitons.  Now, as a columnist for Louder.News, she brings us PHARMA INK: A LOOK BEHIND THE MEDICINES YOU TAKE.  https://www.linkedin.com/in/kathryn-munoz-631b5978/