Generation Patient’s (Health) Policy Lab spearheads our organization's work in health policy, aiming not only to drive significant change in areas that have the most impact on young adult patients but also to empower young adult patients with policy education and advocacy opportunities to ensure that their voices are heard.

Latest Updates!

  • Listen to a brief explanation of patent thickets by one of our 2024 Health Policy Scholars, Adam Koch. Click here to view more educational videos from our scholars!

  • Explore our opinion piece in Stat News discussing the role of social media influencers in prescription drug ads on TikTok and Instagram, their impact on the healthcare decisions of young adult patients, and the FDA and FTC's evolving role.

There is a lot of misinformation about PDABs, and we feel it is essential to address how critical they will be to help our community of young adult patients afford therapeutics! Do you have any other questions? Feel free to email us at admin@generationpatient.org; we will do our best to address them! 

Focus Areas

Our team has collectively identified three policy areas to focus our exploration of multi-faceted solutions. We are proud to be one of the few patient advocacy groups that has declined funding from the private healthcare industry. As a result, each of the priorities below is guided not by financial interests but solely by the unique challenges that we, as young adult patients, face while navigating our transition into adulthood. 

1. Patent Reform

Problem: Over-patenting prescription drugs creates extended monopolies and market control and inhibits timely access to biosimilars and generics. The lack of new and clinically improved biosimilars and generics poses an immense financial burden on young adult patients like us, who are navigating a period of life marked by multiple life transitions and financial instability. 

Solutions: The U.S. Congress has the power to increase the integrity of the patent system through legislative action. Patent reform should include limits on pay-for-delay tactics (companies offering patent settlements to delay competition), patent thickets (generic companies having to navigate a forest of patents often protecting meaningless enhancements), and product hopping (when the manufacturer switches to a follow-on product). Agencies such as the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the United States Patent and Trademark Office (USPTO), and the Federal Trade Commission (FTC) also have the power to curb patent abuse through regulatory action. Furthermore, the White House has the authority to put pressure on both Congress and federal agencies, as it has done through past executive orders. 

Check out our recent work: 

2. Pharmaceutical Direct-to-Consumer Advertising on Social Media 

Problem: The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion has the authority to oversee prescription drug advertisements, including those on social media. Unfortunately, the FDA’s regulations have not caught up with rapidly evolving platforms such as TikTok and Instagram. The FDA has not released guidance since 2014 and has not held a public workshop addressing this issue since 2009. In addition, the rapid rise of influencers advertising prescription drugs highlights the need for more aggressive inter-agency collaboration. Given the power of parasocial relationships that often develop between influencers and their followers and the fact that the majority of social media users on TikTok and Instagram are between the ages of 18 and 34, this is a major concern for young adult patients, who are likely to be most affected.

Solution: The FDA and the Federal Trade Commission (FTC) should develop a task force - as they have done in the past with issues such as biosimilar misinformation and promoting competition - focused on DTC advertising on social media. The FTC has regularly updated its endorsement guidelines, which the FDA could adapt for the applicability of best practices for influencers advertising prescription drugs. 

Check out our recent work: 

3. Clinical Trial Diversity 

Problem: Young adult patients are a growing demographic, with over half of young adults in the United States living with a chronic condition. Yet, clinical care has often treated young adults (>18) similarly to their older counterparts. In addition, young adults are known to be underrepresented in clinical trials. This is significant because there are a great deal of physiological changes that occur between the ages of 18 and 39, which can affect disease processes and presentation, the response to treatments, and potential complications. Young adults may experience different drug dispositions and adverse events for certain diseases, highlighting the urgent need to investigate this population differently than pediatrics or older adults. 

The lack of focus on age extends to adverse event reporting systems. The Food and Drug Administration (FDA) groups ages 18-64 as one demographic in their adverse event reporting, while the Centers for Disease Control (CDC) has narrower subgroups, such as ages18-29, in their adverse event reports. The Surveillance, Epidemiology, and End Results (SEERS) and the National Childhood Cancer Registry (NCCR) subgroups by five years, pointing to the differences in childhood, adolescent, and young adult cancers.  

 
 

Solution: It is critical to disaggregate data for young adults, beginning with sponsors making this data more readily available and the FDA mandating data disaggregated public reporting through its diversity efforts. Furthermore, conditions affecting young adults should be investigated for potentially differing disease epidemiology and trial data should be available for disaggregation by at least five years. 

Check out our recent work: