Generation Patient Awarded Grant From the Lucile Packard Foundation for Children’s Health

We are thrilled to announce we have been awarded a grant from the Lucile Packard Foundation for Children's Health to support an initiative focused on identifying current systemic challenges and opportunities for young adults living with chronic and rare conditions!

Over the next four months, Generation Patient will convene a series of meetings with both patient and medical advisory boards. These advisory boards will meet up to five times to explore a wide range of systems-level issues impacting young adults (aged 18-30) living with chronic and rare conditions. Through these discussions, the boards will identify 6 to 8 key themes that highlight the most pressing system challenges and opportunities for our young adult patient community. The outcomes of these meetings will shape a series of Roundtable discussions scheduled for next year, where these critical issues will be further explored in depth.

Patient Advisory Board (PAB) Members

• Rose Keller, Bachelor’s in Political Science and Government (LinkedIn)

• Maanya Tarnal, Undergraduate Student in Public Health (LinkedIn)

• Kiran Rachamallu, Bachelor’s in Public Policy and Biology (LinkedIn)

• Grace Shults, Bachelor’s in Psychology (LinkedIn)

• Anna Ball, Master’s of Public Health (LinkedIn)

• Rachel Litchman, Bachelor’s in Sociology and Gender/Women’s Studies (Bio)

Medical Advisory Board (MAB) Members

• Jennifer Disabato, DNP, CPNP-PC, AC (Bio)

• Rita Nathawad, MD (Bio)

• David Rind, MD, MSc (Bio)

• Susan Shanske, MSW, LICSW (Bio)

• Michelle Wright, LCSW, MSW (Bio)

Generation Patient has hosted a variety of roundtables with different structures and models. Our roundtable initiatives ensure that young adult patients are at the helm of discussions that directly influence research, policy, and systems-level solutions that impact our health and quality of life. For more information on our other roundtable series, please visit https://generationpatient.org/roundtables.

Rachel Litchman Spotlights Medicaid Rollbacks: Why Patient Protections Matter

We are excited to share that one of our 2024 Health Policy Scholars, Rachel Litchman, has published an op-ed in The Progressive. In her piece, "Medicaid Unwinding Unfairly Puts Patients at Risk," Rachel highlights the devastating impact of recent Medicaid rollbacks on vulnerable patients. Her insights emphasize the urgency of protecting access to healthcare, especially for those with chronic conditions. This article is a must-read for anyone passionate about health equity and policy reform.

Read the full article here!

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Guidance for Industry

Generation Patient is a nonprofit organization created by and for young adult patients—i.e., young adults with chronic medical conditions such as lupus, inflammatory bowel disease, Lyme disease, rheumatoid arthritis, and more. As young adults, we are at a pivotal life stage: navigating the transition to adulthood while simultaneously managing unpredictable health conditions and our personal, educational, professional, and psychosocial needs. To address our community's unique challenges, Generation Patient provides peer-support programming and drives systemic change through policy work, leadership programming, and evidence generation.  We aim to amplify young adult patient voices in critical conversations where real change can occur. Through this strategy, we envision a future where young adults with chronic medical conditions can live with greater quality of life, access, dignity, and fulfillment. As an organization, we do not accept funding from private healthcare, including pharmaceutical and insurance industries. We are guided entirely by the lived experiences of young adult patients, including this community-drafted comment. 

Below, we have included some considerations from our community of young adults with chronic/rare conditions, many of whom are heavily impacted by the issue of underrepresentation in clinical trials. 

The Importance of Including Young Adults in Clinical Trials and Disaggregating Reported Data

Young adult patients represent a distinct and growing demographic, with over half of young adults in the United States managing at least one chronic condition. Despite this, clinical care often categorizes young adults (aged 18-34) similarly to older adults, leading to significant public unknowns of young adults in clinical trials. This oversight is concerning because physiological changes unique to this life stage, such as hormonal shifts and metabolic variations, can significantly impact disease presentation, treatment response, and potential complications. For certain conditions, young adults may experience different drug effects or adverse events compared to older populations, highlighting the need to treat this age group as distinct from "pediatrics," “adolescents,” "adults," or "older adults."

Key Considerations for Clinical Trials: 

1. Defining Age Brackets: Clinical trials often group a wide range of ages (e.g., 18-64) when publicly reporting safety and efficacy data. This broad categorization can obscure age-specific responses to treatments. Establishing clearer age brackets in clinical trial design and data reporting is crucial for identifying potential risks or dispositions unique to young adults. 

2. Understanding Biological Impacts of Age on Drug Safety and Efficacy: The biological impact of age on drug response and safety is a crucial but under-researched area. While significant progress has been made in understanding how age affects drug responses in cancer treatments, this knowledge is largely absent for other chronic and rare conditions. Young adults who experience unique physiological changes—including hormonal shifts, rapid metabolic adaptations, and varying immune responses—may react differently to medications compared to older adults. Failing to account for these age-specific biological differences can lead to suboptimal treatment protocols, unrecognized adverse events, and overall poorer health outcomes for our demographic. Exploring how hormonal changes, common during young adulthood, affect drug efficacy and safety is crucial. For example, fluctuations in hormones like estrogen, progesterone, and testosterone can influence how medications are metabolized, potentially altering their therapeutic effects or risk profiles. These considerations are important for recognizing and mitigating potential complications that may arise from inappropriate drug dosing or overlooked side effects.

3. Examples of Age-Related Differences:

• Hormonal Profiles and Fertility: Studies have shown significant variations in hormonal levels across different age groups, affecting fertility-related outcomes. For instance, younger women (<20 years) and those aged 20-29 have more favorable hormonal profiles than women aged 30-39 and 40-49. These differences indicate that fertility-related adverse events may be underreported or misinterpreted if data from younger and older women are combined. (Bartimaeus et al., 2020)

• Impact of Immune Checkpoint Inhibitors (ICIs): Research on the effects of ICIs in young women with melanoma demonstrated a decrease in ovarian reserve markers, highlighting the need to separate younger women in clinical trials to accurately assess the impact of treatments on fertility. (Hickman et al., 2023)

• Ovarian Reserve in Hypopituitarism Patients: A study on women with hypopituitarism found that they had lower AMH levels compared to age-matched controls, illustrating how underlying health conditions can influence fertility outcomes. (Fitz et al., 2023).

Proposed Solutions and Considerations:

• Sponsors should make age-specific data more accessible, and the FDA should mandate public reporting of disaggregated data by age.  

• Research on conditions affecting young adults should prioritize exploring the potential for unique disease epidemiology in certain conditions. Trial data should be disaggregated by at least five-year increments to provide a clearer understanding of age-related differences. 

• Young adult patients are at a unique time period as it pertains to independence. The fear and stigma of sexual and reproductive health is an important consideration in the enrollment of young adults in clinical trials. Ensuring confidentiality and creating a supportive environment can encourage participation from these under-represented groups.

• Trust: Sponsors should be required to provide more clarity surrounding post-trial access to meds. This is a real opportunity to increase trust by understanding the long-term opportunity to access medicines as part of a trial. 

Recommendations for Improving Adverse Event Reporting:

While not specific to clinical trials, the lack of focus on age-specific data extends to adverse event reporting systems. The FDA currently groups individuals aged 18-64 as a single demographic, while the CDC and other registries use narrower age bands. Disaggregating data by narrower age brackets is crucial for capturing the nuances of disease epidemiology and treatment effects in young adults. 

Young adults with chronic and rare conditions must be included in clinical trial design for disease areas impacting our demographic. We are a growing demographic with many specific considerations, as outlined above. We welcome the opportunity to engage further. 

Sincerely, 

Generation Patient

admin@generationpatient.org

Senate Introduces First-of-its-Kind Legislation to Stop Manipulative Prescription Drug Advertising on Social Media

The Protecting Patients from Deceptive Drug Ads Online Act empowers the FDA to update its regulations and enforcement to better protect public health and stop misinformation.

Nearly 90% of teens and young adults who use social media say they use it to find information about their healthcare. However, as pharmaceutical marketers have shifted more and more of their budgets towards selling their products on social media, especially via paid influencers, the FDA’s regulation has lagged behind.

The Protecting Patients from Deceptive Drug Ads Online Act, introduced by Sen. Durbin (D-IL) and Sen. Braun (R-IN), directs the FDA to update and enforce its regulations for how prescription drugs are promoted on social media, focusing the agency’s attention specifically on deceptive or misleading communications by telehealth companies, social media influencers, and healthcare providers. The legislation will tackle misinformation and manipulative advertising tactics by: 

• Enforcing the same accurate information requirement on social media advertising that the FDA has for ads on TV, in newspapers, etc. That means making sure all drug communications on social media must include clear and accurate information about side effects, contraindications, and effectiveness.

• Creating penalties for telehealth companies, social media influencers, and healthcare providers who benefit financially from sharing misleading information about prescription drugs on social media. 

• Directing the FDA to monitor communications that are specific to social media, like microinteractions between paid influencers and followers in comment sections.

• Making the FDA keep a payment disclosure database where payments made to influencers or healthcare providers to promote drugs must be reported and made public.

• Establish a task force in coordination with the Federal Trade Commission to enhance monitoring and enforcement with respect to prescription drug advertisements. 

As an organization focused on advocating for the interests of young people with chronic conditions, Generation Patient is proud to have played a foundational role in bringing this issue to the attention of legislators and supporting its development. 

“This legislation comes not a moment too soon. For years, patients, especially young patients, have been left to fend for themselves as pharmaceutical marketers have gotten away with pushing misleading and unbalanced content on social media. This bill is an exciting first step to that while forcing the industry to be more transparent and publicly accountable. Thanks to Senator Durbin and Braun for listening to patients’ concerns, this bipartisan bill is a must-pass legislation for both parties,” said Sneha Dave, founder of Generation Patient.

The common sense appeal of this legislation is underscored by the diverse coalition of public interest groups endorsing it,  which includes the Young People’s Alliance,  the American Academy of Family Physicians, Public Citizen, Doctors for America, and the Public Interest Research Group.

Want more information on the Protecting Patients from Deceptive Drug Ads Online Act? Join patient advocates and issue experts for a briefing and Q&A on Monday, September 16th at 10:30 am EST! We are thrilled to be co-hosting this briefing with the Young People's Alliance and the U.S. Public Interest Research Group. As young patients and the primary targets of these deceptive ads, we understand firsthand the harmful impacts of misleading and manipulative pharmaceutical advertisements on social media.

Register for this webinar here!!

Generation Patient Comment: Addressing Misinformation About Medical Devices and Prescription Drugs

Generation Patient is a nonprofit organization created by and for young adult patients—i.e., young adults with chronic medical conditions such as lupus, inflammatory bowel disease, Lyme disease, rheumatoid arthritis, and more. As young adults, we are at a pivotal life stage: navigating the transition to adulthood while simultaneously managing unpredictable health conditions and our personal, educational, professional, and psychosocial needs. To address our community's unique challenges, Generation Patient provides peer-support programming and drives systemic change through policy work, leadership programming, and evidence generation.  We aim to amplify young adult patient voices in critical conversations where real change can occur. Through this strategy, we envision a future where young adults with chronic medical conditions can live with greater quality of life, access, dignity, and fulfillment.

As an organization, we do not accept funding from private healthcare, including pharmaceutical and insurance industries. We are guided entirely by the lived experiences of young adult patients, including this community-drafted comment. 

Today’s young adult patients face unprecedented online misinformation, disinformation, and misleading content. While some come from influencers without direct financial ties to the industry, we are particularly concerned about the misleading information driven by industry-supported messaging. To address this, we urge the FDA and industry leaders to collaborate with young adult patients, ensuring that online information is shared with integrity and accuracy.

We are deeply concerned by misinformation from influencers and micro-influencers over the past few years, especially with the popularity of platforms like TikTok. Earlier this year, we published an article in STAT News emphasizing the need for the FDA to collaborate with the FTC. The FTC regularly issues endorsement guidelines, and direct coordination between the two agencies could lead to more relevant and timely updates to combat misinformation and disinformation online.

These updates are long overdue—current guidelines were released over a decade ago when many of us were in middle or high school. Now, as young adults, we are witnessing a dramatic increase in online influence, leaving patients exposed to a constant stream of misleading information. While we appreciate the additional details in the recent guidance, it’s important to note that these guidelines are not legally binding for the industry. We believe there is an urgent need for stronger enforcement of industry accountability, particularly when direct financial ties are involved.

Instances of the FDA’s attempts to combat misinformation have been cited in the guidance, but more needs to be done, particularly in developing and promoting comprehensive resources. For instance, despite being active in combating misinformation, many of us were unaware of tools like the Rumor Control website, and we believe such platforms fail to effectively reach our demographic. We strongly recommend the FDA collaborate with young adult patients to develop more relevant and accessible sources of information. Rather than telling young people what to think, we recommend that the FDA focus on creating resources to educate our generation on how to think about information online. This process creates more trust, especially since, in many cases, misinformation is not straightforward. 

We also recommend Commissioner Califf and other FDA representatives speak to the broader public more frequently. Conferences cited in the guidance, such as FDLI, do not reach communities like ours. Moreover, these conferences are often prohibitively expensive, making them inaccessible to members of the public who may want to attend. More authentic and accessible efforts to reach the public are urgently needed. 

Additionally, our community of young adult patients would appreciate further additions or clarifications on several aspects of the guidance:

• Clarify the meaning of “Independent Third Party”: For example, does "independent third party" include entities with any past or present financial relationship with the manufacturer, even if that relationship is unrelated to the ad or post in question? 

• Directly Address Micro-Interactions: The guidance lacks clarity on how misinformation spread through comment sections, direct messages, or other micro-interactions between influencers and followers should be handled. These exchanges, as identified by our community of young adults with chronic medical conditions, are often the most impactful and misleading. We recommend addressing the speed of dissemination of the advertisements (“virality”). We’ve seen ads with misinformation rack up millions and millions of views thanks to their virality; ignoring that factor is a big missed opportunity.

• Clarify Applicable Organizations and Individuals: The guidance needs to be more specific on the types of organizations and individuals subject to these regulations. Both organizations and paid individuals must be held to the same standards of accountability when sharing false or misleading information. Without clear guidelines, paid promoters may evade the scrutiny that larger organizations face.

• Provide Data on the Benefits of FDA Actions: While the FDA has outlined its actions to combat misinformation, data on the effectiveness of these efforts needs to be included. For example, resources are spent on initiatives like the FDA’s Rumor Control, but we need to know if they are making a measurable impact or if resources could be better allocated.

• How is “Widespread Misinformation” Measured? If a firm has to, at minimum, identify at least one communication, how is the rest of the harmful misinformation dealt with? Which party is responsible for that? “When a firm identifies widespread misinformation, the firm should, at a minimum, clearly identify at least one internet-based, independent third-party communication that contains the misinformation the firm is addressing. For example, a firm might do this by noting the date and specific location within the internet-based setting where the independent third-party communication was posted. A firm can also note that the identified misinformation appears on other social media platforms” (p 14).

• We believe that “applicable FDA labeling/advertising requirements” cover this, but we would want to ensure that if firms enlist the help of an influencer to convey the firm’s message, it is clearly indicated as an advertisement on social media and to disclose by whom they are being paid to say what they are. “That might include, for example, enlisting the help of HCPs through promotional communications directed to that audience; reaching the general public through a TV advertising campaign; enlisting an influencer to convey the firm’s message in internet-based settings; or any combination of these techniques. If the resulting promotional communication is consistent with applicable FDA labeling/advertising requirements, there are no special considerations created by the fact that the promotional communication addresses misinformation” (p 19). 

• We recommend clarity on the following section by answering these questions: “Are influencers or other personalities paid to make statements like that? If so, how is that disclosed? Who creates and publishes “help-seeking” communications?” “Finally, communications, sometimes characterized as help-seeking or institutional, represent another option firms have to address misinformation. These are communications that (1) do not name any specific medical product or make representations or suggestions that are associated with a specific medical product and (2) are separate and distinct from promotional communications about any specific approved/cleared medical product. Such communications are often used to provide information to raise awareness about diseases or general classes of available treatments. This information may be helpful in addressing false, inaccurate, or misleading information on these topics.”

• We commend the wording here, on page 17: “FDA recommends that when firms choose to voluntarily address misinformation, they prioritize (1) misinformation that has current relevance (e.g., misinformation that is trending or actively spreading on internet-based platforms) and (2) misinformation that is being spread by independent third parties that have large follower bases or hold positions of trust because those users may have a wider range or a higher degree of influence. For example, a post by a social media personality with a large follower count will generally reach a broader group of users compared to a user with a small follower count.”

• We are concerned that the guidance excludes television and radio advertisements, even when those ads are distributed online, such as through streaming services. TV ads often feature celebrities promoting medical products, and many of these celebrities also use their social media platforms to push the same products. This creates a crossover between TV and social media that amplifies misinformation, yet TV ads are notably excluded from this guidance. We believe this omission overlooks a critical component of how misinformation spreads, particularly given the role of celebrity endorsements in both mediums.

We would like to reiterate that developing pathways for misinformation education cannot be done without the people most impacted being involved in direct development, especially those voices and experiences independent of private healthcare industry funding. We greatly look forward to supporting the FDA’s efforts through our collective and deeply informed young adult patient community. Thank you for including our perspectives in the finalization of this guidance. 

Sincerely, 

Sneha Dave

Executive Director 

Generation Patient 

Sydney Reed

Director of Operations 

Generation Patient 

Rosa Kelekian, MSW 

Program Manager

Generation Patient 

Casey Doherty 

2024 Health Policy Scholar

Generation Patient 

Peyton Miles 

2024 Health Policy Scholar

Generation Patient 

Correspondences can be directed to admin@generationpatient.org.

A Step Toward Health Equity: Support for Ruling on Terminal Disclaimer Practices

One of Generation Patient's key policy priorities is patent system reform as a crucial step toward achieving health equity. By advocating for changes that ensure timely access to affordable prescription medicines and encourage genuine innovation in drug development, we aim to help close the healthcare access gap. In July, we voiced our support for a proposed rule from the United States Patent and Trademark Office (USPTO), titled "Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting Proposed Rule." This proposed rule would help to prevent the misuse of patent laws that can delay the availability of cheaper, life-saving medications. Keep reading to understand how this rule might impact you as a patient!

What is a terminal disclaimer?

A “terminal disclaimer” aligns the expiration date of multiple related patents. This means that if a pharmaceutical company files multiple patents on a drug at different times (“patent thicketing” or “double patenting,” which is often done to extend the amount of time a drug company is allowed to make/profit from a medication) exclusively, patents that are filed later on would still expire at the same time as the initial patent. This helps ensure that companies can’t keep drawing out their monopoly on a medication, particularly if the newer patents are for minor changes (modifications that are not additionally beneficial to patients, like changes in packaging, inactive ingredients, etc.).

The problem:

Despite terminal disclaimers' intended purpose (preventing extensions of patent monopolies and reducing patent thickets), larger pharmaceutical companies have found ways to weaponize terminal disclaimers. These strategic patenting practices actually can contribute to the formation of patent thickets!

USPTO’s proposed solution:

To help address this misuse of terminal disclaimers, the United States Patent and Trademark Office (USPTO) has proposed linking the enforceability of terminally disclaimed patents with their corresponding 'parent' patents.

Currently, terminally disclaimed patents (a newer and original patent) are linked by expiration date but can still be individually enforced in legal actions, meaning they can be used to block competitors even if they do not represent significant new innovations.

The proposal suggests that the enforceability (the ability to use these patents in legal actions to prevent others from entering the market) of these terminally disclaimed patents should be tied to the enforceability of the parent patent. 

Essentially, if the parent patent is found to be invalid or unenforceable, the terminally disclaimed patents would also lose their enforceability.

As an organization created by and for young adults with chronic conditions, our community faces decades of enormous financial pressure from the high cost of prescription drugs. We expressed our support for the proposed rule, as this step is an opportunity to ensure timely access to biosimilars and generics and to incentivize true innovation.

Read our full letter, with contributions by our Health Policy Scholars, to the United States Patent and Trademark Office here!

Q&A with Program Manager Rosa Kelekian!

A bit about Rosa: Rosa has been working with us to varying degrees since 2019, and we're excited to have her officially join our team full-time as our program manager!! Rosa was first diagnosed with celiac disease at just 18 months old and has since been diagnosed with IBD, Ehlers-Danlos Syndrome, ADHD, and other chronic conditions. Rosa is based in northern California, where they earned their Master of Social Work (MSW) from the University of California, Berkeley. With her extensive experience in patient advocacy and engagement, combined with her lived experiences, Rosa is helping us to expand our programs, reach, and support for young adult patients!!

Favorite hobby/activity outside of advocacy? 
I’m very into plants and animals, so I love gardening, snuggling with my senior dog Osita, and learning silly plant/animal facts. 🌱 I also like games and doing little crafts, when I have the energy! 

What’s your go-to song when you need a mood boost OR do you a favorite song that you could listen to on repeat and it would never get old?
I have too many favorites to choose, but I love any/all songs by Janelle Monae or Lil Nas X (I also have a soft spot for 2010’s pop-punk, like Panic! At the Disco or Fall Out Boy 😂).

How has your experience growing up with multiple chronic conditions shaped your personal and professional goals?
I was diagnosed with my first autoimmune condition when I was a year and a half old, but really began struggling during my early teen years as more health issues popped up and I got sicker and sicker. I missed a LOT of middle and high school, since I was either too sick to leave the house or was in the hospital. I was really afraid to share about my health issues with any of my peers – I didn’t know anyone my age dealing with chronic illness, so I just assumed no one would understand. So I just didn’t talk about it, and tried to hide it so I could pretend I wasn’t struggling.

As a result, I felt extremely isolated as a teenager and young adult. It wasn’t until college (HUGE credit to Audre Lorde’s essays/poems “The Transformation of Silence into Language and Action” and “A Litany for Survival”), when I slowly started to share little pieces about my experiences with chronic illness, that I realized how much connection and community mattered.

Seeking out community - and quickly realizing that SO MANY other patients felt the same way as I did - made me want to do something with my experiences, and try to change things. Getting involved in advocacy work completely changed my life, and taught me that while self-care is important, community care is what truly sustains us. Being able to do work that increases support, care, and community (things that younger Rosa definitely needed!) not only feels in line with my goals, but is also incredibly healing for me!

What has inspired you to work with GP and join the team full-time? 
I think my biggest motivator is the powerful feeling of working alongside other young adults with chronic health conditions/disabilities. Being around people who just get it and share a deep passion for change and advocacy is incredibly energizing for me. I love getting to connect with other YA patients through our peer groups and programs, and feel so lucky to hear so many other patients’ stories and wisdom. 🙂 

Generation Patient Applauds Passage of Affordable Prescriptions for Patients Act to lower prices for patients and promote innovation

On behalf of the young adult patient community we serve, we welcome the passage of the Affordable Prescriptions for Patients Act (S. 150), which addresses patent thickets. 

Patent thickets occur when brand-name pharmaceutical companies accumulate numerous patents, creating a dense "thicket" that makes it difficult for cheaper biosimilars and generics to enter the market. This means patients will go years, even decades, without access to affordable alternatives to the brand-name medications they need. Tackling patent thicket abuse is important not only for timely access to affordable drugs but also for promoting innovation in the pharmaceutical industry.

As young adults diagnosed with chronic conditions, patent reform is especially important to us as we face decades of financial strain due to the significant expenses associated with managing our medical conditions. The high cost of essential medications places an enormous strain on us, and those from lower socioeconomic backgrounds face an even harsher reality, as the cost of managing their conditions often perpetuates a cycle of poverty, making financial independence nearly impossible. This strain not only impacts their immediate quality of life but also their long-term financial stability, hindering their ability to invest in education, housing, and other opportunities.

While we are thrilled for the unanimous passage of this legislation, young adult patients need much greater reform to ensure access to affordable therapeutics now and throughout our lifetime. We look forward to seeing legislation address product hopping, pay-for-delay, enhanced collaboration, and transparency between the USPTO-FDA. We await continued bi-partisan efforts to promote affordability and increase competition. 

We’d also like to note that this bill does not cap the number of patents to 20; rather only caps certain types of patents to 20 related to the following: 

• The biologic product, its method of use, or a method or product used to manufacture the biological product

• That have a filing date of more than 4 years after the first approval of the branded drug

• That include a claim to a manufacturing process that is not being used by the branded drugmaker.

We urge further action from Congress and commend patent reform champions and members of the Senate Judiciary Committee for supporting efforts to ensure the affordability of our drugs. We thank the numerous patient groups, researchers, and representatives for continuing to work toward reforming the patent system.

A Reflection on My White House Visit: The Implications of Biden’s Prescription Drug Law for Women

By Peyton Miles

I find myself reflecting on the women who have shaped me into who I am today. Each woman, whether a mother, sister, or daughter, offers a unique perspective on what it means to be a woman. However, I have found that resilience and strength out of the sheer necessity to ensure the health and well-being of oneself and one’s family, are burdens that every woman must carry. 

The U.S. healthcare system encompasses many barriers for women: from a lack of research into women’s specific health needs, economic disadvantages, gender bias, and cultural and societal bias. President Biden sought to combat some of these issues through his Prescription Drug Law. On Tuesday, April 2, 2024, I had the distinct honor of attending The White House convening on ‘How Women are Benefitting from President Biden’s Historic Prescription Drug Law’ to learn about the multidisciplinary approach that Biden’s policy team has taken to ease the burden that healthcare so greatly affects women across the U.S.  

Before I get into the events of the day, let me introduce myself. My name is Peyton Miles (she/her). I am a Black 20-year-old female, living with New Daily Persistent Headache (NDPH), and co-morbidities. While my various conditions have uprooted my initial life plans, they have provided me with the opportunity to become a health policy scholar at Generation Patient. It was through this program that I found myself at the Eisenhower Executive Office Building in Washington D.C., about to embark on my first in-person event as a member of Generation Patient.   

There was an immediate air of excitement as I entered the room where the convening was to be held. Just to be here, I gained a sense of historical significance. Expansive arches, vaulted ceilings adorned with intricate sconces and hand-carved wood, and four beautiful chairs on the platform at the front of the room momentarily left me breathless. The room was full of about 30-40 people all eager to hear what strides the Biden Administration has taken in improving women’s health in the U.S. 

The session began with Domestic Policy Council Director Neera Tanden, Deputy Secretary of Health and Human Services Andrea Palm, Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure and Deputy Administrator and Director of the Center for Medicare Dr. Meena Seshamani, and Gender Policy Council Deputy Director Katie Keith, providing an overview of the multidisciplinary approach taken to create Biden’s Prescription Drug Law whose goal is to improve the lives of women on Medicaid. In each of their introductions, they highlighted the ways in which the Inflation Reduction Act will reduce barriers to healthcare. 

The Inflation Reduction Act had four key improvements for women: prescription drug cost reduction, caps on out-of-pocket expenses, extended subsidies, and improved access to preventative services. The implementation and impact of these changes were presented in the form of speakers and a panel featuring our very own Sneha Dave - Executive Director of Generation Patient, Stacie Dusetzina - Professor at the Vanderbilt University School of Medicine, Jocelyn Frye - the President of the National Partnership for Women and Families, and Leigh Purvis - the Prescription Drug Policy Principal of the AARP, and last but certainly not least, Samantha Reid - a Patient Advocate and Senior Director of Digital Engagement at the Center for American Progress.    

The implementation of these improvements was described to be in the form of a “phased rollout.” Ten prescription medications are the initial focus of the prescription drug cost reduction, with a focus on medications that specifically impact women and minorities. This includes life-saving medications such as treatments for cancer, autoimmune disorders, asthma, and insulin, which will specifically have a significantly lower cap of $35 per month for those on Medicare. The law also includes capping out-of-pocket costs for Medicare subscribers to $2000 per year by 2025. These changes will help to ease the financial burden that healthcare often brings for women as they look to care for themselves and their families. 

As someone who is constantly dealing with the “other side” of the healthcare system, it was energizing to be in a room full of people who not only acknowledged the barriers and inequities that women face, but also took action to improve access and quality of care. As we look ahead to health policies even beyond the transformative IRA, that impact access to medicines for young adults with chronic conditions, I am looking forward to engaging in our work to reform the patent system to ensure innovation and timely access to biosimilars and generics.  

Strengthening FDA Guidance: Essential Steps to Combat Online Prescription Drug Misinformation

The FDA’s updated guidance on online prescription drug misinformation, titled “Addressing Misinformation About Medical Devices and Prescription Drugs,” is a welcome first step in tackling the dangerous and under-regulated world of direct-to-consumer marketing of pharmaceutical products. However, this guidance alone is not nearly enough to address this serious problem.

To really protect patients from the harm of misinformation, the FDA’s guidance needs to better account for the unique features of social media and the agency needs to prepare actions to actually enforce its guidance. 

Generation Patient recommends five immediate steps the FDA can take to bolster its guidance: 

1. Provide greater clarity on what an "independent third party" is. For example, does "independent third party" include entities with any past or present financial relationship with the manufacturer, even if that relationship is unrelated to the ad or post in question?

2. Directly address micro-interactions between influencers and followers. There is no mention of how to handle misinformation spread through comment sections, direct messages, or other micro-interactions. Generation Patient’s community of young adults with chronic medical conditions has identified these exchanges as the most impactful and potentially misleading.

3. Directly address the advertising strategy of following TikTok trends. We’ve seen ads with misinformation rack up millions and millions of views thanks to their virality; ignoring that factor is a big missed opportunity.

4. Provide greater clarity on what kind of organizations this guidance applies to. The guidance lacks explicit mentions or examples of the kinds of organizations this applies to. Organizations and paid influencers alike should be held to the same accountability standard for sharing false/misleading information.

5. Provide data on the benefits of the FDA’s actions. While FDA has outlined some of its public actions to combat misinformation, we need data on the benefits of the FDA’s actions, especially for websites like FDA’s Rumor Control which require resources to produce. Could these resources be better spent elsewhere?

As the FDA goes further into its new oversight over this space, it is essential that they engage young adult patients and bring them in to co-create material, assess health information, and inform regulation. No one knows the danger of this content better than us.

Check Out Generation Patient's Comments on PTAB Rules

Take a look at our comments to the U.S. Patent & Trademark Office on the Patent Trial and Appeal Board (PTAB) rules! These rules impact the affordability of medications by addressing invalid pharmaceutical patents, which can drive up drug prices for patients like us!

Key Points:

• Empowerment in Healthcare: Our comments emphasize the importance of patient voices in healthcare policy, advocating for regulations that support lower drug prices by challenging invalid patents.

• Support for Proposed Regulations: We support regulations that prioritize the merits of petitions and preserve the ability for any individual to file a review, which can lead to significant reductions in drug costs.

• Impact on Public Health: We feel the proposed changes aim to balance public interest and maintain accessible PTAB proceedings, which we believe to be crucial for innovation and competition in the pharmaceutical industry.

Read more to gain insight into how these changes could enhance healthcare access and quality for young adult patients with chronic conditions!

Reflections from our time at the Disability Inclusion Fund grantee convening!

Earlier this month, our team had an amazing time attending Building Power Together, the first-ever Disability Inclusion Fund grantee convening in Chicago, Illinois!

This event was an amazing gathering of leaders from disability communities across the U.S., both in person and virtually. Over three days, we dove into workshops and discussions that really energized our work. We swapped stories, shared resources, and met so many incredible people doing fantastic work.

We connected with folks from all kinds of organizations, like those empowering individuals with developmental disabilities to advocate for themselves within their communities, civil rights education and enforcement centers, dance and theater groups, and nonprofits working to end violence in deaf communities, just to name a few.

Discussions covered everything from health and policy to community organizing, and even the breakout sessions focused on the different challenges faced by organizations working in specific regions throughout the U.S. We also attended numerous workshops that provided a wealth of information, such as:

⁃ Online Toxicity and Disinformation

⁃ Building a Radical Disability Politic and Access-Centered Cultures

⁃ Imagining a Disability Justice Filled World

⁃ Building Campaigns that Win

And much more! Each session was full of insights and strategies that we can apply to our work. It was also extremely rewarding to connect with so many amazing advocates in the disability space.

The sense of community and shared purpose at Building Power Together was incredibly empowering. We came back from Chicago feeling energized and armed with new ideas and tools to push our mission forward.

Overall, it was an unforgettable experience, and we’re excited to put everything we learned into action!!

Comment for the Record Submitted to Senate Committee Hearing

Take a look at our comment for the record submitted to the Senate committee hearing on “Ensuring Affordable & Accessible Medications: Examining Competition in the Prescription Drug Market!”

Dear Chair Durbin, Ranking Member Graham, and Senate Judiciary Members:

We write to you as a generation of patients living with chronic and rare conditions such as Crohn’s disease, lupus, arthritis, and many others. For too long, young adult patients have been left out of conversations to address the high costs of medications that we rely on not only to survive but to thrive as we enter adulthood. Many of us know that a cure is not attainable in our lifetime, and we will rely on incredibly high-cost medications for our entire lives, meaning that innovation and fair prices are crucial to reaching our potential. As a young adult patient-led organization, we believe strongly that reforming the patent system to promote competition, incentivize innovation, and create more ways for the public to challenge patents is an opportune way for our community to have better futures. 

We implore you to personally consider the profound impact that reforming the patent system could have on young adult patients like us. We are finding work for the first time, navigating insurance changes, the possibility of pursuing further higher education, and financial instability, with the added stress of affording our prescription medicines. 

We see clear opportunities to address patent abuses that are keeping the price of critical prescription drugs high, including pay-for-delay tactics, patent thickets, and product hopping. We also are thrilled to see steps in the right direction, such as the collaboration between the United States Patent and Trademark Office and the Food and Drug Administration. These reforms would benefit patients and foster a more competitive and innovative pharmaceutical industry. 

Competition will lower our drug prices: Our community members are on high-cost medications such as Nurtec ODT, Stelara, and Eliquis - all of which have extremely high prices and tremendous patent abuse. Many of us are also living with highly complex conditions requiring multiple prescription medicines. And the price relief we expect from competition through biosimilars and generics being introduced into the market has been delayed for far too long. Access to prescription medications is a basic human need. According to the Georgetown University McCourt School of Public Policy, 53% of people ages 18-34 use prescription drugs. Moreover, 21% of people ages 18-49 years old say they have difficulty affording their medication. The share is likely to be even higher for younger adults, given that the subgroup 18-24 has one of the highest poverty rates. This is a moment to ensure our community is well-represented as you consider the impact of high drug prices on the current and next generation of patients.

Innovation is particularly crucial for young adult patients: As young adult patients who will rely on therapeutics throughout our lifetime, we hope for new and better inventions that can benefit our community. Many of us cycle through therapeutics frequently, meaning that what is in the pipeline could be life-saving and life-changing. For patients in our community with rare conditions without prescription medicines left for us to try, we are navigating many changes in treatment options. Promoting true innovation could give many people the tools to increase their functionality and ease the pains of living with a chronic illness. 

Increase public participation in the patent system: Patients and public interest groups should have clearer opportunities to engage in the patent system. Instead of scaling back opportunities to challenge invalid patents, we need to create more opportunities. While we spoke at the USPTO-FDA listening session in January 2023 and have engaged in other ways, we look forward to seeing more meaningful opportunities for patients to be included. 

Indeed, we are grateful for the research and development of public-private partnerships that have contributed to bringing life-saving therapeutics to market. Over 85% of young people with chronic conditions are now surviving into adulthood, many of whom live with complex, lifelong conditions. However, pharmaceutical companies exploiting loopholes in the patent system make these life-saving drugs unaffordable and inaccessible. As more young people are being diagnosed with chronic conditions, it is crucial that we urgently activate policies that can reform the patent system for now and in years to come. Thank you for your time and for including our perspectives on this critical and timely issue. 

Sincerely, 

Generation Patient 

admin@generationpatient.org

Take a look at our Patent Reform Primer!

Why should young adult patients care about patent reform? Why does it matter, and how can you learn more? Check out our Patent Reform Primer!

Many young adult patients with chronic and rare conditions require a lifetime of access to treatments and therapies, costing them thousands and thousands of dollars.

Unfortunately, the pharmaceutical industry abuses loopholes in the patent system to increase profits and, as a result, patients are often denied access to more affordable alternatives and are unable to afford the prescription medications they need to live.

To ensure affordable access to essential medication, these abuses of our current patent system must end. This primer is meant to educate young adult patients in our community by briefly introducing the different patent abuse practices employed by brand-name pharmaceutical companies.

If you have any questions or comments about our primer, please contact us at admin@generationpatient.org!

Updates From our Peer-Support Roundtable!

This blog post is part of a series about our PCORI Engagement Award - we will post updates on our discussions every few months, so you can follow along! 

Last year, we shared that Generation Patient received an Engagement Award from PCORI (Patient-Centered Outcomes Research Institute) to “engage in patient-centered outcomes research and comparative effectiveness research (PCOR/CER) to assess peer support as a crucial intervention for young adults with chronic conditions.” 

Want to learn more about what this means? Interested in the work we’re doing? Read on! :) 

What are “patient-centered outcomes research” and “comparative effectiveness research”?

Simply put, patient-centered outcomes research (PCOR) addresses issues that patients have concerns about or are interested in rather than focusing just on the interests of researchers or medical providers. In PCOR, patients are included in every step of the research process—we’re not just the “test subjects” but also help design research questions, create studies, and discuss results! 

Comparative effectiveness research (CER) looks at multiple ways of addressing a problem and compares how effective each solution is. For example, comparative effectiveness research might be helpful if we want to know if treatment A or treatment B is better for treating a specific medical issue. Or, we might want to know if a specific action (ex: watering your plants every week) leads to better outcomes (healthier plants) when compared to another action (watering every 2 weeks). 

What is an “intervention”?

In clinical research, the specific action or treatment that you’re studying (often to see if it helps improve health/well-being in some way) is referred to as the intervention. So, in the above examples, our interventions were “taking treatment A” or “watering the plants once a week.”   

What is Peer Support?

There are a variety of different definitions of peer support - for our purposes, peer support refers to supportive connections between young adults living with similar chronic conditions/medical disabilities or navigating similar life challenges. Peer support can take many different shapes, such as:

• talking one-on-one with a friend who has the same diagnosis

• joining a virtual group to talk through different topics

• or even connecting with other folks in the chronic illness community from around the globe via social media! 

While there are many benefits to other forms of support (like therapy, hospital-based groups, etc.), we think peer support is special! There’s something inherently powerful about talking with others who understand what you’re going through and have been through similar things. At GP, one of the ways we define ‘peer support groups’ is based on who leads/creates these spaces - which is why all our groups are run by members of our community (young adults living with chronic conditions). 

So what does this mean? Putting the pieces together:

We’re interested in highlighting the importance of peer support *as an intervention* for young adults with chronic conditions. Essentially, we want to show that peer support is an important way to address some of the challenges that young adults with chronic conditions face! 

Don’t we already know peer support is helpful?? Why is this research important, and what are you going to do with this research? 

While there is existing research that shows that young adults with chronic conditions could benefit from increased mental, emotional, and social support in general (Nearchou et al., 2019), there is not much out there examining how peer support can be beneficial specifically! 

Even if we already know (from personal experience) how important peer support can be, it’s also important to have research that shows the impact of peer support as an intervention. Peer support programs are generally seen by the medical field as “extra” services: they are nice to offer patients if the resources exist, but are not seen as a critical aspect of treatment. But in our experience as young adult patients, peer support is a HUGE part of addressing our mental, emotional, and social well-being. If we can point to research that shows peer support is clinically beneficial (has measurable/observable benefits) for patients, this helps show why medical systems should invest resources and funding into these types of programs. 

Right now, we’re working on showing WHY there’s a need for this research, laying out the current challenges in doing this research, and looking at opportunities to further develop this research.

Interested in following along with our roundtable discussions? Stay tuned for more updates on some of the research we’ve reviewed so far and some of our key takeaways from these meetings!