Our Patient Advocacy during the Covid-19 Pandemic's Uncertainty

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Over the last two years patient advocacy replaced face-to-face meetings with Zoom. It substituted highly-effective legislative fly-ins on Capitol Hill (and state legislatures) with unimpressive Twitter storms. And it left many organizations scrambling to find their place in this new world of uncertainty. The ADAP Advocacy Association isn't immune from the realities surrounding the Covid-19 pandemic, especially since we represent an immunocompromised constituency.

Photo Source: Hearts in Service Blog

In March 2020, we suspended face-to-face advocacy literally as we were preparing to host the year's first HIV/AIDS Fireside Chat in Atlanta, Georgia. Our organization opted not to host Zoom meetings because the Fireside Chats have a sense of intimacy about them, but also because we quickly learned that many stakeholders were experiencing what was labeled "Zoom fatigue" at the time. That decision carried into last year, too. Aside from a series of the virtual patient support meetings held both in 2020 and 2021, we've sat (in)patiently waiting for this pandemic to subside.

Fortunately, some of our national partners stepped-up their advocacy game and hosted extremely impressive virtual conferences. Among them, HealthHIV and its SYNChronicity 2020 (SYNC 2020), and the Biotechnology Innovation Organization (BIO) and its 2020 Patient and Health Advocacy Digital Summit. The ADAP Advocacy Association opted to fund scholarships for advocates and patients living with HIV/AIDS to attend these events. 

But we're optimistic about returning to 'normal' this year!

The ADAP Advocacy Association has targeted June 2022 for the resumption of the HIV/AIDS Fireside Chats, and other patient advocacy events. That will, of course, largely depend on the ever-changing circumstances on the ground, evidenced by what is unfolding before our eyes with the Omicron variant. It is our goal to host a Fireside Chat in Atlanta over the summer, and then Chicago in the fall.

In the meantime, we will continue to focus on the intersection between HIV/AIDS and Covid-19. In 2020, we awarded Covid-19 community grants to community-based, nonprofit organizations addressing the pandemic's impact on marginalized communities living with HIV/AIDS. In 2021, we launched #YourVaccineIsWaiting public awareness campaign targeting marginalized groups living with HIV/AIDS. This year, we will invest more of our resources into monitoring how Covid-19 is impacting our community, as well as encouraging immunocompromised populations to get vaccinated...and boosted! Their lives depend on it, literally.

Finally, we're excited to welcome our new ADAP Blog Guest Contributor, Ranier Simons, MHI. Ranier prides himself on data science capabilities to drive better healthcare. He recently earned his Master of Healthcare Innovation Health Informatics from Arizona State University - Edson College of Nursing and Health Innovation.

Patient advocacy, as we knew it, came to a screeching halt in March 2020. Then in 2021, patient advocacy experienced a roller coaster ride of ups and downs. It is too early to know what 2022 will bring, but the ADAP Advocacy Association remains optimistic about the future of the patient advocacy environment, and we stand ready to respond accordingly. We look forward to you joining us in this endeavor, too!

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Patients Ask FDA

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Last year while attending the Biotechnology Innovation Organization's ("BIO") Patient & Health Advocacy Summit in Washington, DC, an important, but little known patient resource was shared during one of the panel discussions. It involves the U.S. Food & Drug Administration ("FDA") and the ability of patients to and their caregivers ask questions to FDA or to request a meeting.

The Patients Ask FDA is an online portal located at https://www.fda.gov/patients/learn-about-fda-patient-engagement/patients-ask-fda.

This innovative, patient-center resource makes available information about ongoing initiatives on how to engage with the FDA, testimonials from FDA patient representatives, as well as how to apply to the FDA Patient Representative Program. It also includes current FDA Patient Listening Sessions, which are in partnership with the National Organization for Rare Disorders ("NORD").

The ADAP Advocacy Association places a premium on patient engagement and we encourages to use this important tool afforded to them by the FDA.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

BIO's 2018 Patient & Health Advocacy Summit

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association has long prided itself on building advocacy partnerships, and thus it is fitting that our organization's leadership — including board members Wanda Brendle-Moss and Jen Laws, as well as myself — was invited to attend the Biotechnology Innovation Organization's (BIO) 2018 Patient & Health Advocacy Summit in Washington, DC. What makes the annual event useful is it assembles the advocacy community, industry partners, regulators, academia, students, and of course, patients.

Susan Stein, MPH, who serves as CEO of the E4 Health Group, shared a simple, yet powerful characterization: "Partnerships between patient advocacy organizations and industry are more important than ever."

Photo Source: FierceAdvocate

The BIO 2018 Patient & Health Advocacy Summit brought together over 200 key stakeholders for two days of programming to discuss current policy issues, share best practices, and exchange ideas. Nearly two-thirds of the attendees represented the patient advocacy community. The BIO Summit also provided an invaluable opportunity to advance partnership among stakeholders in the healthcare ecosystem. Whereas the ADAP Advocacy Association's participation represented HIV/AIDS, there were many other disease groups in attendance, such as Psoriasis, Arthritis, Muscular Dystrophy, Metachromatic Leukodystrophy, and many more.

The BIO Summit immediately addressed the 800 pound gorilla in the healthcare ecosystem with an important pre-summit workshop on best practices for engaging with industry. As the patient perspective plays a more central role in the drug development process, it is recognized that clearer conflict-of-interest policies and best practices would better serve all stakeholders. The patient voice has moved beyond simply participating in clinical trials, and as a result industry and regulators are engaging patients earlier in the process. The 21st Century Cures Act includes a commitment to patient-focused drug development ("PFDD"). It amends the Federal Food, Drug, and Cosmetic Act to require the Food & Drug Administration to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.

The timing of the BIO Summit couldn't have been planned any better with the Trump Administration's latest announcement under its blueprint for prescription drug reform. The latest proposal would set up an international pricing index in an effort to drive down prescription drug costs under Medicare Part B, which in turn, could also drive down patient out-of-pocket costs. The U.S. Department of Health & Human Services ("HHS") Secretary Alex Azar discussed the "pro patient access proposal" at the BIO Summit, only hours after it was announced.

HHS's decision to announce an Advance Notice of Proposed Rulemaking ("ANPRM") translates into the patient advocacy community having ample time to weigh-in on it. It could very well be the case that the public comment period represents one of the times where the patient advocacy community and industry view things differently, but that is a good thing.

For a policy brief on the ANPRM, please visit: https://www.hhs.gov/about/leadership/secretary/priorities/drug-prices/ipi-policy-brief/index.html.

For a fact sheet on the ANRPM, please visit: https://www.cms.gov/newsroom/fact-sheets/anprm-international-pricing-index-model-medicare-part-b-drugs.

Comments on the ANPRM will be accepted until December 31, 2018 and may be submitted electronically through the CMS e-Regulation website at: https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/eRulemaking/index.html?redirect=/eRulemaking.

The ANPRM can be downloaded at: https://www.cms.gov/sites/drupal/files/2018-10/10-25-2018%20CMS-5528-ANPRM.PDF.