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While some in Congress continue to claim the latest drug pricing plan in Washington is “negotiation,” that is far from the truth. The reality is that the current plan gives the government a new authority to set prices for medicines in Medicare after a product has been on the market for 7 (small molecule drugs) or 11 (biologics) years.

This is extremely problematic because as patients know all too well, innovation doesn’t and shouldn’t stop when the U.S. Food and Drug Administration (FDA) approves a new medicine, as we’ve discussed before. In fact, once a medicine is approved, researchers and scientists continue to build on the knowledge they have gained to determine whether there may be additional benefits for patients.

I recently had the chance to hear from Lauranel, a breast cancer survivor and grandmother from Louisiana; Christina, a student in Massachusetts who suffers from congenital pulmonary lymphangiectasia, a rare lung disease; and Tammie, an Illinois mother of five who lost her husband to ALS. As patients, survivors and caretakers, these individuals have an acute understanding of the very real potential consequences of this legislation.

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Andrew: Why is it important to you that the United States continues to lead the world in the innovation and access to cutting-edge therapies?

Lauranel: So many of the advancements in cancer treatment are the result of decades of American research and development. I feel fortunate to live in a country where I had access to the best treatments possible when I was fighting for my life.

Should my breast cancer ever return, I will once again need to have that same access to the best treatments possible. Even better, I have hope that one day scientists will have a tried-and-true cure for breast cancer.

However, if Congress moves forward with its current proposal to set the prices of medications like we see in other countries, I have real concerns that Americans will have limited access to types of therapies that saved my life, and we could miss out entirely on a future cure if research faces undue limitations.

Andrew: What do you see as the biggest threat to pharmaceutical innovation right now?

Christina: As someone who suffers from a very rare disease, the desire for new treatments are always top of mind. I personally find myself really worried about the impacts of Congress’s new prescription price-setting policy and what it could mean for innovation in the long run. Many of the treatment options for rare diseases, like mine, come from post-approval research. But now, Congress is looking to implement policies that would sow sand in the gears of this kind of research.

When I was born, congenital pulmonary lymphangiectasia had a mortality rate of 98%, so there is no doubt in my mind that I am only here today because of pharmaceutical innovation. And while I’ve survived and thrived much longer than the doctors could have ever anticipated, I still face complications from my condition every day. Without access to the newest and most advanced treatment options, my life will remain on the line. We need continued research to confront rare diseases like mine.

Andrew: Speaking of treatments for children and young adults, how do you think price setting might impact pediatric innovation?

Christina: So many of the medications and treatment options for children and young adults are the direct byproduct of post-approval research. Usually, a treatment will be made first for adults. Only then, after receiving approval from the FDA, will pediatric studies begin.

We saw this very process play out this past year, actually. Right out of the gate, the COVID-19 vaccines weren’t available to children. Only after extensive, post-approval studies were children able to receive vaccines. Without this valuable research, children would still be without protection from COVID-19.

For me, this is even more personal, though. I have lived with a rare disease since birth. Many of the medications that have enabled me to live a full and productive life are the direct result of post-approval studies. If not for this research, I don’t know if I would have had access to the care I needed to get to this point.

Andrew: As a result of Congress’s current government price-setting proposal and its discouragement of investment in R&D, there could be a reduction in the number of new cures and treatment options available to patients in the future. As an advocate for innovation, how does this make you feel?

Tammie: For me, this would be absolutely devastating. Tragically, 5-10% of all ALS cases are genetic. This means that any of my five children could have inherited the disease from my late husband. For me, that’s too much to bear. Watching my husband pass from ALS was, far and away, the hardest thing my family and I have ever endured, and if one of my children were to receive the same diagnosis, I don’t know what I would do.

One of those lost cures could easily be the one that makes a difference for ALS patients, and I’m just not willing to miss out on that. We need research to continue so that we might one day find a cure for ALS. Continued research could have the power to save my children and others from my husband’s fate.

Tell Congress to protect Medicare and focus on common-sense solutions that will help people access and afford their medicines.

Andrew Powaleny

Andrew Powaleny is the Deputy Vice President of Public Affairs at PhRMA, where he leads communications on scientific, regulatory and intellectual property issues, highlighting the biopharmaceutical industry’s efforts in developing innovative medicines and vaccines while promoting an environment that encourages necessary risk-taking. For five years starting in 2019, he launched and led PhRMA’s grassroots initiative, Voters for Cures, bringing patients and caregivers together to advocate for access to medicine and biopharmaceutical innovation. He also co-founded and co-chaired PRIDE Umbrella, a resource group for LGBTQ+ individuals. Prior to joining PhRMA in 2015, Andrew worked as a communications consultant in Washington, D.C., and as Deputy Press Secretary for the U.S. House Committee on Energy and Commerce under Chairman Fred Upton. He holds a degree in public policy and government from Eastern Connecticut State University, with a minor in music. Outside of work, Andrew enjoys exercise, musical theater and mentoring college students through The Fund for American Studies alumni association.

Andrew Powaleny

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