The ongoing drug shortage crisis has plunged families across America into turmoil, threatening the lives and well-being of those battling various medical conditions. These shortages are far- reaching and deeply personal.
PatiI want to start by thanking the FDA for hosting this listening session and for being the most proactive federal agency in seeking comprehensive solutions to address the drug shortage crisis. I recognize drug shortages cannot be solved by FDA alone. Some of my recommendations fall outside the scope of the agency, but I share them with you in hopes that FDA will continue to be the leader and catalyst for change. If not you, who will step up?
I am MacKay Jimeson, Executive Director of Patients Rising. I like to say that Patients Rising is in the business of patient empowerment. We serve our network of 100,000 plus chronic disease patients and caregivers through advocate development, direct patient support through our helpline, patient-inspired health policy, and storytelling.
Today, I want to share some stories with you today on how drug shortages are impact families across America.
Recently I spoke with Maggie in Florida, whose daughter Bridget has Prader-Willi Syndrome (PWS). For Bridget, who celebrates her seventh birthday today, growth hormone therapy has been a lifeline. This rare disease requires consistent treatment to enhance growth, development, and quality of life.
Sadly, Bridget’s young life is not only battling a difficult disease, but also access to the growth hormone she needs. Maggie has relentless struggle for even partial doses of the treatment for Bridget. The emotional toll on parents like Maggie is immeasurable, adding to the already overwhelming challenges of raising a child with PWS. This crisis underscores the urgent need for a resilient pharmaceutical supply chain to ensure consistent access to life-changing treatments for vulnerable populations.
Six year Breast Cancer survivor Jessica from Tennessee shared with me several horror stories from the cancer community. As you know, they have been hard hit by these shortages. Jessica tells me that patients find themselves unable to access vital chemotherapy treatments, while oncologists face the heart-wrenching task of determining which patients are most “worthy” of receiving the limited supply of life-saving drugs. I think we all agree that decreasing dosages, rationing supplies, and altering drug regimens is unacceptable in the American health system.
This crisis also hits close to home. I am a father of a ten-year-old boy, who is an asthma and allergy kid. The shortage of albuterol at hospitals is terrifying. While my son is typically able tomanage his asthma with an inhaler and an occasional at-home nebulizer treatment, once a year he experiences an asthma attacks so severe that we have to rush him to the emergency room. At the hospital he is given multiple doses of albuterol to help him breath. The thought that this life- saving medication might not be available when needed most is terrifying. Albuterol, one of the top ten most prescribed medications in the U.S., has been in short supply since summer 2022.
As you know, drug shortages have reached a decade high and are lasting longer. The fundamentals of the generics markets are broken.
Drug shortages are just one of the many ripple effects of business consolidation into massive healthcare conglomerates.
Like so many problems in healthcare, misaligned incentives are to blame. Organized medicine is invested in power and short term financial engineering, not the long term health and well-being of patients.
Group Purchasing Organizations and Pharmacy Benefit Managers, who are subsidiaries of health conglomerates, use their significant market power to force a “race to the bottom” on pricing.
This downward pricing pressure leads to reduced margins for manufacturers, causing some to exit the market, discontinue production of certain drugs, or have insufficient resources to maintain their production lines.
The focus on cost reduction can lead to a lack of redundancy in the supply chain, making it more susceptible to disruptions when a single manufacturer faces problems.
The Federal Trade Commission (FTC) must exercise its enforcement authority to prevent unfair methods of competition from GPO’s and PBM’s, and more broadly with their parent companies.
The Federal government has also contributed to the complexity and power imbalance in healthcare with too many funding streams, too many rules, and too little accountability for patient health and wellbeing.
We need to bolster domestic generic manufacturing production in America to counterbalance our international reliance on a single geographic region or manufacturer.
In the interest of time, I want to lay out at a high-level five critical reforms.
- Strengthen Domestic Generic Manufacturing:
- Strength national/regional stockpiles of medicines and raw materials
- Advocate for tax incentives to expand S. manufacturing facilities and encourage backup facilities and/or suppliers for critical ingredients and materials
- Improve FDA Processes:
- Facilitate reciprocal approvals from trusted regulators
- Alleviate burdensome data requirements
- Improve efficiency of facility reviews
- Reform Medicaid Generics Penalty:
- Eliminate the Consumer Price Index (CPI) Rebate for generics
- Exempt multisource generics from the CPI Rebate
- Exempt shortage-prone generics (e.g., sterile injectables) from the CPI Rebate
- Address DEA Constraints:
- Review pain management policies to balance abuse prevention and patient care
- Tackle Unexpected Barriers:
- Eliminate unnecessary access barriers, like prior authorization that can exacerbate a shortage from a patient experience
- Address issues like schools not accepting generic alternatives (e.g., generic EpiPens) due to training issues.
Patients need the FDA to continually urge Congress and other federal agencies to take the required action to ensure patients have affordable access to the medicines they need…when they need them.
Drug shortages are not just a supply chain issue – they’re a human issue. They represent missed doses, altered treatments, and lives at risk. I thank the FDA for your leadership and urge you to continue to be the catalytic for comprehensive policy solution. We must act now to ensure that no more families have to face the fear and uncertainty that comes with not having access to the medications they desperately need.
Thank you.