The ecosystem of plasma-derived medicines needs improvement in a state with insufficient centers

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OPINION — At 29, I developed a severe tremor in my right hand. Doctors initially blamed stress and caffeine. But as the weakness worsened, what followed were months of misdiagnosis and medical uncertainty, shuffling between specialists while my condition steadily deteriorated.

It took a year before I was finally diagnosed with multifocal motor neuropathy (MMN), a rare disorder where the immune system mistakenly attacks the nerves, causing muscle weakness. By then, the delay had caused irreversible muscle atrophy to my hand, but I was fortunate.

I was treated with the gold-standard treatment for MMN, intravenous immunoglobulin (IVIG), a plasma-derived medicine made possible only through human plasma donation. Within 48 hours of my first infusion, my condition improved dramatically. IVIG restored my ability to function, work and live independently. 

Then, just one year into monthly treatments, my health plan informed me it would no longer cover my IVIG therapy. I appealed. Drawing on my background in public health policy, I did what most patients can’t do alone: I brought California leaders to the table, including Gov. Arnold Schwarzenegger’s office, legislative health chairs and the U.S. Surgeon General, to highlight the inconsistent access to plasma-derived medicines, and the insurance barriers patients routinely face.

After three exhausting months, my health plan reversed its decision. But the letter approving my care asked me not to discuss my reinstatement with other patients, as they would not receive the same treatment.

I was outraged again. How was it acceptable that I got care only because I knew the right people? What about the millions of patients who don’t have that privilege?

That experience exposed a troubling reality facing patients across the country: Access to plasma-derived medicines is increasingly fragile.

Today, more than 20 million Americans live with neuropathy-related conditions, many relying on plasma-derived medicines to prevent disease progression. And MMN patients are far from alone.

These treatments are lifelines for individuals living with rare and chronic conditions, such as hemophilia, primary immunodeficiencies and alpha-1 antitrypsin deficiency, among a few. They’re also used in emergency settings to treat severe shock and burns, maintain blood pressure, and replace blood volume. Unlike other medicines, plasma proteins cannot be made in a lab. Every treatment depends entirely on donations from healthy individuals and a stable, reliable plasma collection system.

Despite California being home to more than 60 plasma collection centers, the state still does not collect enough plasma to meet its own demand and must rely on donations from other states. Part of the problem is that California’s regulatory framework governing source plasma donation still applies standards originally designed for blood banks collecting blood for transfusions.

But source plasma donation is fundamentally different. It is a highly automated, specialized process with rigorous federal oversight and safety standards specifically tailored to plasma collection. Applying outdated and irrelevant regulations creates unnecessary operational barriers that limit plasma collection capacity, discourage investment, and constrain supply at a time when patient demand continues to grow.

For patients who rely on plasma-derived therapies, access is not abstract policy; it is the difference between stability and crisis. Yet too many families are forced to fight through insurance denials, treatment delays and supply uncertainty just to receive medically necessary care. That is why advocates, patient organizations and groups like the California Plasma Coalition are pushing for increasing access to plasma-derived medicines.

California has an opportunity and a responsibility to strengthen the plasma ecosystem and increase access to these essential medicines. Assembly Bill 2009, bipartisan legislation authored by Assemblymembers Phillip Chen and José Luis Solache, recently passed unanimously off the Assembly floor and now awaits action in the Senate. The bill would modernize regulations governing plasma collection centers and strengthen the plasma ecosystem into a reliable, robust supply that patients depend on.

Access to lifesaving plasma derived medicines should never depend on who you know, how loudly you can fight or how well you understand the system. It should depend on nothing more than medical need and on a health care system willing to ensure these medicines remain available for the people whose lives depend on them. 

Dominick Spatafora is president of Neuropathy Action Foundation based in California.