HUGE UPDATE: There may finally be a path forward on the FDA labeling issue ❤️

When I started this petition, my goal was to push for change around the lack of an FDA-approved heart transplant indication for Everolimus: an issue that became very real for me when my insurance used the labeling surrounding heart transplantation during my fight for access to my anti-rejection medication.

For months, I have contacted Novartis, reached out to elected officials, received a response from the FDA, gathered more than 7,000 petition signatures, and continued asking the same question:

Is there a path forward for Everolimus and heart transplantation in the United States?

Now, for the first time, people with direct experience in this area are actively exploring that question with me.

Dr. William “Bill” Fitzsimmons, a transplant immunosuppression and drug-development expert who previously worked on expanding the transplant indication for another immunosuppressant, reached out to me after seeing my CNN story.

Bill had already raised the Everolimus heart-transplant labeling issue in comments to the FDA, and after learning more about my advocacy, he suggested exploring potential regulatory pathways forward.

His first choice is to find the right people at Novartis and see whether they would be willing to move this forward with our help. Bill is taking the lead on that outreach through his contacts.

At the same time, we're exploring another possibility.

Bill reached out directly to Mark Cuban, who has previously helped amplify my advocacy, about whether Mark Cuban Cost Plus Drug Company could potentially play a role in exploring a regulatory pathway.

Mark responded and brought others into the conversation.

Warris Bokhari then connected us with Ahmed Ragab, CEO of PKx Bio, who told us he is very familiar with both Everolimus and the regulatory pathway being discussed. Ahmed was attending a major 505(b)(2) conference in Milan and offered to speak with generic manufacturers there, gather information about whether anyone may already be working on this issue, and then regroup with us to develop a game plan.

I want to be VERY clear about where things stand:

No FDA application has been submitted. No company has committed to sponsoring one. And there is absolutely no guarantee that this will result in an FDA label change.

Right now, this is exploration.

But it is exploration involving people who understand transplant drug development, regulatory pathways, pharmaceutical companies, and the medication-access problem that brought me here in the first place.

And that feels like progress.

I started this petition because I didn't want what happened to me to simply become another insurance horror story that everyone forgot about.

I wanted someone to ask whether we could actually address one of the underlying problems.

Now those conversations are happening.

I don't know where they will lead yet. But I'm incredibly grateful to Bill, Mark, Warris, Ahmed, and everyone else willing to ask the question with me:

Can we find a path forward for Everolimus in heart transplantation?

More than 7,000 of you have signed this petition.

Please keep sharing it. ❤️

We're not done.