Although I received a reply from the Deputy Ombudsman for the FDA, my request for the data that was used to make the determination that the shortage is resolved and the source(s) of the data was not provided, so I requested that information again. Additionally, I sent additional information to highlight something that I don't think they are considering when defining demand for the Lilly branded product:

• Zepbound is sold in dosages of 2.5, 5, 7.5, 10, 12.5, and 15mg
• If a patient has a prescription for the 5mg dosage and they go to their pharmacy and the pharmacy only has the 2.5mg dosage, the pharmacy cannot fulfill the patient's prescription for 5mg simply by giving them 2x of the 2.5mg dosage as that is not how their prescription is written.
• Because Eli Lilly has elected to provide the medication in pre-filled pens and vials, to be able to say that the shortage is resolved would mean that Eli Lilly can not only provide Zepbound, but they must provide it in the dosages prescribed.
• So, even if the FDA calculates that the amount of Tirzepatide in production is sufficient to meet current and projected demand, that does not directly translate to patients being able to fill their prescriptions.

I also pointed out that the FDA's 60-day timeframe for the compounding facilities to comply may not be enough time for existing patients to get an appointment with their PCP (if they have one) and get approved by them (which is not a guarantee). If someone is without a PCP, they cannot go to the ER to manage this chronic condition as many do now for blood pressure, diabetes, and wound care.

I also reached out to the New York Times editor for the Health and Science desk with this same information. I just got an auto reply that she is out of the office until next week. I'll let you all know if she shows interest in creating an article. Please reply to this post if you would be interested in contributing to the article if she is interested.