SANDERS

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For decades, the only treatment option was a combination of calcium and active vitamin-D supplements. Finding the right balance is extremely difficult. Too little can lead to calcium crashes, but too much can cause organ calcification.

Then, in 2015, everything changed. The FDA approved the first parathyroid hormone therapy — called Natpara — as an adjunct therapy for hypoparathyroidism to be used with supplements.

For a few brief years, our lives changed. Patients felt their conditions were better controlled for the first time ever.

But last year, the FDA raised concerns about the possible danger of small rubber particles from the delivery device contaminating the drug, leading the manufacturer to take the treatment off the market through a voluntary recall initiative.

Gaining — and then losing — an effective treatment has been gut-wrenching for people with hypoparathyroidism.

Frustratingly, it's unclear when the manufacturer will be allowed to reintroduce Natpara to the broader market. For the foreseeable future, the overwhelming majority of patients are stuck with supplements as a standard of care treatment.

The FDA has done an amazing job of granting rapid preliminary approvals and authorizations of treatments for COVID-19.

It's time for the agency to show that same urgency for Americans suffering from hypoparathyroidism — by bringing Natpara back to market and giving all patients access to new and promising medicines that have been proven safe in clinical trials. There's no reason for these patients to suffer any longer.

Bob Sanders is chairman of the Hypoparathyroidism Association. This piece originally ran in The Washington Times.