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Injectable Estrogen Shortage

Par and Perrigo Pharmaceuticals Urged to Address and Remedy the National Shortage of Injectable Estrogen

570 Signatures Collected Calling for Action; New York City First Lady Chirlane McCray among Signatories

Callen-Lorde Community Health Center is leading a national coalition – with partners from Fenway Health in Boston and Treatment Action Group in New York City – that has collected 570 signatures for a petition calling on pharmaceutical companies Par and Perrigo to address and remedy the national shortage of injectable estrogen.

In July, Callen-Lorde warned of potential public health risk for transgender women and transfeminine people due to a nationwide shortage of some generic and brand name injectable estrogen.  At that time, the makers of the drugs reported manufacturing delays in getting the medications to the market.

A sign on letter was circulated nationally. In New York City, First Lady Chirlane McCray – in her capacity as Co-Chair for the Commission on Gender Equity – signed the letter.

“The downstream medical and mental health implications from interruptions of life-sustaining therapies that keep transgender women engaged in healthcare are dire,” said Dr. Demetre Daskalakis, Assistant Commissioner for the NYC Health Department’s Bureau of HIV. “It is critical that this shortage of injectable estrogen be addressed as the emergency that it is.”

After the letter was delivered in September, Callen-Lorde heard from Par Pharmaceutical President Paul Campanelli, who said that a new raw material in the Delestrogen requires FDA approval. He stated that the product was manufactured, and they estimated FDA approval would be received by early 2017. He also expressed that the company understood the importance of the product to the American consumer.

Callen-Lorde has heard that Perrigo, which manufacturers the generic counterpart, estradiol valerate, is expected to restock the drug in October.

“The lack of injectable estrogen for our transgender women patients is a public health crisis,” said Wendy Stark, Executive Director of Callen-Lorde. “We’re pleased that this issue is getting the attention it deserves and remain cautiously optimistic that the pharmaceutical companies and FDA can restock these life-saving drugs.”

Hormone therapy to affirm gender identity is a medically necessary intervention for many transgender individuals. Support from public health providers and community alike has elevated the issue in the press.

UPDATE (10/05/16): We received communication from a representative of the FDA on October 5th that the 40 mg/mL and 20 mg/mL  injectable dosages of Estradiol Valerate are anticipated to be released to market in November. We will continue to make updates as we receive them.