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Action Alert: Injectable Estrogen Shortage

The national shortage of injectable estrogen persists — and continues to be a public health crisis.

Callen-Lorde is at the forefront of a national effort to demand that injectable estrogen products are returned to the market. In September, we co-authored a sign-on letter to Par and Perrigo Pharmaceuticals – the companies that manufacture the brand and generic versions of the drug – along with our colleagues Fenway Health and Treatment Action Group (TAG). The letter yielded 570 signatures from physicians, public health professionals and institutions, advocates and members of LGBTQ communities from across the country.  Since then, we’ve heard that the brand name drug will be available in early 2017 and the generic brand in December 2016 (a delay from the original date of November 2016). We’re in communication with the FDA’s Office of Health and Constituent Affairs, as well.

Joining again with Fenway Health and TAG, Callen-Lorde has released an issue brief which explains why the FDA and pharmaceutical companies’ failure to provide injectable estrogen to transgender individuals is a violation of their right to comprehensive medical treatment, free of discrimination. We propose short and long term solutions to this shortage, and offer ways in which individuals and organizations can contribute to this ongoing effort.

As we transition to a new and unknown national healthcare landscape, this is more important now than ever.

In the meantime, the FDA is now requesting input for all stakeholders – including consumers and activists – to better understand the pros and cons of the limitations on what a manufacturer can and cannot tell healthcare providers about the off-label uses of medication. You may also include any additional comments you would like the FDA to consider (i.e. demanding the FDA take a more proactive role in gaining agency-regulated approval for hormones used for gender affirmation)

Make your voice heard on this issue by submitting comments via email or in writing to the FDA! The deadline is January 9, 2017.

Consider these questions when submitting your comments:

  • How could off-label drug promotion impact care and treatment for transgender women and men?
  • How should manufacturers of these drugs used for feminizing or masculinizing purposes prioritize the safety and effectiveness research that is necessary to support FDA approvals for transgender men and women?
  • How will the promotion of off-label drugs impact incentives for manufacturers to do this research?
  • How should the FDA go about considering whether or not off-label use information is truthful and non-misleading?
  • How should the FDA regulate off-label communications to ensure they are not misleading or harmful?

TO ADD YOUR COMMENTS VIA THE WEBSITE:
Go to: http://www.regulations.gov
Copy and paste this docket number FDA-2016-N-1149 into the ‘search’ field
Click “Comment Now!”
Enter your information

TO SEND YOUR COMMENTS IN WRITING:

Mailing Address:
Division of Docket’s Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Include “Comments on docket number FDA-2016-N-1149” as a subject at the top of your letter.

Take action now and make your voice heard!