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Texas AG investigating whether pharma companies deceptively advertised puberty blocking drugs

Transgender
A sign outside a classroom taken in 2016. |

The attorney general of Texas is demanding documents from the manufacturers of puberty-blocking drugs as part of an investigation probing whether they have engaged in practices that violate state law.

Last week, the office of Texas Attorney General Ken Paxton released a statement announcing that it had issued Civil Investigative Demands (CIDs) to AbbVie Inc. and Endo Pharmaceuticals, Inc.

The demands are part of an investigation to "determine whether these manufacturers of puberty-blocking drugs deceptively advertised and promoted hormone blockers for unapproved uses without disclosing the potential risks to children and their parents.”

“Companies should never promote or supply puberty blockers for uses that are not intended or approved,” Paxton said. “I will not allow Big Pharma to misleadingly promote these drugs that may pose a high risk of serious physical and psychological damage to Texas children who cannot yet fathom or consent to the potential long-term effects of such use.”

The attorney general’s office contends that the medications at issue — Supprelin LA and Lupron Depot — have approval from the U.S. Food and Drug Administration to treat children with Central Precocious Puberty, a condition in which puberty comes early for a child. 

While Lupron has also “been prescribed for palliative treatment of prostate cancer,” neither drug has been approved as a treatment for gender dysphoria by the FDA. 

Steven Robinson, the chief of the Consumer Protection Division at the attorney general’s office, wrote the letters to AbbVie Inc. and Endo Pharmaceuticals, Inc.

“The Division believes that you are in possession, custody, or control of documentary material relevant to the subject matter of an investigation of actual or possible violations of the [Texas Deceptive Trade Practices Act] sections 17.46(a) and 17.46(b) related to the advertising, marketing, promotion, sale and distribution of prescription hormone blockers for off-label usage,” Robinson’s letter reads. 

Both companies have until April 14 to provide the state with the “documentary material” requested.

Robison’s letters stressed that “any person who attempts to avoid, evade, or prevent compliance, in whole or in part, with this directive by removing, concealing, withholding, destroying, mutilating, altering, or by any other means falsifying any documentary material may be guilty of a misdemeanor and on conviction is punishable by a fine of not more than $5,000.00 or by confinement in the county jail for not more than one year, or both.”

The “documentary material” requested of the drug manufacturers includes “documents sufficient to identify all hormone blocker products that you sell, market, or distribute or have sold, marketed, or distributed from January 1, 2019, to the present.”

The state also seeks “all documents related to the marketing and promotion of hormone blockers in Texas, including all branded and unbranded marketing materials, advertising, and educational materials, that contain information regarding the usage of hormone blockers, and/or off-label uses of hormone blockers.”

Additionally, the state is asking the drug manufacturers to provide all evidence of any investigations and lawsuits filed against them because of “representations made by you about the safety or effectiveness of your hormone blocker products or hormone blockers generally for the treatment of gender dysphoria.”

Other documents sought as part of the demands include correspondences with healthcare providers in Texas regarding the drugs, marketing and sales plans, and training materials for their employees.

The letters also asked for the production of all peer-reviewed articles that “in any way relates to any of your hormone blocker products” and all documents “concerning misuse, adverse events, side effects, and/or injury from your hormone blocker products.”

The demand letters are the latest action taken by the Texas Attorney General’s Office and the state government expressing disapproval of puberty-blocking drugs and promoting gender transitions for minors.

Paxton first indicated his intention to investigate AbbVie Inc. and Endo Pharmaceuticals Inc. under the Deceptive Trade Practices Act late last year. That move came not long after the Texas Department of Family Services characterized “genital mutilation of a child through reassignment surgery” as “child abuse” following a request from the state’s Republican Gov. Greg Abbott.

Last month, Paxton issued a formal opinion asserting that certain sex-reassignment procedures and treatments “can legally constitute child abuse under several provisions of chapter 261 of the Texas Family Code.”

As Paxton unveiled the opinion, Gov. Greg Abbott issued a directive ordering the Texas Department of Family and Protective Services to “conduct a prompt and thorough investigation of any reported instances of these abusive procedures” taking place in the state.

A state appellate court judge struck down the directive earlier this month, and Paxton’s office has filed a request for emergency relief with the Texas Supreme Court in an effort to reverse the lower court decision.

The debate about puberty blockers has received increased attention in recent years, particularly after “60 Minutes” aired a segment featuring testimony from “detransitioners,” those who began to transition from one gender to the other only to regret doing so later.

The young adults on the panel interviewed by CBS correspondent Lesley Stahl agreed that they were rushed into “hormones and surgery” without completely understanding the long-term impacts of taking that course of action.

The conservative American College of Pediatricians has warned that the use of puberty-blocking drugs for gender identity purposes on children can cause infertility. Critics claim providing such drugs to children struggling with their gender identity would sterilize otherwise physically healthy children.

Opponents argue that since the drug is not approved by the FDA for such a purpose, prescribing puberty blockers to children struggling with gender dysphoria should be seen as experimental. 

However, the left-leaning American Academy of Pediatrics has voiced support in the past for the surgical and hormonal transition of transgender children and adolescents.

Ryan Foley is a reporter for The Christian Post. He can be reached at: ryan.foley@christianpost.com

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