HYDE-SMITH JOINS CASSIDY INVESTIGATION INTO ABORTION DRUG MAKERS

Pro-Life Senators Also Seek FDA Crackdown on Illegal Chemical Abortion Drug Online Sellers

WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.), chair of the Senate Pro-Life Caucus, along with U.S. Senator Bill Cassidy, M.D. (R-LA) and others, today began an investigation into chemical abortion drug manufacturer compliance with Food and Drug Administration (FDA)-mandated safeguards associated with marketing their drugs.

Pro-life lawmakers sent a letter to the FDA that encourages the agency to use all of the tools at its disposal to combat the sale of unapproved and misbranded versions of chemical abortion drugs in the United States.  They also signed letters to chemical abortion drug manufacturers seeking information on online prescriber compliance with even the minimal risk evaluation standards that remain on chemical abortion drugs like Mifepristone.

“Given the potentially life-threatening risks to women, the FDA should take immediate action to fight the sale and distribution of unapproved and misbranded versions of chemical abortion drugs,” said Senator Hyde-Smith, author of the SAVE Moms and Babies Act.  “We know that more than 1 in 10 women who take Mifepristone will experience a serious adverse event, a situation that is made worse with these questionable variants in circulation.  Even under proper safety protocols, this drug is sold for the primary purpose of ending life and deserves heightened scrutiny.” 

“Chemical abortion drug makers profit off killing innocent children while putting mothers’ lives at risk,” said Dr. Cassidy.  “These manufacturers and websites have facilitated the explosion in online sales of these harmful drugs without regard for women’s health and safety while opening the door for coercion and abuse.  FDA should act within its existing authorities to curb this abuse and immediately reinstate safeguards such as the in-person dispensing requirement.” 

Previous Democrat administrations removed the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program requirements for reporting non-fatal adverse events and in-person dispensing to receive the chemical abortion drugs, among other important safeguards.  Ending these requirements has led to instances of coerced abortions and serious adverse events going untreated and undetected.

Despite these dangers, it is unclear how the three FDA-approved chemical abortion drug manufacturers, Danco, GenBioPro, and Evita, ensure that prescribers and pharmacies comply with the few remaining REMS requirements, especially when pills are sold online and without the in-person oversight of a medical professional.

In addition, various types of domestic and international websites appear to sell unapproved and misbranded chemical abortion drugs illegally and directly to U.S. consumers, often with no prescription, no medical oversight, and no assurances on whether the drug is actually what the seller claims it is.  

Cassidy spearheaded the letters as chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee.  In addition to Hyde-Smith, they were also signed by U.S. Senators Steve Daines (R-Mont.), James Lankford (R-Okla.), and Lindsey Graham (R-S.C.).

Susan B. Anthony Pro-Life America, National Right to Life, Family Research Council, Live Action, and Louisiana Right to Life support the Senators’ efforts.  Read more here.

Read the full letter to FDA here.
Read the full letter to Danco here.
Read the full letter to GenBioPro here.
Read the full letter to Evita here.

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