FDA clamps down on sale of unapproved mail-order abortion pills

Catholic News Agency | 3/14/2019 | Staff
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Washington D.C., Mar 14, 2019 / 04:01 pm (CNA).- As part of a wide-reaching crackdown on the online sale of illegal drugs, the US Food and Drug Administration has warned several online providers of abortion-inducing medications to stop the sale of unapproved abortion pills.

The FDA sent last week a letter to Rablon, an online pharmacy network, and Aid Access, requesting they immediately desist selling unapproved versions of the abortion drugs mifepristone and misoprostol online.

FDA - Warning - Letter - Sale - Drugs

According to the FDA warning letter, the "sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products."

"Drugs that have circumvented regulatory safeguards may be contaminated; counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether," the letter states.

Mifepristone - Misoprostol - Drugs - Abortion - Miscarriage

Mifepristone and misoprostol are two drugs taken together to carry out a medical abortion. They work by inducing miscarriage in pregnancies before 10 weeks.

FDA-approved versions of the drugs have been available to US consumers since 2000, but may only be prescribed by a certified health care provider in a hospital, clinic, or medical office setting. They may not be sold online or in a retail pharmacy.

Health - Care - Provider - Patients - Risks

The health care provider must inform patients about the serious risks associated with use of the medications, and sign a waiver certifying the patient has access to emergency care or a surgical abortion in the case of complication.

These requirements are part of an FDA risk mitigation program called REMS, which is used for all higher-risk medications.

Letter - Aid - Access - Version - Mifepristone

The letter to Aid Access stated that the FDA-approved version of mifepristone, called "Mifeprex," is...
(Excerpt) Read more at: Catholic News Agency
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