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Pharmaceuticals / Regulatory Affairs

FDA Warns Online Distributors for Marketing Unapproved Abortion Pills

March 20, 2019
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The FDA hit two online entities with warning letters after discovering they sold combination packs of unapproved abortion pills over the internet.

The two companies — Rablon and Aidaccess.org — were found to be selling combo packs of the abortion medications mifepristone and misoprostol that were not approved by the FDA.

“Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight,” the agency noted. “Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”

The agency expressed concern over the two companies’ distribution of the products because the prescription of Mifeprex (mifepristone) is protected by a REMS program and cannot be legally purchased in retail pharmacies or over the internet. The drug’s possible complications, which are detailed on a boxed warning on the labeling, include serious or fatal infections and prolonged heavy bleeding, which could be signs of a failed abortion or other issues.

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