By Dave Andrusko
On Monday, the FDA sent warning letters to two online entities for introducing “Misbranded and Unapproved New Drugs into Interstate Commerce,” specifically mifepristone and misoprostol, the two drugs that make up the “RU-486”abortion technique.
AidAccess.org and Rablon were told to immediately stop selling unapproved versions of the drugs and to “respond to FDA concerns within 15 working days outlining how it will correct its regulatory violations,” according to Julia Belluz of Vox.com.
In its letter to AidAccess, the FDA wrote
The sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
FDA requests that you immediately cease offering violative drugs for sale to U.S. consumers.
As Doug Mainwaring explained last year, Aid Access is a “website that purports to connect pregnant women with a ‘doctor’ for an online consultation via the internet, before being supplied with abortifacients mifepristone and misoprostol by mail. The website was created by Netherlands abortion activist Rebecca Gomperts.”
Rablon is “an online pharmacy network that includes at least 87 websites, such as AbortionPillRx.com and AbortPregnancy.com, directly selling mifepristone and misoprostol to patients,” Belluz wrote.
Belluz’s account provides a useful background, beginning with the bottom line: “Legal versions of mifepristone and misoprostol have been available to patients in the U.S. since 2000 — but patients can’t just get them at any pharmacy.
The drugs are only given out by certified health care providers in a doctor’s office, clinic, or hospital. The providers need to sign a waiver that they’ll ensure patients have access to a surgical abortion or emergency care if anything goes wrong — part of an FDA risk mitigation program called REMS, which is common to higher-risk medications.
When retailers sell unapproved versions of drugs outside of the REMS program — which the FDA says Aid Access and Rablon have — “FDA is well within its regulatory authority to take action,” said Tim Mackey, a UC San Diego School of Medicine expert on counterfeit drugs. (In the case of Aid Access, the pills are imported from India.)
Dr. Randall K. O’Bannon is NRLC’s expert on chemical abortifacients. He has followed pro-abortion attempts to “mainstream” so-called Do-It-Yourself abortion techniques, which are very dangerous.
“The promoters of these abortion pills tend to avoid mentioning it in all their papers and press releases touting the safety of at home use of mifepristone and misoprostol,” NRLC’s Director of Education & Research told NRL News Today, “but the FDA knows that thousands of chemical abortion patients have been hospitalized and nearly two dozen women have ended up dead.”
O’Bannon added
Despite all the pressure, and the high profile campaign of abortion researchers and advocates to get the medical establishment to give their blessing to at-home chemical abortions, there are still people at the FDA who look at the evidence and see drugs that come with serious risks and require, at a minimum, professional medical management. They also recognize that in their zeal to push these do-it-yourself abortions, these advocates have incautiously partnered with shady or sloppy foreign pharmaceutical companies who manufacture and ship drugs of which the FDA cannot guarantee the purity or safety. That they come without instructions or without clear safety warnings is reason enough for the FDA to halt the import of these drugs.