The pro-choice advocacy group Aid Access distributes abortion-inducing drugs from abroad to women without mitigating the many risks of medical abortion.
A Aid Access, a radical abortion advocacy group, has taken the practice of telemedicine to a new level, prescribing the medical abortion drug RU-486 via an internet connection to a foreign doctor, who then runs the shipment of the two induced-abortion drug pills to women in America and elsewhere.
But the practice is completely illegal in the United States. Now, the Federal Food and Drug Administration (FDA) has decided to shut down Aid Access’s operations here. After reviewing the Aid Access website, the agency issued a warning letter to the group last Tuesday, ordering it to “immediately stop” introducing “mislabeled and unapproved new drugs” to the market in violation of federal law.
The Aid Access website states:
Aid Access supports women who cannot access local services. If you are in good health and less than 9 weeks pregnant, you can do the consultation online. Mifepristone and misprostol abortion pills will be delivered to you by post.
For Aid Access, it is a question of justice: “Aid Access supports women who cannot otherwise access an abortion and protects their human rights.
For the FDA, however, it is a matter of women’s health and safety. The counterfeit versions of the overseas drug RU-486 that Aid Access sends to women have not been approved as “safe and effective”, as all drugs sold in the United States must be.
In its letter to Aid Access, the FDA warned:
The sale of new, mislabeled and unapproved drugs poses an inherent risk to consumers who purchase these products. . . . Drugs that have circumvented regulatory safeguards may be contaminated; counterfeit, contain varying amounts of active ingredients, or contain completely different ingredients. . . . Sourcing drugs outside of the legitimate US drug supply chain can pose serious risks to patients who may receive counterfeit drugs that are not shipped and/or stored properly.
The FDA has approved the drug RU-486 Mifeprex for abortions up to ten weeks gestation. But Aid Access’ substitution of an unapproved abortion drug, the agency pointed out, “poses significant health risks to U.S. consumers” because the foreign drug is not subject to the special “black box” warning. which warns women of the “risk of serious abortion or even life-threatening side effects, including severe and sometimes fatal infections and prolonged heavy bleeding.”
Unlike Mifreprex, the Aid Access drug is also not subject to the Risk Assessment and Mitigation Strategy program, which aims to mitigate the risk of serious complications by requiring vendor certification for prescribing and dispensing. distribution of Mifeprex and informing patients of the serious risks of Mifeprex. For this reason, the agency added, “Mifeprex is not sold in retail pharmacies or on the internet.”
The FDA may also have considered Aid Access’ seemingly nonchalant approach to the very real threat of a dangerous ectopic pregnancy, which affects one or two in every 100 pregnancies.
“You can make sure your pregnancy is inside the womb by having an ultrasound,” Aid Access said. website suggests. “If you’re using mifepristone and misoprostol to end a pregnancy and you don’t do an ultrasound first, there’s always a chance you’ll have an undetected ectopic pregnancy.”
But access to help does not work require an ultrasound before the abortion, as required by the standard of medical care. The FDA therefore warned Aid Access that since its foreign drug is “intended for a condition that is not amenable to self-diagnosis and treatment by a layperson, adequate instructions cannot be written so that a layperson can use the product safely for its intended use.”
And despite aid from Aid Access acknowledgement that no woman should have a medical abortion unless she is within 60 minutes of an emergency department, the group has no procedures in place to ensure that its clients are located within this range of access to emergency care for about one in ten cases requiring surgical performance of a medication-initiated abortion.
The FDA requires provider certification to ensure that the prescriber has the ability to assess the gestational age of pregnancy and to diagnose ectopic pregnancies, and to schedule surgery for incomplete abortion or serious bleeding – all the risks that Aid Access seems to ignore.
Career bureaucrats at the FDA extended the use of RU-486 at the behest of the abortion industry just two years ago, so they’re certainly not addressing life advocates here. In fact, the FDA website warns women, “You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others). The agency’s warning letter ends with the threat of “regulatory action, including seizure or injunction, without further notice.”
Therefore, one would expect Aid Access to reconsider its position, if not its entire purpose. The FDA has given Aid Access 15 days to respond, but don’t hold your breath. Pro-abortion activist groups such as Aid Access are rarely deterred from their extreme and dangerous positions by facts, even those that document a real threat.
Expect continued bluster, misinformation, and likely litigation, all of which put women’s lives at risk. Hopefully, the FDA will soon follow through on its threat and end Aid Access’s reckless advocacy. Congress should also act quickly to exercise proper oversight and ensure the FDA and Postal Service are doing their job to protect Americans from substandard drug suppliers.