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Give Women Their Reproductive Revolution: It's Long Past Time to Remove the FDA's Unscientific Restrictions on the Abortion Pill

By: TxPEP investigator Daniel Grossman

Featured in U.S. News and World Report, September 30, 2016

Sixteen years ago this week, the U.S. Food and Drug Administration approved mifepristone, sometimes referred to as RU-486, for early medication abortion. Hopes were high back then that the drug would revolutionize abortion access, taking the procedure out of clinics and moving it into the privacy of women's homes. If every doctor in America – or at least every OB-GYN – could offer this option, women's access to abortion would improve dramatically. Women might also avoid protesters at abortion clinics if they could just go to their regular doctor.

Of course, things did not turn out this way. Few physicians who do not offer suction abortion provide mifepristone, so most women who want this method still have to go to an abortion clinic.

The reasons why access to medication abortion has been constrained are twofold. First, states have imposed restrictions on the method. Second, there are restrictions on how the drug itself can be distributed, thanks to the way it was approved by the FDA.

States limit access to medication abortion in a number of ways. In most states, only a physician can provide medication abortion, despite the evidence that this option can be safely provided by nurse practitioners, nurse midwives and physician assistants. About 19 states have also banned the use of telemedicine to provide medication abortion, even though research found this model to be safe, effective and well-liked by patients.

Further, some states require physicians to follow the protocol described in the FDA-approved labeling of mifepristone that was, up until recently, out of date and not consistent with published evidence. For every other drug, doctors are allowed to use medications according to published evidence, even if this differs from protocols described in a drug’s label. This so-called off-label use of medications is quite common, especially in obstetrics and pediatrics.

The restrictive abortion law in Texas, known as H.B. 2, forced physicians to follow the outdated protocol, which required more visits, increased costs and limited who was eligible for the method, leading to a 70 percent decline in medication abortion. A study in Ohio, where such a law is also on the books, found that the outdated protocol led to more women needing additional treatment with medications or suction abortion to complete the procedure.

In March of this year, the FDA approved an updated label for mifepristone, which has allowed physicians in Ohio and Texas, as well as North Dakota, to once again offer medication abortion according to evidence-based protocols. The fact that the FDA process of updating the label occurred without political interference is also cause for celebration.

But beyond state-imposed roadblocks, though, there are restrictions on how mifepristone can be dispensed. When the drug was approved back in 2000, there were concerns about its safety profile that led to certain restrictions in how it could be distributed. For example, mifepristone can only be dispensed at a clinic, doctor's office or hospital, and it cannot be obtained at a pharmacy with a prescription. A doctor who wants to provide mifepristone must enter into a relationship with the drug's distributor and self-certify that she or he is competent to do certain things such as determine how far along the pregnancy is, which most physicians who treat reproductive-aged women do on a weekly basis.

There is no doubt that these restrictions on where and how the drug is dispensed restrict access. It is a hassle to stock medications in one's clinic, and in this era of violence against abortion providers, it is understandable that few physicians want to take the extra step of registering themselves with the company that distributes mifepristone and risk being identified.

It is time for these dispensing restrictions on mifepristone to be removed. After 16 years of experience with medication abortion, it is clear that this option is very safe. A well-designed study of over 11,000 medication abortions in California found that less than one-third of 1 percent of patients had a complication requiring treatment in a hospital. In fact, even the FDA has recognized how safe the drug is by limiting the types of complications that need to be reported to them. Prior to March 2016, doctors had to send a report on any patient with a severe adverse event, such as blood transfusion, but now only deaths need to be reported.

Luckily, death after medication abortion is exceedingly rare. According to the drug's manufacturer, there have been only 14 deaths related to the use of mifepristone, among about 2.8 million women in the U.S. who have used the method. By way of comparison, in the first 10 years after erectile dysfunction drugs like Viagra were approved, more than 2,000 men died while using the products. Of course, many more men use these drugs compared to women who have had a medication abortion – and these men are more likely to be older and have underlying medical conditions. But it is interesting that these medications for erectile dysfunction are easily available in pharmacies, where they are not subject to the added level of scrutiny paid to mifepristone.

Sixteen years on, abortion politics and stigma are putting the brakes on access to a safe and effective technology that women want. It is time for the FDA to remove the restrictions on how mifepristone is dispensed since these regulations are not based on scientific facts. Similarly, laws must be challenged in states that are unnecessarily limiting who can provide medication abortion or how it can be provided. After the recent U.S. Supreme Court ruling in Whole Woman's Health v. Hellerstedt, courts are likely to be receptive to overturning laws that restrict access to abortion when such laws confer no health benefit. After almost two decades of waiting, American women deserve to see the mifepristone revolution they were promised at the turn of the century.