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In 2000, a new abortion method became available in America: an oral drug called mifepristone.
Previously, early in pregnancy, the procedure often consisted of emptying the uterus by suction. But taken with another drug called misoprostol, mifepristone can terminate a pregnancy within the first 10 weeks without requiring any clinical procedures. Patients can follow the process in any context, with whom they want – or alone.
For these reasons and others, medical abortion has gained tremendous popularity since its introduction. In 2014, it accounted for 45% of all abortions before nine weeks.
Despite its popularity, only one company has sold the drug on the US market in the last 19 years. This week, it has changed: the company GenBioPro puts on the market the first generic version of the drug. She believes that its release could help reduce costs for patients and ensure that doctors have a reliable drug supply. "It's always risky to have one product on the market," said Mary Fjerstad, director of medical affairs at GenBioPro, Vox.
But even with a generic available for the first time, many barriers to medical abortion remain. Doctors say that drugs are extremely safe, but they are extremely limited: patients need to get them at the doctor rather than at a pharmacy, and doctors have to go through a special process to get a certification to provide them. As a result, many doctors do not offer mifepristone and patients may have difficulty getting it.
GenBioPro considers that its mission is to promote "reproductive autonomy," said its president, Evan Masingill, to Vox. And experts say that a generic option will help patients to some extent. But the history of mifepristone concerns a lot more than pills and supply chains; these are state and federal restrictions on abortion, even though doctors say they are not necessary for the health of patients.
A generic option could reduce costs and prevent shortages
Medical abortion works as follows: a person takes a single oral dose of mifepristone, which prevents the pregnancy from progressing. Until 48 hours later, the patient takes misoprostol, which causes contraction of the uterus, essentially inducing a miscarriage.
Patients usually have bleeding and cramps, as in any miscarriage, but the process is very safe and very effective: complications occur in less than 1% of cases, and drugs can end a pregnancy 95% of the time. time.
Mifepristone is traditionally available in the United States from a single company, Danco Laboratories, which sells it under the brand name Mifeprex (mifepristone is also sometimes referred to as RU-486, a European name). But with the GenBioPro pill, there will now be a second option.
"When we started to analyze the landscape and determine where we could have the most impact, this product came down to us in particular," Masingill said. They sought FDA approval, received it in April, and officially launched the drug on Tuesday.
According to GenBioPro, the introduction of a generic will lead to a more reliable supply of the drug. Fjerstad pointed to recent shortages of drugs like lidocaine anesthetic, which have forced some doctors to cancel surgeries and other treatments. Although such shortages have not been reported for Mifeprex, GenBioPro believes they may be more likely if there is only one company selling mifepristone. "There is only one product on the market, if there is a problem at all in the supply chain," said Fjerstad, "that's creates a huge problem for clinics that need this drug. "
Then there is the question of cost. Mifeprex currently costs about $ 90 per pill to providers, said Dr. Karen Meckstroth, clinical professor at the University of California at San Francisco and medical director of a clinic offering early abortions. Danco does not make public the cost of his drug.
GenBioPro does not say exactly what the cost of its generic drug will be, but the company expects the launch of its product to lower prices through competition. "Whenever a generic comes on the market, the price is usually a little cheaper," Fjerstad said.
Overall, "having a generic on the market is extremely important to us as suppliers," said Dr. DeShawn Taylor, GenBioPro's senior medical director. "We all know and love someone who has had an abortion and so we want to be able to expand access to an extremely safe and effective form of abortion, which is a means approved by the FDA to put end a pregnancy. "
But many obstacles to access remain
Doctors and experts outside GenBioPro say the introduction of a generic drug is important, but it's unclear how much this will make a difference for patients.
"Having different manufacturers definitely helps in terms of price competition and increased availability," said Alina Salganicoff, Senior Vice President and Director of Women's Health Policy at the Kaiser Family Foundation. "But in the end, will the drugs be more accessible to women, will they become more affordable, remain an open question."
One of the reasons for the uncertainty is that the cost of the drug itself is only part of the cost of a medical abortion. In 2014, patients paid an average of $ 538, compared with $ 508 for a 10-week clinic abortion (many insurance plans do not cover abortion and most patients pay out of pocket).
In addition to the pill itself, patients usually have to pay the costs of doctor visits and laboratory work. Meanwhile, state laws may impose additional costs. For example, some states require patients to go to a clinic for pre-abortion counseling, and then have a waiting period before getting the drugs. Others require an ultrasound, an extra expense, although doctors say that this is not always necessary in case of early abortion.
"Anything that reduces costs eliminates some financial hurdles," Salganicoff said. But "if women still have to make multiple visits and have sonograms," she added, "it also costs money."
One of the main barriers to obtaining mifepristone is related to how it is administered: the drug is subject to the Food and Drug Administration's Risk and Remediation Strategy (REMS). Under the REMS, the drug can not be distributed in a pharmacy like other drugs (including its counterpart, misoprostol). It can only be provided by a physician or other clinician who has undergone a special certification process.
This process deters many doctors. "People are afraid of being on a list," said Meckstroth, referring to concerns about the stigma and harassment that abortion providers may experience.
You do not have to be an OB-GYN or a surgical abortion provider to get a certification, said Meckstroth, which means that in theory, patients could get the medication from their primary care physician. But because of the onerous certification process, few primary care clinicians offer the drug. In fact, when the Meckstroth team recently looked for primary care clinics or other general health centers in California offering medical abortions outside of abortion clinics, it found only one – a where she is the medical director.
Abortion advocates agree that the FDA's requirements could limit the impact of the GenBioPro pill. "Although the generic form of mifepristone is important and long overdue, the real barrier to access to medical abortion, especially for people living in rural and medically underserviced areas, is unnecessary restrictions. imposed by the FDA on how mifepristone is administered, "said June Gupta, medical standards director of the Planned Parenthood Federation of America, in a statement to Vox.
Anti-abortion groups opposed the introduction of mifepristone in the United States and said the current FDA guidelines were too lenient and insufficient to protect women's health. But reproductive health groups and many doctors say the opposite is true.
A REMS is for drugs with serious safety concerns, and experts have long argued that it is not necessary to take mifepristone, which is as safe as many prescription drugs available in pharmacies. In fact, Jane E. Henney, Commissioner of the FDA at the initial approval of mifepristone in 2000, wrote in the New England Journal of Medicine earlier this year that the REMS should be re-evaluated.
"After nearly two decades of effective use, additional research and a comprehensive review by the National Academies of Science, Engineering and Medicine (NASEM)," she wrote with her co-author, Helene D. Gayle, to demonstrate that mifepristone is extremely safe and effective, we believe that distribution restrictions may no longer be appropriate. "
The FDA has the power to modify or delete the REMS without Congressional intervention, but it has not shown any signs to that effect. In the meantime, doctors may not want to stock mifepristone, whether it is generic or not.
In press releases announcing the introduction of the drug, GenBioPro expresses its commitment to access to abortion: "We support the community of providers, patients and advocates who work for universal access to universal health care. affordable and quality reproductive health ".
However, a pharmaceutical company can only do much to challenge a system of laws and regulations that makes medical abortion more difficult to obtain than other drugs of comparable safety. And for now, the story of mifepristone in America is as much about what has not changed as about what has changed.
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