As a Texas federal judge’s decision threatens to restrict nationwide access to a widely used abortion pill, its maker says US regulators have ways to let the medication stay on the market while the case works its way through the courts.
(Bloomberg) — As a Texas federal judge’s decision threatens to restrict nationwide access to a widely used abortion pill, its maker says US regulators have ways to let the medication stay on the market while the case works its way through the courts.
The Food and Drug Administration’s more than two-decades-old approval of the abortion pill is in question after a conservative judge sided with those who say the government didn’t approve the drug through the proper channels. That ruling is set to take effect Friday but the US government has sought an emergency order to block the ruling, setting off what could end up being weeks or even months of wrangling over whether it’s legal to distribute the abortion pill in the US.
So far, online pharmacies that distribute the pill have said it’s business as usual. The drug’s primary maker, Danco Laboratories, said that status could continue if the FDA decides not to use its enforcement discretion against those selling it. The FDA, which regulates drug supply in the US, has discretion over whether or not to penalize doctors, pharmacies or drugmaker if a treatment is being given in violation of its rules.
“Enforcement discretion is definitely top of mind, because that really will set the tone or inform what providers can do and what we can do, especially in this interim period,” said Abby Long, a spokesperson for Danco.
The FDA often uses enforcement discretion regarding use of unapproved drugs, said Rachel Rebouché, dean of the Temple University Beasley School of Law. For example, vitamins or supplements, are sold all the time in the US without FDA approval. The agency can choose not to take action against those supplements or vitamins if they’re not considered risky or harmful, she said.
“There could be something very similar here, given that the mifepristone has been approved for 23 years, it’s widely available on the market, and has a very good safety record,” she said. “There’s not a lot of reason for the FDA to take action.”
Conflicting Ruling
The Texas decision was followed almost immediately by a conflicting ruling from a federal judge in Yakima, Washington who told the government to preserve access to the pill, creating a wave of uncertainty and confusion. Drugmakers and abortion pill providers are waiting to see how the FDA will go about enforcing the contradictory rulings.
Long said Danco has been communicating regularly with the FDA, but the company is still waiting on official word from the agency on what it will do if the drug’s approval is deemed invalid by the lawsuit.
If the agency decides not to penalize practitioners, pharmacies or companies providing the abortion pill, “it has to be communicated to both us and our distributor, or distributors as a whole, so that they know that it’s acceptable for them to continue to provide” the drug, Long said.
The FDA said Friday that the agency stands behind its determination that mifepristone is safe and effective under its approved conditions for use. The FDA didn’t have further comment on Tuesday when asked about its plans in the event the drug is pulled.
The unprecedented nature of the Texas decision and the uncertainty surrounding access to the drug has prompted some states to take steps to build their own supplies of the pill. On Monday Massachusetts announced that it would stockpile 15,000 doses of the drug. It followed Washington state’s decision to purchase of a three-year supply of the drug last week.
Awaiting Clarity
Other states, such as California and New York, are stockpiling the drug misoprostol, which is not affected by the Texas ruling and has other uses besides abortions. It and can be given on its own to terminate a pregnancy, but is more effective in combination with mifepristone.
Danco’s Long said individual abortion pill providers are also ordering more mifepristone than usual.
“The feeling is that if they have the drug there in their clinic, then they’re okay,” Long said.
Amid the confusion, online abortion pill pharmacies are continuing to sell the pill, while awaiting clarity.
“We will continue to mail the gold standard for medication abortion, mifepristone and misoprostol, for as long as possible,” Jessica Nouhavandi, co-founder of HoneyBee, said in an emailed statement on Tuesday. “We are prepared to switch to misoprostol-only protocols if necessary, but we will continue to dispense any mifepristone we have in stock,” Nouhavandi said.
Telehealth abortion clinic Hey Jane said it’s confident that the Texas ruling won’t affect its ability to provide both mifepristone and misoprostol. The company plans to continue to monitor both lawsuits as they progress and provide updates to patients as needed, co-founder and Chief Executive Officer Kiki Freedman said.
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