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FDA’s Own Rules Hamper Access to Abortion Pill Biden Touts (1)

June 30, 2022, 7:29 PM

The Biden administration says it’s taking steps to increase access to medication abortion in response to the Supreme Court decision to reverse Roe v. Wade, but some of the administration’s own policies stand in the way of people trying to get the drug.

Mifepristone, the drug known as the abortion pill, has been approved in the US for more than 20 years and has been shown to be safer than commonly used drugs like Tylenol. But federal regulations strictly limit the circumstances under which patients can get it. While the administration last year loosened some rules on prescribers, it added new hurdles for pharmacies to dispense abortion pills. Several states have regulations on top of that, limiting who can prescribe it or requiring people to attend in-person doctor’s appointments to get the pill.

The White House quickly pointed to the abortion pill as an answer to the post-Roe world in which some 33 million women could lose access to procedures in their home states. President Joe Biden ordered his health officials “to identify all ways to ensure that mifepristone is as widely accessible as possible,” according to a White House statement.

Health and Human Services Secretary Xavier Becerra said the administration was taking steps to increase access without sharing specifics. It’s unclear what the administration will be able to do. Becerra, whose department oversees the Food and Drug Administration, declined to say whether he would direct the agency to loosen restrictions on the abortion pill.

“Medication abortion -- those treatments that FDA has signed off on as safe and effective -- are available to be prescribed,” Becerra said at a news conference this week. “Under what conditions? Stay tuned.”

The FDA has been under pressure for years from medical and advocacy groups to loosen restrictions on the abortion pill. Leading medical bodies have called the rules unnecessary. In response to a lawsuit, the agency amended its policies and in December permanently allowed the abortion pill to be dispensed by mail but left other restrictions in place.

It also added a new restriction: any pharmacy that wanted to dispense the abortion pill had to be certified. That created another bureaucratic hurdle that continues to limit the pill’s reach.

“These pills have been around for decades now but they’ve been overregulated,” said Elisa Wells, cofounder of Plan C, an organization that helps women access abortion pills online. She said the FDA’s restrictions should have been lifted “decades ago, so these safe and effective pills could be made available through pharmacies, just like any other pills.”

Read More: The abortion pill is safer than Tylenol and almost impossible to get.

Strict Regulations

Despite its safety record, mifepristone is only available to patients under a risk evaluation and mitigation strategy, or REMS, that requires education and monitoring for doctors and patients. Such policies are normally reserved for drugs with exceptionally rare and dangerous side effects.

The American College of Obstetricians and Gynecologists opposes the restrictions on mifepristone, saying that “decades of evidence and the consensus of the medical community underscore” the drug’s safety, according to the professional group’s website. The American Medical Association has also repeatedly called for the FDA to remove the safety requirements.

Late last year, the FDA said that patients need only a virtual doctor visit to get the drug, permanently lifting a requirement for in-person consults that had been relaxed during the pandemic. But with that, the agency added a new requirement for the manufacturers -- Danco Laboratories LLC and GenBioPro Inc. -- to certify pharmacies before they can dispense the medication.

Danco said in an email Tuesday that it has submitted a tentative pharmacy certification plan to the FDA, which must approve the plan before it takes effect. The company added the FDA’s timeline is “uncertain,” and that it expects “there will be several discussions between us and the FDA before finalization.”

GenBioPro didn’t respond to requests for comment.

The FDA didn’t address questions this week about when pharmacies would be certified to dispense abortion pills. The FDA said the certification rules for pharmacies “will ensure that pharmacies are aware of and agree to follow applicable REMS requirements, and ensure that mifepristone is only dispensed with a written prescription from certified prescribers,” in an email response to questions from Bloomberg News in May.

Mississippi Case

It’s unclear how state abortion bans now taking effect following the Supreme Court’s reversal of federal abortion rights will affect the availability of these pills. The three liberal justices noted the uncertainty in their dissenting opinion:

“Can a State interfere with the mailing of drugs used for medication abortions? The Constitution protects travel and speech and interstate commerce, so today’s ruling will give rise to a host of new constitutional questions,” they wrote.

Mississippi has put restrictions on prescribing mifepristone that are stricter than the federal rules, including requiring that a licensed physician prescribe it in person. GenBioPro has challenged the state’s policy in a lawsuit. The company argues that the FDA’s regulations for dispensing and prescribing the abortion pill preempt state rules. Mississippi has moved to dismiss the lawsuit.

Read More: Biden has few options to enact abortion moves Democrats demand.

Becerra didn’t respond to questions Tuesday on whether the Biden administration plans to support GenBioPro’s challenge. Constitutional and FDA policy attorneys have said that the company’s argument could serve as a basis for future lawsuits against state mifepristone restrictions.

Attorney General Merrick Garland, in his statement condemning the Supreme Court decision, said states can’t ban the drug because they disagree with the FDA’s assessment of it.

Pharmacy Questions

Some of the largest US pharmacy chains said it’s too early to say whether they plan to dispense the medication. A spokesperson for CVS Health Corp. said “it is premature for us to comment further at this time on the certification program” in an email Friday.

Representatives for large US pharmacy operators -- including Walgreens Boots Alliance Inc., Rite Aid Corp, Walmart Inc. and Kroger Co. -- either declined to comment or didn’t respond to questions about whether they planned to dispense abortion pills. UnitedHealth Group Inc. and Cigna Corp., health giants that operate large mail-order pharmacies, didn’t respond to questions about whether they intended to make the pills available.

No major mail-order pharmacies or pharmacy benefit plans surveyed by Mercer are distributing mifepristone, according to Raymond Brown, a partner in the employee benefits consulting firm. “They all have consistently indicated their mail orders are not distributing this product, or shipping this product, even if it’s covered at this time,” Brown said Thursday in a webinar. “They’re still working through the certification process.”

(Updates with Mercer comments in the last paragraph)

--With assistance from John Tozzi and Sara Hansard.

To contact the reporters on this story:
Shira Stein in Arlington at sstein51@bloomberg.net;
Fiona Rutherford in New York at frutherford@bloomberg.net;
Celine Castronuovo in Arlington at ccastronuovo@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

John Lauerman, John Tozzi

© 2022 Bloomberg L.P. All rights reserved. Used with permission.