New reports confirm the safety of the Mifiprex pill, a hormonal pill used for medical abortions, which could sway legislators on their vote regarding Senate Bill 320.
Senate Bill 320, which is scheduled to go to a vote in the State Assembly this year, will determine whether Mifeprex will be required at all California public university Student Health centers, including UC Santa Barbara.
The Government Accountability Office (GAO) was asked to review the FDA’s report in response to concerns raised to Congress about the safety of the drug in light of the 2016 changes, according to Marcia Crosse, a director in the GAO’s Health Care Team.
The GAO is a department of the U.S. Congress that oversees decisions made by the executive branch, which includes the FDA, Crosse explained.
The GAO began their research of the report in April of 2017.
The Nexus previously reported that the bill was approved by the California Senate in January. If the bill is approved by the Assembly and signed by Governor Jerry Brown, all California public universities will offer the pills by Jan. 1, 2022.
Support for this bill comes largely from the Women’s Foundation and the Tara Health Foundation that, along with other anonymous backers, are fully funding the implementation of SB 320 into public universities, according to a press release by the Tara Health Foundation and the Women’s Foundation.
“Once a student has decided to end a pregnancy, they shouldn’t be forced to go off campus to see a provider they don’t know,” Surina Khan, CEO of the Women’s Foundation of California, said in a press release.
The National Academy of Science, Engineering and Medicine (NASEM), a non-partisan council, also released a report on March 16 that confirmed that the Mifeprex pill is safe and effective.
In a study published by NASEM, 96.7 percent of abortions performed by Mifeprex before 63 days of gestation were effective, and 93.1 percent of abortions performed between 64 to 70 days after gestation were effective.
“[The study] confirms what research has shown for decades—that medication abortion can be safely and effectively provided in a variety of settings,” said Senator Connie Leyva, the author of SB-320. “I urge my colleagues in the Assembly to consider these findings and swiftly pass SB 320.”
These changes, which were implemented in 2016, include a change in the dosing regimen from 600 mg, approved in 2000, to 200 mg. The gestational time limit changed from 49 days to 70 days, according to the report by the FDA that was published on March 29, 2016.
In accordance with the new label, the drug can also be administered by a health care provider rather than a physician, which the old label required. Post-treatment includes an assessment of the patient 7-14 days after the drug is taken, rather than a formal examination conducted by a physician, according to an article published by the Pharmacy Times.
The waiting period to take Misoprostol, the medication taken after Mireprex, changed from 72 hours to 24-48 hours. The dosage of Misoprostol was also changed from 2 tablets (400 mcg) to 4 tablets (800 mcg).
“[People] argued that the FDA were missing instances [in their review of the drug] where patients might have died because they were not using one of the [proper] monitoring systems that monitor the safety of drugs,” Crosse said.
The Sentinel System is the monitoring system used by the FDA to determine the safety of medicine by analyzing health information made available by physicians online, according to the FDA website.
After an investigation of the FDA’s approval of changes, the GAO found that the attacks by the critics against the proper use of the Sentinel System were invalid because the Sentinel System applies only to drugs distributed through pharmacies.
“MifePrex is not distributed through pharmacies so information on it would not be available in the Sentinel System to allow it to track safety concerns,” Crosse said.
Mifeprex does have another mechanism to track its safety concerns, and Crosse confirmed that Mifeprex has a low rate of serious medical events that occurred as a result of women taking the drug.
A version of this article appeared on p.4 of the April 5 print edition of the Daily Nexus.
Correction: An original version of this article stated that SB 320 will allow all public universities to provide the abortion pill. SB 320 will require them to provide the abortion pill.