Bicameral Congressional Letter Demands Transparency from FDA
Yesterday 75 members of Congress, led by Rep. Chris Smith of New Jersey and Sen. James Lankford of Oklahoma, sent a letter to the Commissioner of the Food and Drug Administration demanding answers to questions about the FDA’s surprise approval of relaxed protocols for the distribution of the abortion-inducing drug regimen known as Mifeprex. The changes, announced on March 30, significantly increase the duration of pregnancy at which the drug regimen may be administered, raising it from 49 days (7 weeks) from the last menstrual period (LMP) to 70 days (10 weeks) post-LMP.
Previous medication guidance from the FDA (still online here) underscored that the seven-weeks LMP limitation (five weeks post fertilization) was imposed due to safety considerations that emerged during the period when the drug’s safety was studied among women age 18-45 (younger teenagers were not included in these studies). The FDA medication guide for the regimen notes that between two and seven of every 100 women taking the drug will need a surgical abortion to complete the procedure and past research has noted the sharp increase in incomplete medication abortions as the length of the pregnancy proceeds. The following table, taken from the Population Council trial of Mifeprex in the late 1990s, shows a near tripling of the overall failure rate from medication abortions performed before 49 days and those performed 63 days (one week short of the new upper limit approved by FDA). The rates of incomplete abortion and need for other medical intervention (due to hemorrhaging) also rose sharply.
| Days’ gestation | ≤ 49 | 50–56 | 57–63 | all (≤ 63) |
| Number | 827 | 678 | 510 | 2015 |
| Mifepristone alone | 4.8% | 1.8% | 0.8% | 2.8% |
| Total success | 92.1% | 83.0%* | 77.5%† | 85.4% |
| Ongoing pregnancy | 1.0% | 3.7% | 9.0% | 3.9% |
| Incomplete abortion | 4.7% | 7.5% | 7.1% | 6.3% |
| Medical intervention‡ | 1.6% | 3.8% | 4.1% | 3.0% |
| Patient request | 0.6% | 1.9% | 2.4% | 1.5% |
| Total failure | 7.9% | 17.0% | 22.5% | 14.6% |
*Statistically different (p < 0.05) than group ≤ 49 days’ gestation.
†Statistically different (p < 0.05) than group ≤ 49 days’ and 50–56 days’ gestation.
‡Hemorrhage.
In light of this and other historical data undergirding the previous policy, and the unusual circumstances under which Mifeprex is licensed, manufactured, distributed and monitored today, the members of Congress writing to the FDA demanded access and transparency. The text of the letter, linked here, requests the following documents, inter alia: an update to the post-marketing adverse event summary for the Mifeprex regimen, which has not been updated in five full years; a list of documents submitted by the drug manufacturer, Danco, with headquarters located in the Cayman Islands, including but not limited to its applications to the FDA to loosen the protocol of administration; and copies of all safety studies and notes concerning them obtained or developed by the FDA as it made the March 30 decision. The members of Congress demanded that FDA provide replies no later than May 20, 2016 and that, if all documents are not assembled by that date, whatever documents have been accumulated be forwarded without further delay.
Given the generally sorry state of U.S. abortion reporting, particularly as regards medical harms to women, Congressional interest in this potentially far-reaching policy change by the FDA should remain a high priority.
Charles A. Donovan is president of the Charlotte Lozier Institute.
