Members of House and Senate ask for documents behind FDA change in FDA protocol

By Dave Andrusko

Rep. Chris Smith (R-NJ)

Rep. Chris Smith (R-NJ)

If you click here, you can read the entire letter sent by Rep. Chris Smith (R-NJ) and Senator James Lankford (R-OK), joined by 73 of their colleagues, to Dr. Robert M. Califf, M.D., the FDA’s Commissioner, “requesting information about the agency’s recent decision to change its policies regarding the abortion drug mifepristone.”

The letter is respectful and courteous, but asks for data that was not forthcoming last month when the FDA relaxed safety standards and modified the protocol for mifepristone/misoprostol chemical abortions that had been in place since September of 2000.

This was a great coup for the Abortion Industry, particularly Planned Parenthood. The FDA was retroactively giving its seal of approval to various important changes the Abortion Industry made unilaterally.

As Dr. Randall K. O’Bannon, NRL’s director of education, summarized

The FDA, responding to a request by the U.S. distributor of the drug, has modified dosages –more of the cheaper misoprostol, less of the more expensive mifepristone– changed the administration, reduced the number of visits –eliminating the second visit to the abortionist altogether– expanded the prescriber pool, and extended the time in pregnancy where the drugs may be used from 7 weeks to 10 weeks. Though applauded by the abortion industry, the documentation demonstrating the impact on women’s safety has not been made publicly available.

Sen. James Lankford (R-OK)

Sen. James Lankford (R-OK)

Among the information the congressmen and senators asked for was:

*A thoroughly updated “Postmarketing Adverse Events Summary” including any reported deaths associated with mifepristone through December 2015. The current available data on Adverse Events has only been updated through April 2011.

*A copy of all documents, studies and other evidence used to assess the safety and efficacy of the Mifeprex (mifepristone) changes announced on March 30, 2016.

The letter asks for a response by May 20.

It will be fascinating to see how this change came about, especially in light of the fact that of four years ago [!]the deaths of 14 women had been associated with the use of RU-486 and that there had been 2,209 “Adverse Events.”

Adverse events is a blanket term that covers everything from the need for blood transfusions to endometritis, pelvic inflammatory disease, and pelvic infections with sepsis (“a serious systemic infection that has spread beyond the reproductive organs,” according to the FDA).