Indiana Senate Bill 72

Since the time Pharmer was first informed of current Indiana legislation to regulate the use of abortion drugs,  there have been significant changes to the bill.

Of special concern is that no longer a  requirement to report adverse events associated with abortion drug use.
Existing  forms and services can be used  for such reporting with respect to drugs and medical devices,  for example:
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf

Adverse events associated with or related to childbirth are reportable as such to  include the whole period of pregnancy, childbirth and the year after delivery, at the recommendation of the ACOG.
The non reporting of abortion related adverse events and deaths, combined with the more readily reported pregnancy related or associated deaths has led to false statistics comparing the relative risk of childbirth and abortion.
Senate Bill 72 is now structured in such a way as to facilitate a means to convince women  that abortion is safer than childbirth.   The lack of requirement for reporting abortion drug adverse events  serves to worsen the current  skewing and misrepresentation of facts, which denies patients the opportunity of giving informed consent.

Useful parts of the bill worth noting:  The definition of abortion inducing drug includes “off-label use of drugs known to have abortion inducing properties if the drug is prescribed with the intent of causing an abortion”.  (Ch.3 sec.1a)
The bill also requires that the abortionist  “follows the drug label protocol for the abortion producing drug. (Ch3. sec 3a-2)
Expect a firestorm from planned parenthood which utilizes mifepristone, RU-486, in an off label manner by using less of the drug  (a single 200mg tab) than recommended on the label, (three 200mg tablets)  and by using it up to, or at 63 days gestation instead of 49 days.
According to the Mifeprex label, U.S.,  three x 200mg tabs are to be administered in a single dose, and the patient returns to the clinic in 2 days to take 2 tabs (400mcg) of misoprostil, to expel the human embryo or fetus.   Planned Parenthood of Indiana is sending the patients home with four tablets (800mcg) according to their own info.

From Drs Gary and Harrison at Medscape:  “The US clinical trial demonstrated a failure rate of 8% at 49 days or less from the last menstrual period (LMP), increasing to 17% at 50-56 days from the LMP, and further increasing to a 23% failure at 57-63 days from the LMP, as established by sonographic criteria………One serious concern raised by this review of AERs is the suggested fetal malformation rate of at least 23% following mifepristone failures that resulted in continuation of a live pregnancy.”

Annals of Pharmacotherapy analysis of mifepristone adverse events reported to FDA 2000-2004.