program was instituted. Of these cases, the majority underwent abortions—either spontaneous or elective—with a handful of children reported to be born with typical isotretinoin-induced birth defects. When surveyed, many pregnant people reported that their physicians had attempted to downplay the risks of isotretinoin or violated the standards in other ways, such as failing to inform them of the need to use two forms of birth control or allowing them to substitute a single, less-accurate urine pregnancy test conducted in the doctor's office for the two laboratory-conducted blood pregnancy tests mandated by SMART. The FDA also concluded that, considering the voluntary nature of the reporting program and lack of mandatory record-keeping, the actual number of pregnant people affected was likely far higher than the reported number. Mandatory reporting and verification The report led to SMART being dismissed as "a total failure", with the FDA quickly moving to halt the downward slide with a stricter mandatory registry system to document and verify all isotretinoin prescriptions written or dispensed in the United States. This was a feature originally included in the plan for SMART recommended by the original FDA advisory panel and wholeheartedly endorsed by the pharmaceutical manufacturers, but removed due to concerns that political opposition from lobbying groups would delay the program's implementation. Although eventually resolved, the older concerns proved valid in 2003 when the launch of iPLEDGE was held up for three years while objections from women's rights, patient's rights, physician's rights and pro-choice lobbyists were debated in committee. The iPLEDGE program was put into place a group formed by the companies that manufactured the drug at the time – Roche, Mylan, Barr, and Ranbaxy – called the Isotretinoin Products Manufacturing Group (IPMG); they are responsible for iPLEDGE and they hired Covance to manage it. The program launched on March 1, 2006, at the beginning of the annual meeting of the American Academy of Dermatology. In the U.S., around 2000 people became pregnant while taking the drug between 1982 and 2000, with most pregnancies ending in abortion or miscarriage. About 160 babies with birth defects were born. In 2011, after the FDA put the more strict iPLEDGE program in place, 155 pregnancies occurred among 129,544 patients taking isotrentinoin (0.12%) who have the capacity to become pregnant. Criticisms Criticisms of the iPLEDGE program include the following: Difficulty of compliance When the Program launched in March 2006, there were many complaints about how