GAO investigation calls FDA review of abortion pill ‘unusual’ News
GAO investigation calls FDA review of abortion pill ‘unusual’

[JURIST] In a report [PDF text; summary] released Monday, the US Governmental Accountability Office (GAO) [official website] characterized the Federal Drug Administration's review of the birth control drug Plan B [product website; FDA backgrounder] for over-the-counter sale as "unusual" in procedure. The GAO report alleges that FDA management was more involved in Plan B approval than usual; that the decision not to approve the drug may have been made before the review was completed; and that the reasoning for not switching the prescription drug to an over-the-counter product was "novel and did not follow the FDA's traditional practices." An FDA spokesperson denied the allegations of improper conduct, saying that "the report mischaracterizes facts and does not appear to take into consideration the input provided by the FDA." In August, the agency indefinitely postponed a decision [FDA news release] on whether to approve the drug for over-the-counter sale, prompting an FDA official to resign in protest [JURIST report]; the official later accused the FDA of political maneuvering [JURIST report] during the approval process. A bipartisan group of US representatives introduced a bill [JURIST report] earlier this month that would automatically approve Plan B for over-the-counter sale 30 days after bill approval if the FDA fails to make a decision on the drug by that time. Reuters has more.

THIS DAY @ LAW

Pope Urban II sparks First Crusade

Pope Urban II threw his support behind what would become the First Crusade on November 27, 1095 during the Council of Clairmont. The Pope urged the council's participants to render aid to the Byzantine Empire, which was being attacked by the Seljuks. Pope Urban called for a wide coalition of rich and poor to combat the threat, which eventually resulted in the conquest of much of the Muslim-controlled Levant by the Crusaders and the establishment of the Crusader States. Read Pope Urban's address.  

Catholic Code of Canon Law revised

On November 27, 1983, the revised Code of Canon Law of the Roman Catholic Church went into effect. Learn more about the history of Canon Law from Professor Kenneth Pennington of the Catholic University of America's Columbus School of Law.

Alfred Nobel creates Nobel Prize in his will

On November 27, 1895, Alfred Nobel signed his will, creating the Nobel Prize. Learn more about the history of the Nobel Prize and the Nobel Commission.