Total ban on background music is unnecessary, agency says in denying KEI’s petition. FDA points to new ‘major statement’ rule and its previous letters objecting to a sponsor’s use of music in ads and says it will continue case by case analysis of ‘all of the elements’ in an ad.

Cooper announced a plan to buy Cook’s reproductive health business in February. The deal would have been worth $675m up front and $200m in four annual installments. The US FTC determined the deal would have impaired competition in the reproductive health market.

Proposed rule issued in March 2010 requires ‘major statement’ on a drug’s side effects in ‘a clear, conspicuous, and neutral manner’ for TV and radio ads. Bill would mandate a final rule within six months.

Office of Prescription Drug Promotion issued six enforcement letters and launched three research projects in 2021. There were more internal changes as the office switched to electronic submissions of promotional materials and went through year-end reorganization.