Lawmakers Urged To Revisit Exclusivity, Packaging In OTC User Draft

Lawmakers may need to tweak provisions in the recently released over-the-counter monograph reform discussion draft that give FDA authority to issue administrative orders on packaging requirements for OTC drugs and to award two years of exclusivity to OTC drug manufacturers. FDA and stakeholders pointed to both provisions as issues that require a second look from Congress during the House Energy & Commerce health subcommittee's Wednesday (Sept. 13) hearing on the bill. The bill, released Monday (Sept. 11), would reform the...