July 15 P&P Quick Takes: Senate bills for antibiotic de-linkage, germline editing; plus site inspections and PK guidance

Senators co-sponsor antibiotic de-linkage bill
Fourteen Democratic senators introduced legislation, the Affordable Medications Act (S. 1801), that includes provisions to set aside $2 billion for an Antibiotics Innovation Incentive Fund that would grant up to three awards for new antibiotic drugs over 10 years. In exchange for the market entry awards, drug developers would relinquish patent and market exclusivity rights.

Lawmakers call for consensus on germline editing
Sens. Dianne Feinstein (D-Calif.), Marco Rubio (R-Fla.) and Jack Reed (D-R.I.) introduced a resolution Monday encouraging the secretary of state to work with the United Nations and the World Health Organization to create an international consensus on "the limits of ethical clinical use of genome-edited human embryos." The resolution supports the international commission formed in May by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences and the Royal Society of the U.K. to create a framework for assessing potential clinical applications of human germline genome editing. The resolution also directly opposed the work of Chinese scientist Jiankui He, who used CRISPR-based gene editing in human embryos that led to the birth of two babies (see "Launch of Germline Editing Commission")...