The Obama Administration should keep politics out of FDA approvals.
FDCA requires that the HHS Secretary "shall" approve a drug proven "safe and effective" for the target population. The drug company must submit multiple adequate and well designed studies.
Political concerns is not one of the reasons the Secretary may deny a drug. Where FDA's scientists find a drug safe and effective, the Secretary should defer.
Politics should not be part of the drug approval process. It oversteps the Executive's authority, it increases regulatory uncertainty, and it reduces incentives to invest in American jobs.