Enforce the FDA approval process for new drugs consistent with Human Rights Protections of The Common Rule.

We need to stop the use of dangerous off-label prescription drugs. The Food and Drug Administration needs to increase the enforcement of regulations to protect the public health. Off-Label use of prescription drugs is the use of a drug that is not proven to the FDA to be safe or effective. Without clinical research evidence of a drug's safety or effectiveness, the use of these medications is actually scientific experimentation on the patients without human rights protections under the Common Rule. Off-Label Promotion and use of prescription drugs needs to be curtailed. Off-Label Promotion, misbranding and direct market detailing to doctors, encourages the use of dangerous drugs on persons with disabilities, the elderly, and other vulnerable populations. 21 U.S.C. § 393(b)