Food and Drug Administration Safety and Innovation Act

From Wikipedia, the free encyclopedia
Jump to: navigation, search

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.

Synthetic Drug Abuse Prevention[edit]

The law also contains the Synthetic Drug Abuse Prevention Act of 2012. The legislation bans synthetic compounds commonly found in synthetic marijuana ("K2"[1] or "Spice"), synthetic stimulants ("bath salts"[2]), and hallucinogens, by placing them under Schedule I of the Controlled Substances Act.

Generating Antibiotic Incentives Now[edit]

Under TITLE VIII — GENERATING ANTIBIOTIC INCENTIVES NOW (GAIN) sections 801,802,803 provide designated candidate antibiotics : extension of exclusivity, priority review, fast track approval.

Breakthrough therapy[edit]

FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation for drugs that may be significantly better treatments for serious diseases or conditions.[3]


Section 618 of the FDASIA directed the Secretary of Health and Human Services, acting through the Commissioner of the United States Food and Drug Administration, and in consultation with the Office of the National Coordinator for Health Information Technology and the Chairman of the Federal Communications Commission (FCC), to develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. The Health IT Policy Committee formed a FDASIA workgroup and issued recommendations to ONC, FDA, and FCC as of the September 4th, 2013 HIT Policy Committee meeting.[4]


External links[edit]