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 requires the FDA to submit annually to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions, a report on the progress of the FDA in achieving the goals of the administration, future plans of the FDA, and the progress of the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research in achieving such goals.
[2] Title II extends through FY2017 the authority of the FDA to assess and collect fees for medical device applications and submissions.
It authorizes the FDA to prohibit the sponsor of an investigation of the effectiveness of a medical device from conducting such investigation (issuing a clinical hold) if the FDA makes a determination that the device represents an unreasonable risk to the safety of the participants of the clinical trial.
It authorizes the FDA to order post-marketing surveillance for medical devices at the time of their approval or clearance or at any time thereafter and requires device manufacturers to start surveillance not later than 15 months after the date the FDA issues an order.
Medical devices for small or unique populations that are created or modified to comply with the order of an individual physician and that are designed to treat a unique pathology or physiological condition that no other device is domestically available to treat are exempted from post-marketing approval requirements.
[2] Title VII imposes FDA registration requirements for domestic and foreign drug establishments.
It requires an establishment that is engaged in the manufacture or preparation of a drug to provide the FDA with records or other information in advance of an inspection.
It authorizes the FDA to destroy counterfeit or adulterated imported drug products that have minor monetary value or a reasonable probability of causing serious adverse health consequences or death.
[5] A "qualified infectious disease product" is defined as an antibacterial or antifungal drug intended to treat serious or life-threatening infections.
[2] Breakthrough Therapy Designation was created for drugs that may be significantly better treatments for serious diseases or conditions.
[8] On November 13, 2013, the FDA approved obinutuzumab (trade name Gazyva) by Hoffmann-La Roche[9] for chronic lymphocytic leukemia making it the first drug to receive the breakthrough therapy designation.
It allows a hospital that is owned and operated by the same entity and that shares access to databases with drug order information for its patients to repackage a drug in shortage (i.e., divide its volume into smaller amounts) and transfer it to another hospital within the same health system without incurring otherwise applicable FDA registration requirements.
It requires the FDA to work with other regulatory authorities and international organizations to encourage uniform clinical trial standards for medical products worldwide, and accept data from clinical investigations conducted outside of the US in determining whether to approve a drug.