Food and Drug Administration Safety and Innovation Act

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.

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

The GAIN Act was passed to incentivize the development of new antibiotics in response to the growing threat of antibiotic resistance and a lack of antibiotic products in pharmaceutical manufacturers' pipelines. The legislation extends by five years the exclusivity by which antibiotics that treat serious or life-threatening illnesses can be sold without generic competition. The extra five years of market protection is in addition to any other existing exclusivity, including those available under the Hatch-Waxman Act (3 to 5 years), orphan drug (7 years), or pediatric exclusivity (6 months). Under "Title VIII — The GAIN Act sections 801, 802, 803 provide designated candidate antibiotics ("qualifying infectious disease products" or QIDPs) extension of exclusivity, priority review, and fast track approval. As of Sept. 2013, the FDA had issued 24 QIDP designations for 16 chemical entities.

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