Food and Drug Administration Safety and Innovation Act

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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 (GAIN) Act[edit]

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.[3] 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).[4] 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.[5]

In response to the GAIN Act, the FDA announced in Sept. 2012 that they were creating The Antibacterial Drug Development Task Force to assist in developing and revising guidance related to antibacterial drug development. The task force consisted of a multi-disciplinary group of 19 CDER scientists and clinicians who were charged with identifying priority areas and developing and implementing possible solutions to the challenges of antibacterial drug development.[6]

Breakthrough therapy[edit]

Section 902 of the Act provides for a new designation - Breakthrough Therapy Designation for drugs that may be significantly better treatments for serious diseases or conditions.[7] On November 13, 2013 the FDA approved obinutuzumab (trade name Gazyva) by Hoffmann-La Roche[8] for chronic lymphocytic leukemia making it the first drug to receive the breakthrough therapy designation.[9][10]:358


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.[11]


  1. ^ Vashi, Sonam (September 26, 2012). K2 Trend Not Slowing Down WebMD Medical News via KOKI-TV
  2. ^ Marder, Jenny (September 20, 2012). Bath Salts: The Drug That Never Lets Go. PBS NewsHour
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  5. ^ Derrick Gingery, "Antibiotic Development: As FDA's QIDP List Grows Longer, Will Firms GAIN Less?" The Pink Sheet, 9/13/13
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  8. ^ "Final Recommendation for Obinutuzumab (Gazyva) for CLL Pan-Canadian Oncology Drug Review (pERC) Meeting: December 18, 2014; Early Conversion: pCODR" (PDF). Pan-Canadian Oncology Drug Review via Canadian Agency for Drugs and Technologies in Health. 27 January 2015. Retrieved 22 November 2015. 
  9. ^ FDA approves Gazyva for chronic lymphocytic leukemia: Drug is first with breakthrough therapy designation to receive FDA approval, FDA News Release, FDA, November 13, 2013, retrieved July 20, 2015 
  10. ^ Kakkar, A.; Balakrishnan, S. (October 2015). "Obinutuzumab for chronic lymphocytic leukemia: promise of the first treatment approved with breakthrough therapy designation". Journal Of Oncology Pharmacy Practice. Ipswich, MA. 21 (5): 358–363. doi:10.1177/1078155214534868. ISSN 1078-1552. Retrieved 23 November 2015.  via EBSCO
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