In Search of Meaningful GAIN in Renewal of Prescription Drug Act

The repercussions of the Supreme Court’s recent ruling on the Affordable Care Act have largely overshadowed another key healthcare milestone—President Obama’s signing Monday of the Prescription Drug User Fee Act, also known as PDUFA V. Originally passed in 1992, PDUFA V re-authorizes the FDA to collect fees from drug sponsors to speed the review and approval of new drugs, and has been cited as a key reason why the U.S. is considered a world leader in providing patients access to innovative medicines. PDUFA is one of the rare pieces of legislation that has broad support among patients, the government, industry, and academia. Its timely reauthorization strengthens the U.S. healthcare system and facilitates access to potentially life saving new medicines.

One important area of life saving medicines highlighted in PDUFA V focuses on antibiotics, which I’ve followed closely as the CEO of San Diego’s Trius Therapeutics (NASDAQ: [[ticker:TSRX]]). The “Generating Antibiotic Incentives Now,” or GAIN Act, contains provisions that provide industry with incentives to develop innovative antibiotics to treat life-threatening infections caused by drug-resistant pathogens.

Why, you might ask, do we literally need an act of Congress to provide incentives to drug developers, especially in a political environment in which such actions have been viewed as “corporate welfare”? The answer lies in a near-perfect trifecta of ominous trends: the alarming growth of multidrug-resistant bacterial pathogens; the abandonment of antibiotic drug development by large pharmaceutical companies; and challenging

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Author: Jeff Stein

Jeff Stein is the president and CEO of San Diego's Trius Therapeutics. He joined the board of Rx3 Pharmaceuticals, the predecessor of Trius, in 2005 while serving as a Kauffman Fellow with Sofinnova Ventures. He became CEO in 2007 when the company was revamped and reincorporated as Trius. He also served as a Sofinnova venture partner from 2007 until 2010, and as director of venture development at UC San Diego from 2005 to 2006. He was previously executive vice president, chief scientific officer, and a board member of Quorex Pharmaceuticals, an anti-infectives company he founded in Carlsbad, CA, in 1999 that was acquired by Pfizer in 2005. Before that, Stein worked as the principal scientist at Diversa and at the private Agouron Institute. He was a distinguished postdoctoral fellow at the California Institute of Technology, and holds a doctorate in biochemistry and microbiology from UC San Diego.