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: 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 … Next Page »