Patents key for antibiotics
Grabrowski and Dimasi, 2015. (Henry Grabowski is an authority on the economics of the pharmaceutical industry, the economics of innovation, and government regulation of business and is a Duke University professor; Dr. DiMasi is Director of Economic Analysis at the Tufts Center for the Study of Drug Development and Research Associate Professor at Tufts Medical School, Tufts University, February 2015, “The Roles Of Patents And Research And Development Incentives In Biopharmaceutical Innovation”. https://www.healthaffairs.org/doi/10.1377/hlthaff.2014.1047#:~:text=Patents%20and%20other%20forms%20of%20intellectual%20property%20protection%20are%20generally,costs%20of%20imitation%20are%20low.)
Since the 1990s various health agencies have identified growing antibiotic resistance as a major health threat, but few new antibiotics have been introduced. 31 Concerns about resistance have increased. However, reserving new antibiotics as drugs of “last resort” constrains their sales. Together with rising R&D costs and other challenges, this created a disincentive to investment in developing new antibiotics.
The Generating Antibiotic Incentives Now (GAIN) Act of 2012 was designed to strengthen the pipeline of antibiotic and antifungal drugs for life-threatening or other serious infections by providing several economic incentives ( Exhibit 2 ). These include a five-year extension of regulatory exclusivity from generic competition (supplementing the five years of exclusivity for new small-molecule drugs under the Hatch-Waxman Act and any applicable orphan drug and pediatric exclusivity). These drugs are also eligible for the FDA’s Fast Track and Priority Review programs. Fast Track status provides more frequent interactions with FDA review teams and the opportunity for a “rolling review,” or review of portions of the application before the complete application is submitted. Priority reviews are expected to be completed by the FDA within six months—substantially faster than the ten months required for a standard review.
Thirty-five antibiotics have been designated as qualified infectious disease products under the GAIN Act, making them eligible for these incentives, including extended regulatory exclusivity, if the FDA approves them. 32 As of December 2014, four had been approved: dalbavancin, tedizolid, oritavancib, and a combination of ceftolozane and tazobactam. 33 The FDA is also developing guidance