Addressing the Economic Hurdles Facing Antibiotic Innovation

As antibiotic resistance continues to rise, the development pipeline for new drugs to treat bacterial infections is dwindling.

Bringing any new medicine to market involves a great deal of time, effort, and expense. Antibiotics generate less revenue than blockbuster drugs such as those for high blood pressure or cholesterol—rather than a drug that is taken daily for life, antibiotics are taken for a week or so a few cycles over a lifetime—so manufacturers have little economic incentive to develop new ones.

To help overcome these challenges and stimulate development of new antibiotics, the Food and Drug Safety and Innovation Act of 2012 included the Generating Antibiotic Incentives Now (GAIN) provisions. GAIN increases the commercial value of antibiotics intended for serious or life-threatening infections by extending by five years the exclusivity period during which the drugs can be sold without generic competition. As of January 2015, at least 27 novel antibiotics have been designated as qualified infectious disease products under GAIN.

Antibiotics
Antibiotics
Issue Brief

GAIN: How a New Law is Stimulating the Development of Antibiotics

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Issue Brief

On July 9, 2012, the Generating Antibiotic Incentives Now, or GAIN, provisions were signed into law by President Barack Obama as part of the Food and Drug Administration Safety and Innovation Act. This bipartisan legislation extends by five years the exclusivity period during which certain antibiotics—those that treat serious or life-threatening infections—can be sold without generic competition. This additional period of exclusivity increases the potential for profits from new antibiotics by giving innovative companies more time to recoup their investment costs.

Kids and Antibiotics
Kids Antibiotics
Data Visualization

Antibiotics Currently in Global Clinical Development

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Data Visualization

As of December 2019, approximately 41 new antibiotics with the potential to treat serious bacterial infections were in clinical development, and four were approved since the previous update in June 2019. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be approved for patients.

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