By: Janet Woodcock, M.D.
You may have been hearing about a variety of Federal Government actions to address the growing need for new antibiotics. For instance, in an FDA Voice blog last week Commissioner Hamburg discussed the President’s national strategy for Combating Antibiotic Resistant Bacteria (CARB) and our collaboration with a wide variety of organizations to address this issue. You may have also noticed another recent blog talking about FDA’s work on the Generating Antibiotics Incentives Now Act (GAIN Act), the Antibacterial Drug Development Task Force, a public meeting, a Federal Register Notice, and multiple guidance documents, all aimed at building up the nation’s arsenal of effective antimicrobial drugs.
There are many government activities in this area, so I’d like to boil things down a bit. A critical fact is that our efforts are starting to show signs of success. Over the last few months, FDA has approved three new antibiotics to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria like Staphylococcus aureus, including methicillin-resistant strains, also known as MRSA infections.
- On May 23, FDA approved Dalvance (dalbavancin), an injectable drug, administered intravenously in two doses one week apart.
- On June 20, FDA approved Sivextro (tedizolid phosphate), available for intravenous and oral use, administered once daily for six days.
- On August 6, FDA approved Orbactiv (oritavancin), an injectable drug administered as a single dose to comprise a full course of therapy.
In these approvals, the drug’s manufacturer was able to take advantage of recently enacted incentives to help bring new antimicrobials to market. Each of these drugs was approved after being designated as a Qualified Infectious Disease Product (QIDP) under the GAIN Act. As part of this QIDP designation, FDA’s review of the drug application was expedited. The designation also qualified the drugs for five years of marketing exclusivity to be added to certain exclusivity already provided by the Food, Drug, and Cosmetic Act. To date, FDA has granted the QIDP designation to 39 antibiotics under development.
Development of these three new antibiotics was also helped a great deal by the scientific collaboration among stakeholders dedicated to advancing new antimicrobial therapies. The Biomarkers Consortium of the Foundation for the National Institutes of Health, academic and industry experts, and other contributors made valuable recommendations to the FDA regarding designing scientifically sound studies to show the effectiveness of these drugs in clinical trials.
We still have a long way to go in getting a leg up on building a new and more effective arsenal of antimicrobial products. And once approved, it will be critical for health care professionals to appropriately prescribe these new antibiotics. But with ongoing collaborative, concerted efforts by the many public and private stakeholders, we can continue to advance and help build a national antibacterial research and development enterprise capable of bringing new drugs to the patients who need them. These three approvals are an encouraging start!
Janet Woodcock, M.D., is the Director of FDA’s Center for Drug Evaluation and Research
Learn more by reading Dr. Woodcock’s testimony: 21st Century Cures: Examining Ways to Combat Antibiotic Resistance and Foster New Drug Development.: