US Senate Introduces Legislation for New Drug Approval Pathway for Drug-Resistant Antibiotics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-20-2015 02:50


Senators Orrin G. Hatch, R-Utah, and Michael Bennet, D-Colo, have re-introduced legislation to create a new drug approval pathway to streamline access and encourage innovation and development of potentially lifesaving antibiotic drugs for patients, particularly veterans who have encountered antibiotic-resistant bacteria while overseas.

“America has always been a beacon for innovation and discovery. The PATH Act will allow health experts to more easily develop new treatments for antibiotic-resistant bacteria, and make real progress in preventing a great number of illnesses and deaths in the United States,” Hatch said in a press statement. “I was pleased our proposal received such a positive response when we introduced it in the end of the last Congress, and I look forward to working with Senator Bennet and others to enact it into law."

The Promise for Antibiotics and Therapeutics for Health (PATH) Act would permit the US Food and Drug Administration (FDA) to accelerate an antibacterial drug’s approval for an identifiable, limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need. In addition, the bill requires a drug’s label to include special designation from the FDA indicating its intended use in limited, high-risk populations approved under this pathway. The bill also calls for further guidance and potential expansion to other appropriate therapeutic areas.

Source: Offices of Sen. Orrin Hatch and Michael Bennet


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