Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

Regulatory NewsRegulatory News | 11 December 2014 |  By 

New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria.

A Limited Population Pathway

The bill, the Promise for Antibiotics and Therapeutics for Health (PATH) Act, was introduced on 10 December 2014 by Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT).

At its core, the legislation calls for the creation of a "limited population pathway for antibacterial drugs." The pathway would allow a sponsor of a new drug to seek approval for the product intended to treat "a serious or life-threatening disease, condition or indication" that is currently not adequately served by existing therapies.

The pathway could only be used if the sponsor could identify a specific population in which the medical product would be used.

The overall hope of the legislation is that by limiting the assessment of the drug to the specific population —presumably a small and extremely sick population at that—drug sponsors might be able to obtain approvals both more quickly and more easily.

 FDA Antibiotic Approvals

That's important because over time, antibiotic approvals in the US have been on a steady decline, even as bacteria resistant to antibiotics have been steadily increasing. A recent report authored by the President's Council of Advisors on Science and Technology (PCAST) said at least 23,000 deaths and two million illnesses in the US each year are attributable to antibiotic resistance.

That same report also called on the US government, and specifically the US Congress, to permit the US Food and Drug Administration (FDA) to be able to approve drugs "based on demonstration of safety and efficacy in specific patients infected with antibiotic-resistant bacteria, while discouraging use in other patient populations."

Read more about PCAST's report in our article, US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives."

Path Act Details

Hatch and Bennett's legislation seems to be a response to the PCAST report. In addition to focusing on "limited" populations, their legislation also focuses on the idea of "sufficient evidence." FDA is permitted to approve drugs based on "traditional endpoints, alternate endpoints, or a combination or traditional and alternate endpoints, and, as appropriate, small clinical data sets."

Regulators would also be permitted to rely on "supplemental data, including preclinical evidence, pharmacologic or pathophysiologic evidence, nonclinical susceptibility, pharmacokinetic data and other such confirmatory evidence."

Drugs approved through the pathway would be required to be labeled with a special logo or statement indicating that the drug is only approved for use in a limited population, and all advertisements for the product would need to be submitted to FDA in advance.

FDA would also be required to issue draft guidance on the pathway within 18 months of the legislation being passed into law, including how the program "can be expanded to other therapeutic areas in addition to antibacterial infections."

Drugs approved for limited use could later apply to have their indications broadened to more general use populations, which would remove marketing and labeling restrictions. However, FDA does not have—and the legislation does not grant—the authority to prevent doctors from using limited population drugs off-label.


The legislation is also quite similar to an earlier piece of legislation introduced in 2013, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act. That legislation, like the PATH Act, calls for the creation of a limited use pathway. Unlike the ADAPT Act, however, the PATH Act does not call for FDA to identify "breakpoints"—the point at which a particular dose would be expected to lead to resistance in bacteria.

                Read more on legislative efforts to affect FDA in our FDA Legislation Tracker.

Researchers from the Pew Charitable Trusts have already praised the PATH Act, saying the bill will "help ensure that patients who can be treated with other antibiotics are not put at unnecessary risk and will also help preserve the effectiveness of these vital new medicines." The group did say it hoped legislators would limit the bill to just antibiotics, however.


Promise for Antibiotics and Therapeutics for Health (PATH) Act

Press Statement


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