New Bill Supports a Limited Use Pathway for Accelerated Approval of Antibiotics

US Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) recently introduced a bill to permit the FDA to speed the approval of antibiotics through a new drug approval pathway.

The Promise for Antibiotics and Therapeutics for Health (PATH) Act aims to combat the growing problem of antibiotic-resistant bacteria. Despite the increasing threat, fewer than 10 new antibiotics have been introduced since 2000, according to the senators.

“Antibiotic-resistant bacteria pose serious and unique challenges to healthcare professionals,” said Senator Bennet. “This bill will allow new antibiotics that show promise combating these bacteria to reach patients more quickly and save lives. It will also encourage bioscience companies to invest in innovative research to develop these lifesaving drugs.”

The legislation would authorize the FDA to accelerate an antibiotic’s approval for a limited, high-risk patient population if the medication treats a serious condition and addresses an unmet need. The label would also include a message from the FDA stating the medication’s intended use in only the specific populations the drug was approved for.

The bill also allows for the pathway’s potential expansion to other therapeutic areas.

According to an article posted on the Web site of the Regulatory Affairs Professionals Society, the PATH Act is similar to the Antibiotic Development to Advance Patient Treatment (ADAPT) Act introduced in 2013. However, the PATH Act does not require the FDA to identify “breakpoints” at which a dose could lead to bacteria resistance.—Jolynn Tumolo

References

Bennet, Hatch propose a streamlined pathway for approval of antibiotics [press release]. Orrin Hatch United States Senator for Utah: Washington, DC; December 10, 2014.

Gaffney A. Bill seeks creation of new pathway for antibiotic drug approvals. Regulatory Affairs Professionals Society: Rockville, MD; December 11, 2014.