Senate committee recommends PATH Act for superbug treatment

A bill aimed at shortening the development time for superbug treatments was recommended today by the U.S. Senate Committee on Health, Education, Labor and Pensions, or HELP.

The Promise for Antibiotics and Therapeutics for Health (PATH) Act was among five bills endorsed during the final mark-up session for the HELP committee’s biomedical innovations agenda.

Lamar Alexander

HELP Chairman and Sen. Lamar Alexander, R-Tenn., said the committee’s remaining work includes solving the issue of funding as the Senate works toward passing a companion to the U.S. House of Representatives’ 21st Century Cures Act.

“If it’s the most important bill and has the promise of improving the health of virtually every American, we should make sure we finish this, and the sooner the better,” Alexander said during today’s executive session.

The PATH Act, or S. 185, seeks to establish a new limited population pathway for antibacterial drugs to treat serious or life-threatening infections where there is an unmet medical need for appropriate treatments. It was introduced in December 2014 by Sens. Michael F. Bennet, D-Colo., and Orrin G. Hatch, R-Utah.

Orrin G. Hatch

According to the Infectious Diseases Society of America, the increase in patients contracting and dying from multidrug-resistant pathogens that cannot be treated with existing antibiotics places a costly burden — in lives and money — on the American health care system.

The PATH Act will enable researchers to develop and bring to market new lifesaving antibiotics, the IDSA said in a statement recently after the HELP committee announced it would consider the bill. New antibiotics would be studied in smaller and faster ways and approved only for the patients who need them.

“Such an approach,” the IDSA said, “is necessary to enable the research and development of some of the most urgently needed new antibiotics, as some of the most deadly and highly resistant pathogens are currently infecting small numbers of critically ill patients, making it difficult or impossible to fill traditional, large clinical trials.”

Michael Bennet

According to Bennet, more than one-third of U.S. soldiers wounded in Iraq and Afghanistan have developed bacterial infections.

“These bacterial infections are particularly threatening for our nation’s military,” he said during the executive session. “This legislation takes a step forward in bringing these therapies to many deserving patients.”

Virtually everything the HELP committee has recommended in three executive sessions has had at least one Republican and one Democratic sponsor, according to Alexander, who said the committee was making “substantial progress.”

Still, funding issues remain.

Last July, the House voted 344-77 to pass the 21st Century Cures Act, which provided additional funding to the NIH and FDA while streamlining the development of new drugs and antibiotics. Funding for the NIH has been a sticking point between Republicans and Democrats as the Senate works on its own bill.

“I’m confident that working together we will figure out how to get this bill, along with some funding for the NIH, to the floor,” Bennet said. – by Gerard Gallagher

Disclosures: Alexander, Bennet and Hatch report no relevant financial disclosures.