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WASHINGTON, D.C. — Sens. Orrin G. Hatch and Michael Bennet reintroduced legislation Friday 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.

Hatch said:

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. 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.

Bennet said:

Bioscience companies, particularly in Colorado, are developing new drugs and technologies faster than we’ve ever seen before, but there is a lag in antibiotic treatments. We need new drugs to fight antibiotic-resistant bacteria that are posing serious and unique challenges to health care professionals. This bill will encourage investment in new drugs that could save the lives of thousands of Americans each year.

Infectious Diseases Society of America

“Patients are dying from multi-drug resistant infections, and we desperately need new antibiotics to save their lives. The PATH Act will create a feasible approval pathway that will allow these drugs to be brought to market,” Infectious Diseases Society of America’s president, Dr. Steve Calderwood, said.

“Importantly, the PATH Act will not only help spur the development of urgently needed new antibiotics,” Calderwood said, “the legislation will also help ensure these precious new drugs are used appropriately to limit the development of resistance.”

“There is clear agreement among medical, scientific, and public health leaders that the federal government must act to stimulate development of urgently needed new antibiotics,” Calderwood said. “There is broad support for the limited population antibacterial drug pathway which the PATH Act would establish. Congress must continue the momentum driving this issue on behalf of patients. IDSA looks forward to working with Senators Bennet and Hatch to enact the PATH Act.”

Pew Charitable Trusts

“This new pathway tackles an important health problem with an approach that is good for both public health and drug development,” Allan Coukell, senior director of health programs at the Pew Charitable Trusts, wrote in a letter to Sens. Hatch and Bennet.

The Science in Service to Humanity Foundation

Rear Admiral James J. Carey, national chairman of the Flag and General Officers’ Network and chairman of the Science in Service to Humanity Foundation in Washington, D.C., wrote in an op-ed in Roll Call Friday morning:

The time is right. There is broad support for updating the antibiotics approval process from industry and the nonprofit sector. There is bipartisan support on both sides of the Hill and at the White House. For the sake of our returning troops and the millions of people worldwide at risk of untreatable infections, I hope this legislation is among the first bills to pass the new Congress.

National Venture Capital Association

“We commend Senators Bennet and Hatch for introducing this important piece of legislation,” National Venture Capital Association President and CEO Bobby Franklin said. “This bipartisan effort is an example of steps we need to take to ensure the United States remains the global hub for medical innovation and to promote investment in desperately-needed antibiotics that will improve the lives of everyday Americans as well as our veterans returning from overseas deployment.”

Background

“Superbugs” — or bacteria that are substantially resistant or unresponsive to any existing and available antibiotic — are an increasingly urgent public health threat, both at home and abroad.

While antibiotic resistance continues to cost tens of thousands of lives in the United States each year, less than ten new antibiotics have made it to market since 2000. Antibiotic-resistant bacteria is also a significant concern to our troops, affecting more than a third of returning Iraq and Afghanistan veterans, according to the Department of Defense.

In an effort to address some of the significant regulatory obstacles facing antibiotic development and hindering patient and veteran access, the Promise for Antibiotics and Therapeutics for Health Act, or PATH, would permit the Food and Drug Administration 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 FDA indicating their 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.

Submitted by the Offices of Sen. Orrin Hatch

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