Senate HELP Committee holds markup for PATH Act streamlining antibiotic approval

DISTRICT OF COLUMBIA — The Senate Health, Education, Labor, and Pensions (HELP) Committee held a markup on Wednesday to consider the Promise for Antibiotics and Therapeutics for Health — or PATH — Act, sponsored by Senators Orrin G. Hatch, R-Utah, and Michael Bennet, D-Colo.  This legislation would create a new drug approval pathway to streamline access, bolster innovation and encourage development of potentially life-saving antibiotic drugs for patients.

“Superbugs,” 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-resistant bacteria kills thousands of Americans each year, less than ten new antibiotics have made it to market since 2000. Antibiotic-resistant bacteria is also a significant concern to U.S. troops, affecting more than a third of returning Iraq and Afghanistan veterans, according to the Department of Defense.

Hatch called the problem a “critical threat.” He said:

Sixty-three percent of infectious disease doctors have treated patients with infections that did not respond to any antibiotics. Two million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 23,000 people die annually from these infections. A dearth of antibiotic drugs in development compounds this crisis. Consider that almost three decades have passed without the discovery of new types of antibiotics. We need to develop new antibiotics to treat the most serious of superbugs, and the PATH Act would significantly spur such action.

In an effort to address some of the significant regulatory obstacles hindering antibiotic development and patient access to life-saving treatments, the Promise for Antibiotics and Therapeutics for Health Act would permit the Food and Drug Administration to approve an antibacterial drug for a limited patient population upon determining that the drug treats a serious or life-threatening condition and addresses an unmet need. In addition, the bill includes several provisions to guide appropriate use of antibiotics approved under this pathway, such as labeling and promotional material requirements.

“Over the last few years we’ve experienced a lag in the development of new antibiotic treatments,” Bennet said. “We need new drugs to fight antibiotic-resistant bacteria that pose serious and unique challenges to health care professionals, veterans, and vulnerable populations. This bill will encourage research and development of new drugs that could save the lives of thousands of Americans each year.”

See full text of Promise for Antibiotics and Therapeutics for Health Act here.

 

Letters of Support for the PATH Act:

  • Pew Charitable Trust 
  • Infectious Diseases Society of America
  • National Military and Veterans Alliance
  • The Flag and General Officers’ Network
  • The following healthcare providers, hospitals, pharmacists, clinical laboratory scientists and medical microbiologists, public health experts, patients and advocates. [LINK]
    •  Alliance for Aging Research
    • Alliance for the Prudent Use of Antibiotics
    • American Academy of Allergy, Asthma & Immunology
    • American Academy of Pediatrics
    • American Association of Bovine Practitioners
    • American Gastroenterological Association
    • American Public Health Association
    • American Society for Microbiology
    • American Society of Transplant Surgeons
    • American Thoracic Society
    • Association for Professionals in Infection Control and Epidemiology Association of State and Territorial Health Officials
    •  Cempra, Inc.
    • Center for Foodborne Illness Research & Prevention
    • Dignity Health
    • HIV Medicine Association
    • Immune Deficiency Foundation
    • Infectious Diseases Society of America
    • Making-A-Difference in Infectious Diseases
    • March of Dimes
    • National Association of Pediatric Nurse Practitioners
    •  ONCORD, Inc.
    • Pediatric Infectious Diseases Society
    • Research!America
    • Society for Healthcare Epidemiology of America
    • Society of Critical Care Medicine
    • Society of Infectious Diseases Pharmacists
    • The Pew Charitable Trusts
    • Theravance Biopharma
    • Trust for America’s Health
    • UPMC Center for Health Security

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