H.R. 3742 was introduced December 12, 2013 by Reps. Phil Gingrey (R-GA) and Gene Green (D-TX).

Allows FDA to approve an antibacterial or antifungal drug intended to treat a life-threatening disease or condition in a limited population for which there is an unmet medical need.

Requires labeling of drugs approved for a limited and specific population of patients.

Allows withdrawal of limited population approval requirements if the drug is subsequently approved without the limited population.

Directs FDA to use the National Healthcare Safety Network or other system to monitor the use of antibacterial and antifungal drugs, and changes in bacterial and fungal resistance to drugs and to make the data publicly available.

Directs FDA to identify upon approval and subsequently update susceptibility test interpretive crtieria for antibacterial drugs, and evaluate new/updated criteria published by standards development organizations on a quarterly basis.

Republican Sponsors

Phil Gingrey (GA)

Marsha Blackburn (TN)

Bill Cassidy (LA)

Renee Ellmers (NC)

Morgan Griffith (VA)

Leonard Lance (NJ)

Bob Latta (Ohio)

Pete Olson (TX)

Mike Pompeo (KS)

John Shimkus (IL)

Ed Whitfield (KY)

Democrat Sponsors

Gene Green (TX)

John Barrow (GA)

GK Butterfield (NC)

Diana DeGette (CO)

John Dingell (MI)

Eliot Engel (NY)

Anna Eshoo (CA)

Jim Matheson (UT)

Doris Matsui (CA)

Paul Tonko (NY)

John Yarmuth (KY)

Supporters of ADAPT include the Infectious Diseases Society of America, the Pew Charitable Trusts, the Antimicrobial Innovation Alliance.

AIA is a client of The McManus Group. Members of AIA include Achaogen, Astellas, AstraZeneca, Forest Labs, GlaxoSmithKline, Merck, and the Medicines Company.

Pew sent a December 12 letter of support with two suggestions: strengthen the labeling requirements by requiring prominently placed language or other visual elements, and limiting the bill to just drugs for bacterial infections, not those for antifungal infections.

IDSA also supports the inclusion of a logo or other visual means to mark the drugs approved under the pathway, as does a group of four public health organizations (American Public Health Association, Association of State and Territorial Health Officials, National Association of County and City Health Officials, and Trust for America’s Health), whose letter supports a visual element.

Pew also sent a February 26 letter of support that was signed by 31 other organizations, including the American Medical Association, the American College of Surgeons, Treatment Action Group, and Trust for America’s Health.

The Antibiotics Working Group supports the direction and intent of ADAPT but is still working on suggestions for improvement, which it will then communicate to Congress. Members of AWG include: Cempra, Durata, Optimer, Melinta, The Medicines Company, and Theravance.

A full list of supporters, compiled from all letters, is below:

Infectious Diseases Society of America, Pew Charitable Trusts, Antimicrobial Innovation Alliance, AIDS Action Baltimore, Inc., Alliance for Aging Research, American Academy of Otolaryngology-Head and Neck Surgery, American Academy of Pediatrics, American College of Preventive Medicine, American College of Rheumatology, American College of Surgeons, American Gastroenterological Association, American Medical Association, American Thoracic Society, Association for Professionals in Infection Control and Epidemiology, Center for a Livable Future, Coalition of State Rheumatology Organizations, Council of State and Territorial Epidemiologists, Dignity Health, Food Animal Concerns Trust, Harm Reduction Coalition, HIV Medicine Association, National Association of County and City Health Officials, National Association of Pediatric Nurse Practitioners, National Coalition of STD Directors, National Foundation for Infectious Diseases, Pediatric Infectious Diseases Society, Society for Healthcare Epidemiology of America, Society of Critical Care Medicine, Society of Infectious Disease Pharmacists, Treatment Action Group, Trust for America’s Health, UPMC Center for Health Security, American Public Health Association, Association of State and Territorial Health Officials, Cubist, AstraZeneca. (Cubist and AstraZeneca are both part of AIA but also sent their own letters of support.)

H.R. 4187 was introduced March 11, 2014 by Reps. Peter Roskam (R-IL) and Danny Davis (D-IL).

Would provide for permanent additional payment to be made with respect to discharges involving new antimicrobial drugs on or after October 1, 2014.

Defines “new antimicrobial drugs” as those with indications first approved for use on or after January 1, 2014 that are indicated to treat infections caused by, or likely caused by, a qualifying pathogen – here the bill refers to the statute created by GAIN. They also must be used in facilitates that participate in the CDC’s National Healthcare Safety Network’s Antimicrobial Use and Resistance module or similar reporting programs.

Directs FDA to first publish a list of the new antimicrobial drugs in the Federal Register.

Is budget neutral via a lower base rate for the Inpatient Prospective Payment System hospital: for discharges that occur in a fiscal year, beginning with FY15.

Republican Sponsors

Peter Roskam (IL)

Larry Bucshon (IN)

Lynn Jenkins (KS)

Phil Gingrey (GA)

Democrat Sponsors

Danny Davis (IL)

Linda Sanchez (CA)

Supporters of DISARM include: the Infectious Diseases Society of America and the Antimicrobial Innovation Alliance.

IDSA sent a March 7 letter to Reps. Roskam and Davis expressing support and requesting they modify the provision that would require prescribing hospitals to participate in the CDC’s National Healthcare Safety Network’s Antimicrobial Use and Resistance module. IDSA notes that many hospitals are not prepared to participate in the module, and in the meantime recommends the bill require participating hospitals to instead utilize a CDC-based registry of patients using the drugs covered by the bill.

AIA sent a March 11 statement of support.

The Pew Charitable Trusts has not yet taken a position on DISARM.

The Antibiotics Working Group supports the direction and intent of DISARM but is still working on suggestions for improvement, which it will then communicate to Congress. Members of AWG include: Cempra, Durata, Optimer, Melinta, The Medicines Company, and Theravance.

Antibiotic Incentive Legislation: Can Reimbursement Horn In?

More from Legislation

More from Pink Sheet