IDSA : Legislative Efforts for 10x20

09/19/2012

IDSA Letter to HHS on Antimicrobial Resistance and Immunization Policies (PDF)

IDSA urges Secretary Sebelius to act on Senate recommendations regarding antimicrobial resistance, antibiotic research and development, and immunization policies.

09/07/2012

IDSA Summary of Antibiotic Incentives in the FDA Safety and Innovation Act (PDF)

IDSA summary of antibiotic incentives in the FDA Safety and Innovation Act.

06/19/2012

American Medical Association (AMA) Supports IDSA's Limited Population Antibiotic Drug (LPAD) Proposal (PDF)

The AMA House of Delegates voted to adopt a resolution introduced by IDSA in support of the establishment of the LPAD approval mechanism.

05/07/2012

IDSA Supports House Antibiotics Legislation (PDF)

IDSA sent the House Energy and Commerce Committee a letter of support for the antibiotic provisions included in their bill to reauthorize the Food and Drug Administration (FDA) Prescription Drug User Fee Agreement (PDUFA), and urged the Committee to further strengthen the legislation.

04/24/2012

IDSA Supports Senate Antibiotics Legislation (PDF)

IDSA submitted a letter of support for the antibiotic provisions included in the Senate bill to reauthorize the Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA).

04/12/2012

Letter of Support from Medical Societies and Public Health and Patient Groups for the LPAD FDA Product Approval Pathway (PDF)

Over 20 organizations representing medical societies, patients, public health, health systems and other stakeholders support the LPAD approval mechanism concept and urge Congress to establish it as a necessary complement to the economic incentives for antibacterial development that Congress is currently considering for inclusion in PDUFA.

04/12/2012

Companies Support IDSA's Limited Population Antibacterial Drug (LPAD) Proposal (PDF)

One dozen pharmaceutical companies signed a letter to Congress in support of the LPAD approval pathway (as proposed by IDSA) for antibacterials to treat serious or life-threatening infections with few, if any, satisfactory therapeutic options.

04/12/2012

IDSA Urges U.S House to Create Limited Population Antibacterial Drug (LPAD) Approval Pathway (PDF)

IDSA commented on the antibiotic R&D antibiotic incentives provisions of the U.S. House Committee's draft PDUFA reauthorization legislation, calling for the establishment of the LPAD approval mechanism for antibacterials that treat serious infections where insufficient satisfactory treatment options exist as well as other supportive measures.

04/09/2012

IDSA Urges Senate to Create Limited Population Antibacterial Drug (LPAD) Approval Pathway (PDF)

IDSA commented on the Senate HELP Committee's "Incentivizing New Antibiotic Development" March 29, 2012 draft for stakeholder discussion, calling for the establishment of the LPAD approval mechanism at FDA and other supportive measures as part of the PDUFA reauthorization legislation.

02/22/2012

50 Organizations Urge Congress to Enact Antibiotic R&D Incentives

IDSA secured the support of 49 additional organizations who agree Congress should fix the broken antibiotic pipeline in upcoming FDA user fee legislation. [Letter to U.S. House leaders is posted]

11/22/2011

IDSA Letter to Sponsors of the Generating Antibiotic Incentives Now (GAIN) Act (PDF)

IDSA applauds GAIN sponsors' leadership and encourages new provisions to provide additional exclusivity incentives to spur antibiotic R&D, provide federal leadership to explore options for public private partnerships to focus on early antibiotic discovery research, and ensure appropriate use of antibiotics.

06/15/2011

IDSA Comments on New Legislation, H.R. 2182, the Generating Antibiotic Incentives Now (GAIN) Act (PDF)

The GAIN Act, introduced in the U.S. House of Representatives, provides an excellent starting point for discussing the right combination of incentives necessary to jumpstart novel antibiotic (and related diagnostic) research and development.

11/20/2009

IDSA's Initial Comments on the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) (PDF)

In a letter to President Obama and Swedish Prime Minister Reinfeldt, IDSA supports the new TATFAR, but seeks the creation of an Antibacterial Drug Development Work Group housed at the White House to oversee the development of incentives to spur antibiotic development.

12/17/2007

IDSA Urges Congressional Action on Antibiotic R&D Incentives Before 2007 Ends (PDF)

Congress has the opportunity to enact an incentive to encourage new research on "older" antibiotics, and IDSA is urging them to act.

11/15/2007

IDSA Endorses 50% Tax Credit for ID Product Research & Development (PDF)

New legislation, S. 2351, introduced by Senator Charles Schumer (D-NY), if enacted, will help to spur the development of new antibiotics, antiviral drugs, vaccines, diagnostics, and biological products to address MRSA, gram-negative bacterial infections, XDR-TB, and other dangerous drug-resistant and other infectious pathogens.

09/21/2007

Breaking News: Congress Passes Legislation Intended to Strengthen Antibiotic Pipeline (PDF)

New antibiotic provisions, many of which IDSA prompted and promoted, were included in the FDA bill. President Bush is expected to sign the bill into law.

09/20/2007

IDSA Applauds Inclusion of Antimicrobial Resistance Provisions in New FDA Law (PDF)

IDSA expressed disappointment, in a letter to congressional leaders, that one important antibiotic development incentive was dropped from the legislation just prior to passage and asked Congress to include it in other pending legislation this year.

06/19/2007

IDSA Letter to NIAID and CDC Requesting a Strengthened Federal Response to Antimicrobial Resistance (PDF)

In a letter to Dr. Anthony Fauci, NIAID, and Julie Gerberding, CDC, IDSA called for the creation of an NIH/CDC joint antimicrobial resistance strategic research plan as well as the joint establishment of an Antimicrobial Resistance Clinical Research and Public Health Network as proposed in the Strategies to Address Antimicrobial Resistance Act.

11/09/2005

IDSA Opposes Stifling Small Business Admin. Action Affecting Biotech and Device R&D (PDF)

Building on its "Bad Bugs, No Drugs" effort, IDSA works with coaltions to support a legislative fix.

10/24/2005

IDSA Supports Provisions to Encourage the Development of New Classes of Antibiotics and Anti-Infective Products (PDF)

IDSA supports market exclusivity for antibiotics that treat serious and life-threatening infections. The society responds to important legislation moving in the Senate.

10/04/2005

IDSA Letter to Senator Burr on Bioshield II Incentives (PDF)

As the next version of key legislation is being negotiated, IDSA reiterates its belief that novel incentives are the solution to the future development of antibiotics.

07/05/2005

IDSA Endorses the Infectious Disease Research and Development Act of 2005 (PDF)

IDSA has endorsed H.R. 3154, The Infectious Diseases Research and Development Act of 2005, a bill sponsored by Congresswoman Barbara Cubin (D-WY). The bill, if enacted, will provide incentives for pharmaceutical and biotechnology companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent a “qualified infectious disease product.”

06/24/2005

IDSA Supports Unique Patent Solutions to Promote Antibiotic R&D (PDF)

IDSA letter to Senator Richard Burr, Chair Subcommittee on Bioterrorism and Public Health on unique patent solutions to promote antibiotic research and development.

View all Legislative Efforts documents for 10x'20

IDSA Letter to HHS on Antimicrobial Resistance and Immunization Policies (PDF)

IDSA Summary of Antibiotic Incentives in the FDA Safety and Innovation Act (PDF)

American Medical Association (AMA) Supports IDSA's Limited Population Antibiotic Drug (LPAD) Proposal (PDF)

IDSA Supports House Antibiotics Legislation (PDF)

IDSA Supports Senate Antibiotics Legislation (PDF)

Letter of Support from Medical Societies and Public Health and Patient Groups for the LPAD FDA Product Approval Pathway (PDF)

Companies Support IDSA's Limited Population Antibacterial Drug (LPAD) Proposal (PDF)

IDSA Urges U.S House to Create Limited Population Antibacterial Drug (LPAD) Approval Pathway (PDF)

IDSA Urges Senate to Create Limited Population Antibacterial Drug (LPAD) Approval Pathway (PDF)

50 Organizations Urge Congress to Enact Antibiotic R&D Incentives

IDSA Letter to Sponsors of the Generating Antibiotic Incentives Now (GAIN) Act (PDF)

IDSA Comments on New Legislation, H.R. 2182, the Generating Antibiotic Incentives Now (GAIN) Act (PDF)

IDSA's Initial Comments on the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) (PDF)

IDSA Urges Congressional Action on Antibiotic R&D Incentives Before 2007 Ends (PDF)

IDSA Endorses 50% Tax Credit for ID Product Research & Development (PDF)

Breaking News: Congress Passes Legislation Intended to Strengthen Antibiotic Pipeline (PDF)

IDSA Applauds Inclusion of Antimicrobial Resistance Provisions in New FDA Law (PDF)

IDSA Letter to NIAID and CDC Requesting a Strengthened Federal Response to Antimicrobial Resistance (PDF)

IDSA Opposes Stifling Small Business Admin. Action Affecting Biotech and Device R&D (PDF)

IDSA Supports Provisions to Encourage the Development of New Classes of Antibiotics and Anti-Infective Products (PDF)

IDSA Letter to Senator Burr on Bioshield II Incentives (PDF)

IDSA Endorses the Infectious Disease Research and Development Act of 2005 (PDF)

IDSA Supports Unique Patent Solutions to Promote Antibiotic R&D (PDF)

Infectious Diseases Society of America