Washington -- U.S. Representative Barbara Cubin called for increased research for drug-resistant infections today as the Centers for Disease Control announced they had isolated a U.S. citizen confirmed to be suffering from extensively drug-resistant tuberculosis (XDR TB).

"This patient is proof that the threat of drug-resistant infection is all too alive and present in America," Representative Cubin said. "The frightening reality behind this case is that anti-microbial resistance is an ever-growing threat to public health, and our currently available drugs no longer sufficiently treat diseases like XDR TB. Recognizing this threat, I have introduced legislation to spur the development of new drugs by providing a diverse set of incentives for companies of all size to invest in the research and development of new antibiotics, antivirals and vaccines to fight infectious diseases. The time is now to pass this legislation."Cubin’s bill, The Beating Bird-Flu In Research and Development (BIRD) Act provides a robust package of incentives to encourage and reward the research and development (R&D) of new drugs to combat newly emerging resistant diseases, including drug-resistant staph infections, life-threatening gram negative bacteria such as E.coli, influenza and XDR TB."Infectious diseases such as XDR TB have the ability to kill hundreds of thousands of people, yet there aren’t enough incentives for companies to invest in research and development of vaccines or treatments," Cubin said. "Congress can address this lack of market incentive by passing the bill I’ve introduced."The incentives listed in the BIRD Act include tax credits for product research and development, tax credits for manufacturing, patent extensions, and expedited approval by the Food and Drug Administration. "My own family has survived a scare with drug-resistant staph, and I have been approached by multiple medical experts who routinely battle this and other drug-resistant infections daily," Representative Cubin said. "We tend to falsely believe that pandemics and untreatable infections are relics of the past, and if we allow that thinking to persist, humanity will pay the ultimate cost. Congress has a responsibility to address these threats by stimulating new R&D."Below is a detailed summary of The Beating Infections Through Research and Development (BIRD) Act.

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Beating Infections Through Research and Development (BIRD) Act

Introduced by Representatives Barbara Cubin and Brian Baird

PURPOSE

To provide incentives for pharmaceutical companies and biotechnology companies to invest the in research and development of new antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify and treat newly emerging public health threats.

INCENTIVES FOR INFECTIOUS DISEASES PRODUCT DEVELOPMENT

Patent Protections

-Restoration of patent terms to account for the time lost during product approval.

-"Wild Card" patent extension – This allows a manufacturer to extend an eligible patent for a period of 2 years when a qualified infectious disease product is approved for use.

Fast-track Designation of qualified infectious disease products for FDA review

Speeds the time necessary to bring a product to market.

Small Business Incentive/End-stage Clinical Trials

-Many times, small pharmaceutical or biotech companies do not have the funds to follow through on costly clinical trials to demonstrate the safety and efficacy of emerging products in humans. Additional federal support may help ensure that new products reach the patients who need them. The bill would intensify efforts to assist small manufacturers in conducting end-stage clinical trials on qualified infectious disease products, including by awarding grants for such clinical trials.

Research and Development Tax Credit

-Allows manufacturers of infectious disease products to take a tax credit equal to 50% of the product’s research expenses for the taxable year.

Manufacturing Facilities Investment Tax Credit

-Provides a tax credit of 20% for a facility that is used for manufacturing, distributing, or for research and development of an infectious diseases product.

Clinical Trial Guidelines for Antibiotic Drugs

-Requires the FDA to issue guidelines for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat resistant pathogens, bacterial otitis media, and acute exacerbation of chronic bronchitis.

ELIGIBLE PRODUCTS

The bill defines a "qualified infectious disease product" as any antibiotic drug, antiviral, diagnostic test, or vaccine that is developed for the purpose of treating, detecting, preventing, or identifying an infectious pathogen identified by the Commission on Infectious Diseases Product Development.

The incentives will be immediately available to infectious diseases products addressing the following issues:

-Community-acquired methiciliin-resistant staphylococcus areus (CA-MRSA). There have been multiple incidents of healthy, young athletes acquiring untreatable CA-MRSA.

-Life-threatening gram negative bacteria, including E.coli and acinetobacter. At least 2 dozen soldiers have returned home from Iraq with the latter and there is only one antibiotic to treat it.

-Influenza.

-Extensively drug-resistant tuberculosis (XDR-TB). Recent research reports worldwide emergence of XDR-TB, which renders patients virtually untreatable with available drugs.

-Additional infectious pathogens may be identified by the Secretary of Health and Human Services (HHS), in concurrence with infectious disease clinicians. The Commission will later name additional qualified products.

INDEPENDENT COMMISSION

The bill establishes the Commission on Infectious Diseases Product Development. The Commission is required to identify the most dangerous infectious disease pathogens that are or are likely to become a danger to public health. The Commission will provide an annual report to Congress, the President, and the Secretary of Health and Human Services (HHS) on its findings, conclusions, and recommendations, including an updated list of emerging infectious pathogens as well as a continual assessment of barriers to financing infectious diseases R&D. The Commission's first annual report will address the potential benefits of medical liability relief to infectious disease R&D.

The Commission will be comprised of 19 voting members appointed by the President; 12 members to be appointed from among the leading representatives of the infectious disease medical, research, pharmaceutical, and biological communities, 7 members from the general public; additional nonvoting members shall be appointed from leading federal health agencies.