By James DeGiulio --
Earlier this year, we reported on the fading interest among larger pharmaceutical companies in developing new antibiotics, despite drug-resistant bacteria representing a serious public health issue (see "Increase in Drug-Resistant Bacteria Creating Need for New Antibiotics"). On October 19, Senators Richard Blumenthal (D-CT) (at right) and Bob Corker (R-TN) (below left) introduced the Generating Antibiotic Incentives Now Act of 2011 (S. 1734), a bipartisan bill designed to spur development of new drugs effective against antibiotic resistant bacteria -- drugs that will be critical as the prevalence of bacterial strains resistant to current gold standard antibiotics continue to spread.
Antibiotic-resistant infections are on the rise in the U.S., particularly affecting children and the elderly. Also vulnerable are troops returning from Iraq and Afghanistan, as many of them have been exposed to new, highly-resistant, and contagious strains of bacteria, such as Acinetobacter. Eighty-nine percent of infections caused by mutant strains of Acinetobacter are resistant to at least three classes of antibiotics, and 15% are resistant to all forms of treatment. Even common strains are reaching critical levels of resistance. For example, nearly 50% of Staph infections are resistant to most antibiotics.
Economically, antibiotic resistance leads to $26 billion in extra costs annually to the U.S. health care system. However, despite the clear need, only two of the top six drugmakers are currently developing antibiotics. Antibiotics do not present attractive targets for drug development, for even if reaching the market, they are not large revenue sources. Antibiotics are only used for a limited time, thus presenting only a discrete sales opportunity. The top five antibiotics earned a relatively modest combined $6 billion in 2010 in the U.S. Furthermore, doctors are often advised to limit antibiotic treatment because of concerns that overuse can spur resistance.
The GAIN Act will provide incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process so that pioneering infectious disease products can reach patients. The bill instructs the Secretary of the Department of Health and Human Services (HHS) to create regulations to implement this legislation. The legislation sets out specific definitions of which "infectious disease products" will qualify for GAIN eligibility. If a product is determined to fall within the recognized category, the HHS Secretary will have the discretion to give it priority review. The bill also proposes to extend the exclusivity period for these products by five years. This extended period will be in addition to any extension for pediatric exclusivity. The legislation would not apply to supplement applications for presently approved drugs, a change that results in a new indication, or a modification to a structure of the product. The bill would also give a product an extended 6 months of exclusivity if the sponsor or manufacturer identifies a companion diagnostic test.
The legislation further asks the Comptroller General to conduct a study on the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. It would also instruct the Secretary to review guidelines for conducting clinical trials for antibiotics drugs and revise them as necessary.
Senator Corker noted that federal dollars would not be required to provide these meaningful market incentives to antibiotic developers through their legislation. Senators Blumenthal and Corker were joined by co-sponsors Senators Bennet (D-CO), Hatch (R-UT), Casey (D-PA), and Alexander (R-TN). The bill was referred to the Senate Health, Education, Labor and Pensions (HELP) Committee. The companion House Bill, H.R. 2182, was introduced back on June 15th, by Phil Gingrey (R-GA) and Diana DeGette (D-CO), and has nineteen co-sponsors. The House bill was referred to the House Energy and Commerce Committee, Subcommittee on Health.
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