Newly enacted, IDSA-backed legislation aims to help “old” antibiotics gain new approvals from the Food and Drug Administration.
The legislation repeals components of a 1997 law that blocked antibiotics from receiving certain market exclusivity benefits that would have kept generic competitors off the market longer. That law was a blow to drugmakers’ incentive to develop these antibiotics. Under the new law, antibiotics approved before 1997 can get three years’ exclusivity if they are approved for a new indication. Antibiotics that had begun the approvals process but did not follow through once the 1997 law went into effect can get five years’ market exclusivity if the drug is approved. This fix puts these antibiotics on the same playing field as all other drug categories.
Although the legislation will apply to only a handful of drugs, IDSA has been backing the provision for some time as a way to raise awareness of the need for new incentives to develop antibiotics. (See IDSA’s Dec. 2007 letter to Sen. Edward Kennedy, Chairman of the Committee on Health, Education, Labor, and Pensions.)
In other news, the president has signed legislation that bolsters funding for the Center for Disease Control and Prevention’s (CDC) National Program for the Elimination of Tuberculosis and authorizes much-needed new research on TB prevention and treatment at the National Institutes of Health and CDC. The Comprehensive Tuberculosis Act Elimination Act of 2008 was endorsed by IDSA, HIVMA, and several other organizations.
Other advocacy efforts include:
- The House of Representatives passed a resolution supporting increased public and private commitment to prioritize prevention and public health for all people in the
United States. IDSA and 157 other organizations signed a letter supporting the nonbinding resolution, H. Res. 1381.
- A bill introduced in the House of Representatives would improve the nation’s surveillance and reporting for diseases and conditions and expand resources for several existing CDC programs. IDSA has endorsed the bill, the National Integrated Public Health Surveillance Systems and Reportable Conditions Act (H.R. 6905)
- The House of Representatives approved a resolution highlighting the problems associated with methicillin-resistant Staphylococcus aureus (MRSA). The intent of the resolution (H. Res. 988) is to raise greater awareness about resistant infections toward the goal of enacting the IDSA-backed Strategies To Address Antimicrobial Resistance (STAAR) Act next year.
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