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Public Statements

Food and Drug Administration Safety and Innovation Act of 2012 -- Continued

Floor Speech

Location: Washington, DC


Ms. MIKULSKI. Madam President, I come to the floor to talk about antibiotic resistance, a public health threat to Americans across the country. I have heard first hand from hospitals, health care providers, public health officials, scientists, and life sciences companies in Maryland that we need new antibiotics in our arsenal. Bacteria, like viruses, are crafty and constantly evolving to thwart existing treatments. Everyday, Americans are infected by multi-drug resistant microbes.

In most instances, antibiotics, much like vaccines, are not meant to be used everyday to treat a condition for months, years, or a lifetime. You use antibiotics sparingly, so you do not build up resistance. Yet, drug development for these infectious pathogens can take just as long as developing any other drug whether it is for HIV, heart disease, or cancer. Because antibiotics are used for a short period of time, they are not really profitable to the companies investing the time and money to develop the product. There are not many small start-up companies or big pharma companies that want to take the risk. Research and development costs hundreds of millions of dollars, so these companies are reluctant to invest in a safe and effective drug that doctors are told to use sparingly. Bottom line, developing a next generation Viagra pill is far more profitable for shareholders.

So, House and Senate Republicans and Democrats came together and worked on a bipartisan bicameral solution to incent development of drugs to treat serious or life-threatening bacterial infections. We need to get more antibiotics in the drug development pipeline. We are running out of antibiotics to treat MRSA, tuberculosis, acute pelvic infections, complicated urinary tract infections, or complicated intra-abdominal infections. There are many anaerobic gram negative and anaerobic gram positive bacteria that are fatal, cause lifelong injuries, increase the transmission of HIV and other sexually transmitted diseases, or affect the reproductive and gastrointestinal tracts.

Title VIII of our bill, provides incentives for the development of antibiotics to treat serious or life-threatening infections, including infections where tolerance and resistance to existing antibiotics make them ineffective. We need to clear up infections that can cause poor outcomes for patients or negatively impact the public's health.

This bill will increase exclusivity for manufacturers that invest the time as well as the research and development dollars to bring new antibiotics to the market that knock out infections that cause pre-term labor or target bacterial infections in patients with unmet needs.


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