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A proposed federal law to stimulate more research into and development of new antibiotic drugs appears to be gaining momentum and could win congressional approval in the next month or two, according to the bill's sponsors. Without new drug development, deaths due to resistant infections will continue to rise.
The GAIN Act (Generating Antibiotics Incentives Now) attacks a couple of the problems that inhibit development of new antibiotics. It would extend by five years the 12-year patent protection for new antibiotics. This ability to exclusively produce and market a drug longer before competing with generics can provide pharmaceutical companies a greater return on investment, making them more likely to invest in antibiotic research.
The act would also streamline the regulatory and approval process, now so burdensome and costly that many companies do not see such research as worth the investment. The act seeks to strike a reasonable balance between getting new infectious disease products to patients quicker, while assuring their safety and documenting side effects.
Among the sponsors is U.S. Sen. Richard Blumenthal, a Connecticut Democrat. Joining Sen. Blumenthal in introducing the legislation last October was Sen. Bob Corker, R-Tenn. The House version also has bipartisan sponsorship; Rep. Diana DeGette, D-Colo., and Rep. Phil Gingrey, R-Ga.
"The United States is facing a public health crisis in the near future if we are unable to encourage new drug development," said Rep. Gingrey.
That is not an overstatement.
Public health officials are witnessing an alarming increase in the number of patients acquiring infections resistance to treatment by existing drugs. Yet at a time when a new generation of antibiotics is necessary to give doctors more treatment options, only three new antibiotic drugs have gained U.S. Food and Drug Administration approval since 2007.
Antibiotic-resistant infections will cause about 90,000 deaths this year, disproportionately affecting children and the elderly and adding $26 billion in added costs each year to the U.S. health care system. Antibiotic-resistant strains now account for nearly half of Staph infections. Between 1999 and 2005, resistant MRSA infection-related hospitalizations doubled to 278,000, with a 300 percent increase seen in neonatal intensive care units, according to the Centers for Disease Control and Prevention.
From an industry perspective, investing in antibiotic research is often not good business. A patient receives antibiotics for only a few days, while drugs to address ongoing problems such as high blood pressure or high levels of cholesterol are used by patients for years. That reality, combined with long clinical trials and eventual generic drug competition, has persuaded pharmaceutical companies to trim or abandon antibiotic research. Pfizer disbanded its antibacterial research unit in Groton last year.
Whether the GAIN Act is enough to reverse those trends is uncertain, but it is far better than inaction and the legislation deserves quick approval.