Monday, September 23, 2013

More than 40 percent of the antibiotics released between 1980 and 2009 were withdrawn from the market for safety concerns, lack of effectiveness compared to existing drugs, and weak sales, according to the first study to evaluate the status of 30 years of antibiotic approvals by the U.S. Food and Drug Administration.

The study, released today in the Journal of Law, Medicine and Ethics, found that antibiotics were withdrawn from the market at a rate three times higher than other drugs released between 1980 and 2009.

“This study raises the question whether or not money would be better spent on higher quality antibiotics, rather than a larger quantity,” according to the author Kevin Outterson, JD, LLM, professor at Boston University School of Law and co-director of the Boston University Health Law Program.

Because antibiotic use triggers bacteria to become resistant to the drug, Outterson also questioned whether “approving a flood of new lower-quality antibiotics might actually trigger much higher levels of resistance.”

The US Centers for Disease Control reported last week that each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections.

The study, “Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the US, 1980-2009,” was funded by the Public Health Law Research (PHLR) program of the Robert Wood Johnson Foundation (RWJF).

Conservative use of existing antibiotics and the production of new antibiotics are two key strategies to combat the public health dangers associated with antibiotic resistant bacteria. Production of new antibiotics also allows physicians to replace existing drugs that may have been diminished by resistance.

The study finds that in the past 30 years, anti-infective drug approvals have remained fairly steady, but peaked in the 1990s with an increase in the number of HIV/AIDS-related antiretroviral drug approvals. Anti-infective drugs include antibiotics, antivirals and antiretrovirals, and antifungals. The study also finds that antibiotics were withdrawn at a rate far higher than was observed in non-antibiotic drugs (43 percent vs. 13 percent). The withdrawals were greatest for drugs approved between 1980 and 1984, and lowest for drugs approved between 1985 and 1989. Recent efforts in Congress and the FDA to prevent combat antibiotic resistance have encouraged a fast-track to market, which focuses on introducing a large number of antibiotic drugs quickly.

The findings published today suggest that public health may be better served if newly introduced drugs are higher quality – with high clinical utility, discrete mechanisms of action, and narrow spectrums to delay resistance.

Of 111 anti-infective drugs released from 1980 to 2009, 61 were antibiotics, and 26 of those were withdrawn. Resistance did not appear to play a major part in these withdrawals.

This study was conducted by Outterson and his colleagues John Powers, MD, FACP, FIDSA, associate clinical professor of medicine at George Washington University School of Medicine, Enrique Seoane-Vazquez, PhD, associate professor at the Massachusetts College of Pharmacy and Health Services, Rosa Rodriquez-Monguio, PhD, associate professor at the University of Massachusetts, Amherst, and Aaron Kesselheim, MD, JD, MPH, assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School.