FDA Enters Withdrawal: Agency Must Pursue Limits on Penicillins and Tetracyclines

Yesterday, a federal magistrate ordered the Food and Drug Administration (FDA) to move ahead with a decades-old effort to withdraw approvals for several uses of antibiotics considered “critically important” to human health by the World Health Organization.  This is a solid win for public health advocates and comes as FDA has proven unwilling to take seriously the threat of antibiotic resistance.

In 1977, FDA proposed withdrawing approvals for the use of penicillin antibiotics for growth promotion and the use of several tetracycline antibiotics in animal feed.  Research showed then—more than three decades ago—that these uses were likely to select for antibiotic-resistant bacteria that can infect humans.  Unfortunately, lobbyists for the pharmaceutical and animal agricultural industries persuaded Congress to delay the restrictions pending additional research.  FDA did more research but took no further action for the next 34 years. Read More >

WHO Raises H1N1 (Swine Flu) Pandemic Level to Highest Point

Dr. Margaret Chan

Dr. Margaret Chan

The World Health Organization (WHO) has decided to raise the level of influenza pademica lert from phase 5 to phase 6, the highest level. The level was heightened, according to WHO, based on “available evidence and expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met.”

“The world is now at the start of the 2009 influenza pandemic,” WGO Director-General Dr. Margaret Chan said in a statement to the press today. “We are in the earliest days of the pandemic. The virus is spreading under a close and careful watch. No previous pandemic has been detected so early or watched so closely, in real-time, right at the very beginning.”

Dr. Chan emphasized that many, but not all, severe cases have occurred in people with underlying chronic conditions. “At the same time, it is important to note that around one third to half of the severe and fatal infections are occurring in previously healthy young and middle-aged people.”

Despite the heightened level, WHO says it continues to recommend no travel restrictions or border closures.

The Changing Food Landscape and the FDA

Baltimore’s former health commissioner, Dr. Joshua Sharfstein, is making news as the new deputy director of the FDA, serving under the new commissioner, Dr. Margaret Hamburg. Hamburg and Sharfstein have pledged to reform the food safety system and encourage scientific exchange and better communication to the public.

In the New England Journal of Medicine, Hamburg and Sharfstein acknowledged the difficulty of decision-making at the FDA, often in the absence of complete information, and admitted that recent high profile contaminations (peanut butter, anyone?) have rightfully caused the public to question the agency.

This is certainly a daunting task, but Hamburg and Sharfstein seem ready for the challenge (see some background on them here).

Indeed, there are many aspects of the food system that advocates for public health, the environment, animal welfare and social justice have identified as areas in dire need of improvement. The FDA will have the authority to address some of these issues, but not all. Some recent articles have discussed complicating factors that may impact the safety of the nation’s food supply. Read More >

“Not If, When:” What We Can Learn From Latest Swine Flu Outbreak

The World Health Organization is poised to raise the pandemic threat level as a deadly strain of the swine virus shows no sign of slowing down, according to a latest Reuters report. The New York Times reports that the number of people killed by the virus has climbed to 149 in Mexico and 8 of the 20 confirmed cases in the U.S. were diagnosed in New York City.

Reuters says the change in threat levels would indicate that the virus has mutated to the point that it is being transmitted from person to person more easily. According to an earlier Reuters report the CDC’s early analysis determined the virus strain, which is designated H1N1 (similar to the “Spanish Flu” which killed tens of millions of people in the early 20th Century) contains DNA from swine, human and avian viruses.

Read More >