A series of outbreaks of antibiotic-resistant "superbugs" have led some medical experts, government agencies and major pharmaceutical companies to push for a fast-track process to approve new antibiotics for use, raising safety concerns among some critics who fear drugs with only narrow testing may get overprescribed and potentially harm patients, drug safety and overall public health.
As reported by the New York Times:
The need for new antibiotics is so urgent, supporters of an overhaul say, that lengthy studies involving hundreds or thousands of patients should be waived in favor of directly testing such drugs in very sick patients. Influential lawmakers have said they are prepared to support legislation that allows for faster testing.
The Health and Human Services Department last month announced an agreement under which it will pay $40 million to a major drug maker, GlaxoSmithKline, to help it develop medications to combat antibiotic resistance and biological agents that terrorists might use. Under the plan, the federal government could give the drug company as much as $200 million over the next five years.
“We are facing a huge crisis worldwide not having an antibiotics pipeline,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration. “It is bad now, and the infectious disease docs are frantic. But what is worse is the thought of where we will be five to 10 years from now.”
In an effort to prevent the overprescription of narrowly tested drugs, some agencies have suggested specifying their terms of use to very sick patients, but critics fear that the drugs will still be given to patients who do not need them and pose additional threats to public health and safety:
[Critics] say they worry that the new medications, without the more comprehensive testing, could then be used on healthier patients who do not necessarily need them.
“There is really no way of knowing how these drugs are going to perform,” said Dr. John H. Powers, a former F.D.A. antibiotics reviewer who is now an associate professor at George Washington University in Washington.
The overuse of antibiotics in people and animals, often for conditions for which the drugs are ineffective or not needed, is seen as a driving force in the development of resistant bacteria.
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