Health organizations seek stronger labels for ADAPT drugs

More than 30 national organizations, including the American Medical Association, the Infectious Diseases Society of America and Pew Charitable Trusts, are calling on members of Congress to strengthen labeling requirements for drugs approved under the Antibiotic Development to Advance Patient Treatment, or ADAPT, Act, providing stronger indications that the drugs are approved for limited populations and should be used judiciously.

In a letter to US Reps. Phil Gingrey, MD, R-Ga., and Gene Green, D-Texas, who introduced the legislation in December, the organizations supported the act, which will speed up the approval antibacterial and antifungal drugs for specific patient populations with an unmet medical need, allowing them to be approved based upon smaller clinical trials. As such, the drugs should have strong visual cues on the labels to remind providers to prescribe appropriately, the letter stated.

“Judicious use of drugs approved under this pathway is critical for optimal patient care and public health efforts to protect against the development of resistance,” the organizations wrote. “We appreciate the ADAPT’s provisions aimed at this goal, including the requirement that the labeling of drugs approved under this pathway state that they are approved for a limited population. We recommend strengthening this provision by requiring the label to include a prominently placed visual element, such as a logo, to clearly indicate to the health care community that these drugs are approved for a limited population and must be used prudently.”

The organizations provided examples in which the act is necessary to combat resistant infections, which affect more than 2 million people in the United States each year and kill approximately 23,000, according to the CDC. In particular, it cited an incident in 2011 in which carbapenem-resistant Klebsiella pneumoniae infected 17 patients at the NIH’s Clinical Center in Bethesda, Md., killing six.

Populations at greatest risk for life-threatening infections from so-called “superbugs” include immunocompromised individuals, children, heterosexual women, combat soldiers and HIV patients, the letter stated.