More than 30 organizations Wednesday called on Congress to ask for stronger labeling requirements on a bill that would allow antibiotics to be fast-tracked and used in a limited population of patients.
They recommended the addition of a visual element, such as a special logo, picture or color, which they said would make it easier for physicians and pharmacists to distinguish these drugs from existing antibiotics.
Rep. Phil Gingrey (R-Ga.) introduced the Antibiotic Development to Advance Patient Treatment, or ADAPT, Act in December 2013, an effort to address the growing public health threat of superbugs, strains of bacteria that are resistant to many of the available antibiotics on the market. The bill included safeguards—such as requirement of a prominent statement in the prescribing information that indicates the drug is for use in a “limited and specific population of patients,” and an ability of the health secretary to review marketing conditions—intended to ensure that the right patients get these fast-tracked medications.
In a letter sent Wednesday to Gingrey and Rep. Gene Green (D-Texas), one of nine senators who helped introduce the bill, the groups urged that a visual element would strengthen measures and help prevent misuse.
“We think it's critical to make it crystal clear to the healthcare community that drugs approved under this pathway must be used appropriately and for the population for which they are intended,” said Amanda Jezek, vice president of public policy and government relations for the Infectious Diseases Society of America. Because the medications would be approved faster, based on smaller clinical trials, there is greater risk associated with their use, she said.
“That risk can be tolerated in patients who cannot use existing drugs. But we don't want to see them used in patients with less serious infections because those patients don't need to be exposed to additional risk,” she said.
Mainly, though, the letter offered support for the ADAPT act, calling it critical legislation that provides a solution to an unmet medical need.
“Without such a pathway, we fear that the antibiotic research and development will continue to struggle, and that patients will continue dying without new treatments,” according to the letter.
The Infectious Diseases Society of America, American College of Surgeons, American Academy of Pediatrics, American College of Preventive Medicine, American Medical Association and Pew Charitable Trusts are just a few of more than 31 groups that cosigned the letter. The ADAPT legislation, which gained support of both Democratic and Republican representatives when introduced, is awaiting congressional review.
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