The Food and Drug Administration (FDA) is the regulatory body for pharmaceutical and healthcare industry in the USA. The FDA has developed a new strategy to get real-time information and updates pertaining to the manufacture, sale, and approval of novel antibiotics and anti-fungal medications. This information shall be available to all healthcare providers (doctors, nurses, and pharmacists). The main objective of FDA is to combat the growing menace of antimicrobial resistance.
The regulatory authority FDA has created a special website that provides real-time information about how a special drug can be used to combat specific bacterial or fungal infections. This information is necessary to tackle the growing menace of medical negligence and non-optimized medications; the implications of these limitations have burdened the current healthcare system by more than billion dollars annually. The proliferation of resistant bacteria can be effectively tackled by healthcare professionals with this real-time information, thereby providing better patient outcomes.
One of the biggest problems of modern medications is the growing resistance to antibiotics. While concerted efforts are being made to develop new therapeutic drugs for various ailments, the use of antibiotics cannot be halted at this stage; however, medical doctors now prescribe limited doses of antibiotics to livestock as the problem of antimicrobial resistance is more severe in these subjects. The FDA has also implemented new guidelines on antibiotic use to improve patience care.
In a candid interview with Scott Gottlieb, M.D (erstwhile FDA Commissioner), we received the following feedback: most doctors have to tackle patients with critical ailments. To cure such patients, the doctor has to exactly identify the pathogen that is causing critical ailment in the patient. Moreover, the doctor has to assess comprehensively how defiant is the pathogen to various treatments.
A general diagnosis means that a doctor may prescribe a medication that is combated and resisted strongly by the bacterial or fungal pathogen. Such a situation does not do any good to improve the patients’ condition, and we cannot ignore the broader consequences of such situations as they can metamorphose into public health problems.
Under conventional treatment modality, the individual’s drug labeling had to be combined with the results of susceptibility testing; the process was quite lengthy and took a battery of tests for identification and confirmation.
A more centralized approach to tackle this issue of poor diagnosis and prognosis, FDA authorities have come up with a more centralized approach. The process had improved tremendously with this new tool; the efficiency of accurate diagnosis and prognosis has increased remarkably as healthcare providers are abreast with real-time information about latest drugs and medications.
In order to identify an antibacterial or antifungal drug that is most effective to treat infection in a patient, the FDA authorities have compulsorily asked physicians to perform antimicrobial susceptibility test (AST). The results of AST tests must be considered before prescribing any drug.
The criteria for these tests are as follows: “breakpoints” or “susceptibility test interpretive criteria. With these criteria, a physician has to evaluate the susceptibility of antibacterial/antifungal drugs to specific bacteria or fungi. The number of bacteria and fungi changes in the patients’ body over a period. With this changing trend, their susceptibility also decreases with respect to certain drugs. Breakpoints should be updated to take into account these occurrences.
The erstwhile conventional approach was as follows: the new breakpoint information was provided by the manufacturer of each drug in the drug label; each of these drug labels was reviewed and introduced into the market only after receiving approval from FDA. This process had to be accurately on a case-by-case basis. After receiving approval for revised drug labeling, the AST results also had to be updated and incorporated in the drug labeling. Owing to this process, there was an unnecessary delay in disseminating information to healthcare providers. In each case, the drug and device labeling had to be changed whenever there was a sharp change in breakpoints.
Because the US Congress updated the 21st Century Cure Act, the FDA could come up with this new approach: the breakpoints can now be updated for multiple drugs with same active ingredient; moreover, the information could be shared vividly through a dedicated website designed by the FDA. Thus, healthcare providers can now access all the FDA-recognized breakpoints on the online channel. Although the breakpoints are determined by the Standard-Development Organization, the FDA is the final regulatory authority that reviews and leverages their work. The FDA agrees as to whether they are appropriate for commercial use. Based on the review provided by the FDA, the standard can be accepted partially or completely. Furthermore, alternative breakthroughs can be established with the review of FDA. If companies disagree strongly with any of the recognized standards, they have full authority to supply data that can authenticate alternative breakpoints.
The breakpoint information is presented on the webpage of FDA. All drug manufacturers now have to update each drug labeling with respect to the breaking information updates. As the process has shifted, it has become automated and the previous time-consuming process of continuous updates has been overthrown. In other words, the process of drug and device labeling has become more efficient and less time-consuming. Thus, the responsibility of drug manufacturers and AST device developers has also reduced tremendously.
