FDA plans to carry out a comprehensive reform of the modernization review of over-the-counter drugs

Source: DXY 2014-2-24 US FDA is proposing a comprehensive reform on how to regulate over-the-counter drugs, so as to respond more quickly to a new product's safety or proposed use information FDA has implemented over-the-counter drug laws and regulations for more than 40 years The rules do not require manufacturers to obtain over-the-counter drug approval, as long as the main ingredients are considered safe and effective before When new data on the potential side effects of a drug appear, the rules do not allow the FDA to respond quickly, the FDA said in a February 21 filing For example, based on the current understanding of acetaminophen induced liver injury, FDA tried to reduce the dosage of widely used products such as "enhanced" Tylenol from 500mg to 325mg "We think the dosage of this OTC drug should be changed, but it will take a long time, because the change can only be legislated," FDA spokesman Andrea Fischer said in an email statement In contrast, the FDA was able to act quickly to demand such a change in prescription pain drugs containing paracetamol FDA is seeking reform proposals for existing procedures to replace them with a new regulatory or statutory framework The FDA has scheduled a hearing on March 25 and 26 "This is a good sign that the FDA has recognized that its monitoring of OTC drugs is outdated and may pose a risk to patients," said Carmen balber, executive director of consumer protection She points out that most people don't consult their doctors in advance when taking over-the-counter drugs "When there is new information about drugs that are at risk for patient safety, patients need to know immediately, and FDA needs to be able to act quickly to require pharmaceutical companies to develop new drug labels," balber said Original link: http://