The increase in health care costs in the United States and the emergence of safer and more effective OTC have prompted patients to treat their diseases themselves, which in the past had to resort to professional medical care. This trend increases the chances of obtaining previous prescription drugs, because some of these prescription drugs have been included in the scope of over-the-counter drugs. These over-the-counter drugs provide consumers with wider choices and opportunities.
The first major federal law to regulate drugs in the United States was the Federal Food and Drug Law of 1906, but it was not until the Federal Food, Drug and Cosmetic Law of 1938 that the safety of drugs was legally limited. The legislation of this new law has been under consideration since 1933. More than 65,438+000 people died, many of them children, just because people used this newly sold sulfanilamide mixed with toxic solvent ethylene glycol. This incident eventually led to the formation of the law. The Federal Food, Drug and Cosmetic Act of 1938 requires that all new drug products put on the market after 1938 should be proved to be safe for human use before being sold. According to the requirements commonly called original clauses, products put on the market before 1938 are not subject to NDA clauses. However, some OTC drugs currently on sale, such as aspirin, are still affected by this clause. In addition, when reviewing OTC drugs, FDA has reviewed the safety, effectiveness and labeling of all OTC drugs, no matter when they are sold. In the whole process of new drug application in the United States, prescription drugs can be reclassified as OTC drugs and their status as new drugs can be retained. You can also directly approve new drug applications for OTC drugs (without reclassification), such as isotropic acid 2OOmg (dosage never used in the prescription). When a new drug is used by many patients for many years, it can be considered as safe and effective. OTC drugs approved by FDA can also be fully recognized. After the review, all OTC drugs that have not been approved as new drugs will be classified as OTC drug monographs (see "Meaning of OTC monographs" for details).
Before 1972 started the OTC drug review, none of the subordinate units of FDA specifically handled the OTC drugs currently sold. Initially, FDA officials helped the advisory review team review the ingredients, labels and warnings of OTC drugs sold, and published the resulting federal documents. From 65438 to 0977, a larger and more formal institution was established, including the OTC Drug Evaluation Department of the Drug Evaluation Research Center (CDER). However, at that time, most of the problems related to new drugs (including reclassification and application) were handled by a new drug department of the Center for Drug Evaluation and Research instead of OTC drug department.
OTC Drug Evaluation Department was reorganized into OTC Drug Evaluation Office on 199 1. It enriches the work of the new drug evaluation department responsible for handling new drug applications and prescription drug conversion. It includes a monograph examiner, a medical examiner and a drug policy officer. They were assigned to raise the issue of OTC drugs at the same time, such as the conversion of prescription drugs to OTC drugs, new OTC drugs, international coordination and necessary monitoring of health care expenditure.
2. Since 198 1 the last OTC drug advisory group was dissolved, there has been no special advisory group to conduct routine inspection on OTC issues. Sometimes, OTC ingredients are reviewed by a standing prescription drug care team.
199 1 year, FDA announced the establishment of OTC Drug Advisory Committee to review and evaluate the safety and effectiveness of OTC drugs, and to serve as a place to exchange opinions when various prescription drugs are converted into OTC drugs. A core committee composed of 10 people with rich experience and professional knowledge was established, and all members are experts with rich knowledge in internal medicine, obstetrics and gynecology, dermatology, epidemiology, pharmacy, clinical pharmacology, pediatrics and related professional fields. When discussing a special topic, the core committee can absorb experts who have expertise in this issue from other FDA committees to participate in the discussion. For example, when considering topical preparations, you can invite a number of dermatologists. The new committee also includes a consumer representative and a non-voting industry liaison. 1992 12 held the first meeting to review the pharmaceutical effects of alcohol in OTC products and prescribe smaller doses of oral drugs.
In recent years, the US Food and Drug Administration (FDA) has made new regulations on OTC drug labeling in order to standardize the labeling of OTC drugs sold in the US market and reduce the abuse of OTC drugs. It is estimated that 170000 patients are hospitalized for OTC drug abuse every year, and the treatment cost is about 7.5 billion US dollars. The researchers found that half of OTC abuse incidents can be avoided by standardizing labels and strengthening drug guidance to consumers. Regulation: The basic contents of all OTC drugs must appear on the label in order, and the text should be easy to understand. The contents that drugs must appear on the label are: active ingredients; Usage; Precautions; Medication guidance; Adverse drug reactions and other information. The new law stipulates six different types of labels, which manufacturers can choose freely according to the shape and size of their products. This regulation will have a trial period of two years. The FDA will also implement a program aimed at enhancing consumers' knowledge of taking OTC drugs, especially for children, people who need special care and the elderly. This work will be jointly undertaken by OTC Pharmaceutical Industry Association and National Pharmaceutical Chain Store Association.