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Over-the-counter medicines (OTC)

OTC is better known as non-prescription medicine or over the counter drugs. All medications bought without a physician’s prescriptions are OTC.

Food and Drug Administration

The United States Department of Health and Human Services has a department known as FDA which stands for Food and Drug Administration. The purpose of FDA is to ensure the safety of the public health by reviewing and supervising products associated with cosmetics, medicines, vaccines, veterinary products, OTC’s, dietary supplements, and biopharmaceuticals.

Regulation of OTC by FDA

The United States distribution of medicine gets based on whether they are non-prescription or prescription. The Food and Drug Administration categorises an OTC or non-prescription drug safe for human consumption based on the descriptions, warnings and instructions on the label. All OTC medicines as of 1970 are subject to FDA reviews for safety and effectiveness. FDA is strict on the safety protocol for over-the-counter medication in comparison to prescription drugs.

The Center for Drug Evaluation and Research (CDER) from FDA, handles the review of OTC drugs. CDER’s department of Non-prescription Drugs has the core responsibility of reviewing OTC’s. Nonetheless, CDER seeks assistance from agencies and experts within the FDA. The child resistant closures that occur in numerous OTC products get governed by the U.S Consumer Product Safety Commission (CPSC).

OTC’s get regulated via OTC Drug Monographs by the FDA. The drug monographs have data concerning the adequate doses, ingredients, labelling, and formulations. The Monographs get updated through adding elements and labels. Any products that abide by the FDA monograph are clear for marketing. The ones that lack tangible clearance must go through a separate review before getting approval via the New Drug Approval System.

FDA and Effects on Pricing and Application
FDA Commissioner Scott Gottlieb confirms that increase in generic drugs will reduce the cost of medicines. According to Scott, the plan is to have about three manufacturers for every generic drug version. A single generic drug introduction will slightly reduce the prices. When the number doubles, the rate gets cut in half. When a third manufacturer gets introduced, the price will fall significantly.

The switch from original to generic drugs has had a considerable impact on the American health care economy. 20 billion dollars gets saved annually due to broader availability of over the counter medicines. The study by CHPA credits the 20 billion dollar savings to minimal doctor visits, reduced prescription costs, insurance costs, minimised the lost time during working hours, and reduced travel costs.

Related cases

Former Turing Pharmaceuticals AG leader, Martin Shkreli, earned him the rights to sell a drug called Daraprim. Martin sold the decades-old anti ineffective medicine at 750 dollars from a mere 14 dollars. Valeant Pharmaceuticals International Inc. Seized the low competition field by selling two treatments of Wilson’s disease. The company raised the cost to over 30 times its initial price.

The Food and Drug Administration approved to switch Nicorette gum from prescription to OTC status in February 1996. It further made a switch of nicotine patch products namely Nicotrol (July 1996) and NicoDerm CQ (August 1996). Other switches followed which include drugs like Prostep (December 1998) and Habitrol (November 1999). Years later in 2002, the FDA approved the first of its kind lozenge dosage form that contains nicotine known as Commit.

The regulation by FDA on governing medications is influential on both public health and pricing. By giving room for new generic medication, FDA creates a competitive market.

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