Over-the-Counter Medicines: Tracing Back to a History
The history of ‘over-the-counter’ medicines has been no less than an uphill battle. The famous Rose case that led to the decision of the House of Lords in 1704 stated that apothecaries could prescribe and dispense medicines. This breaks the monopoly of the College of Physicians. Over time, this medicine type continued to be generally available in Britain until 1860, when prescription-only medicines came into play, keeping in mind the safety of drug usage.
The development of over-the-counter drugs in the USA has a history deeply rooted in the lack of regulation in the early stage, which evolved through various legislative changes and actions taken by the US Food and Drug Administration to ensure effectiveness and safety.
Initially, most of the drugs were available without a prescription, and the chances of selling potentially harmful substances as medicines were higher at that time. Gradually, with the Food, Drug, & Cosmetic (FD&C) Act of 1938 and subsequent amendments like the Durham-Humphreys Amendment of 1951, a framework was established to distinguish between OTC and prescription drugs.
This small study by The CEO Views has explored and contributed to the understanding of OTC drugs and how the FDA (Food and Drug Administration) played a remarkable role in their development.
Understanding Over-the-Counter Medicines
As pronounced by the FDA (Food and Drug Administration), over-the-counter medicines (OTC) or nonprescription medicines can be bought without a prescription. These medicines are safe and effective to consume if one follows the directions on the label or as directed by one’s healthcare professional. These FDA drugs include pain relievers and fever reducers, and consumers can get details of their safe usage by going through the Food and Drug Administration‘s published brochures, articles, fact sheets, checklists, printed public service announcements, and other educational resources.
OTC Drug Review Process and the Monograph System
Among all the FDA drugs, over-the-counter drugs have had a longer history of review and amendments. Nonprescription drugs can be brought to the US market through two regulatory pathways – the drug application process and the over-the-counter drug review, or the OTC drug monograph process.
On March 27, 2020, the CARES Act (the Coronavirus Aid, Relief, and Economic Security Act, P.L. 116-136) added section 505G to the Federal FD&C Act. This Section reforms and advances the OTC monograph drugs regulation framework. Under Section 505G, OTC monograph drugs can be marketed without an approved drug application if they meet the regulatory requirements.
According to the FDA (Food and Drug Administration), the monograph system states certain conditions, such as uses, active ingredients, labelling, routes of administration, and testing, under which an over-the-counter drug in a given therapeutic category is generally recognized as safe and effective (GRASE) for use.
The process under Section 505G(b) states that the Food and Drug Administration has the authority to direct an administrative order, using which it can add, remove, or change (GRASE) conditions for an OTC drug monograph.
Administrative Order Process
The administrative order process can either be initiated by an industry (drug development, processing, manufacturing, and marketing) or the FDA (Food and Drug Administration).
FDA-Launched Order
The FDA initiates a proposed order, for which the public is given at least 45 days to submit their feedback. After reviewing and considering their feedback, the Food and Drug Administration issues a final order, the final over-the-counter monograph. The final order is subject to an administrative hearing, dispute resolution, and judicial review.
Industry-Issued Order
In this review process, an industry can request the FDA to issue an administrative order by submitting an OTC monograph order request (OMOR). After review, the FDA will determine if the OMOR is acceptable for filing. If found acceptable, it will issue a proposed order. The latter processes are the same as the FDA-initiated administrative order issuing process.
Ensuring the Safety of OTC Products: An FDA Approach
The FDA (Food and Drug Administration) strives to ensure that over-the-counter drugs, like all other FDA drugs, are safe to consume. It has enforced regulations to ensure that OTC drugs are safe and the labels are easily understood by the users. To achieve that, all OTC products must meet FDA effectiveness, quality, and safety standards. Although they are easily obtained and do not require a prescription, they are medicines and have risks associated with them. Below are some of the safety standards issued by the Food and Drug Administration that one must consider before consuming OTC products-
- Just by using the labels on the over-the-counter products, consumers can be able to decide if the product is safe for them to use, understand warnings, and follow usage directions.
- They must be FDA-approved to ensure they are safe and effective.
Examples of Some OTC Products Available in the Market
There are many over-the-counter products available in the market. These include-
- Fever reducers
- Pain relievers
- Antiperspirants
- Cough & cold medicines
- Emergency contraceptives
- Medicines for heartburn
- Hair re-growth solutions
- Weight loss medicine
- Sunscreens
- Toothpastes
