These days, it is becoming increasingly common for prescription drugs to switch to over-the-counter (OTC) status, no longer requiring a prescription from a doctor. The process is highly regulated and involves rigorous science to ensure all OTC medications are safe and effective. Drug developers want their products to move from prescription to OTC to increase both patient access and sales. This is a win-win for both consumers and drug developers.
Going Rx-to-OTC is a rigorous process
It’s not easy for drugs to switch their status from prescription to OTC, nor should it be. Considering the potential harm they can cause, government regulations are necessary to keep people safe. While all drugs, prescription and non-prescription, must undergo rigorous testing before they receive government approval, switching from being a controlled substance to an uncontrolled one also requires extensive oversight in the form of three major considerations [2].
The first consideration is the risk versus the benefit of changing the drug’s classification. This is determined by ensuring that patients can safely achieve the intended medical result of the drug without doctors or pharmacists serving as intermediaries. While medications always come with potential side effects and risks, going from prescription to OTC means the risks of self-medicating with the drug are low. The potential for abuse, the possible negative drug interactions with other drugs, and the toxicity must all be minimal at the most. It also means patients are able to self-diagnose the condition based on the information on the drug’s label.
Switching to OTC also involves following the necessary labeling standards. An OTC drug’s label must use clear, easy-to-understand language regarding uses, administration, and dosage. On top of that, it must include its active ingredients, inactive ingredients, storage instructions, and warnings about potential risks or side effects. In other words, OTC drug labels must state all need-to-know information directly on the packaging.
Lastly, the drug indications on the OTC label must be similar to its prescription indications. That being said, patients should still be able to self-diagnose with ease and accuracy. For example, patients with a non-recurring headache can diagnose themselves with an acute headache and buy OTC acetaminophen to relieve the pain without having to talk to a doctor.
Drugs must meet all of these criteria, monitored by the government, before they can officially switch from prescription to OTC. The process involves extensive clinical trials and oversight.
Examples of Rx-to-OTC products
Many medications that are now OTC used to be prescription-only. Once they went through the elaborate process and were deemed OTC-friendly, they made the switch.
For example, in earlier years, patients needed a prescription for wound-care medications. Now, most of them are available OTC, including topical antibiotics and antiseptics. Many allergy medications used to require a prescription as well. A prime example is Claritin (loratadine). Before its patent ran out in 2002, patients needed a prescription from a doctor to take it. Flonase nasal spray is another example of an allergy medication that made the switch from prescription to OTC, this one in 2015.
Most importantly, these medical products were able to make the switch to OTC because they were deemed safe for patients to self-treat. The possibility of misusing things like wound-care or allergy medications is low. Also, they don’t present the possibility of addiction. Given the safety of the drugs, their developers likely saw an opportunity to increase profits. OTC drugs are more accessible and thus patients tend to buy them more frequently.
Some medical devices have also switched their status from prescription to OTC. Laser hair removal once was a treatment patients could only get in a salon from a licensed professional. Now there are government-approved laser hair removal devices that allow us to safely do it at home [3]. Hair growth products, such as the government-approved minoxidil (commonly known by the brand name Rogaine), are also available OTC where they once were only available by prescription.
These are just a few examples of some of the once-prescription drugs and medical devices that are now available OTC. Given that all of these products are used for self-treatable medical issues and have demonstrated their safety, it makes sense that they no longer require a prescription. Still, as the process of changing the status of a drug or medical product is lengthy and arduous, not many shifts are made each year. In 2020, for instance, only five drugs made the switch, and in 2018 and 2019, no drugs did [4].
One of the major hold-ups when switching from prescription to OTC is that governments may require additional studies showing the drug or medical device is safe and effective without supervision from a healthcare professional. Research tends to be costly and time-consuming, between the organization, the recruitment, and the study itself. This is where CROs like ICON can step in to help sponsors navigate those changes quickly and professionally, as CROs are well-versed in the in’s and out’s of government drug regulation.
Benefits of OTC drugs
Consumers, medical professionals, drug manufacturers, and health insurance companies all benefit from drugs moving to OTC status. When consumers gain OTC access to a widely-used medication, it reduces the pressure on the medical system at large.
Consumers have a lot to gain when a prescription moves to OTC. Ease of access is the primary one. Having to go to the doctor for an easily self-diagnosable ailment is a waste of time and money, but it’s also a matter of comfort. When a person is not feeling well, the best thing to do is treat the issue as soon as possible. OTC medications make it possible to get relief from non-serious issues a lot faster.
When a drug’s status moves from prescription to OTC, the cost decreases. A lot of this has to do with the fact that drugs commonly switch to non-prescription when their patents run out, so cheaper generic options then become available.
Medical professionals, drug manufacturers, and health insurance companies also benefit from prescription drugs moving to OTC status. It frees up time for both doctors and pharmacists to deal with more pressing concerns, as drug manufacturers are required to label OTC products with specific information geared for safe self-treatment.
For drug manufacturers, drugs going OTC allows them more leeway in advertising, often equating to better profits. Using advertising to help educate consumers about a drug gives consumers confidence in their buying. Knows exactly what a drug is for and how it will help make customers more likely to buy it.
Additionally, when drug manufacturers increase their profits, they can invest more money into the continued development of new drugs and medical technology. This is good for the manufacturer, the healthcare research industry at large, and consumers. Health insurance companies’ costs can decrease when drugs move to OTC, as they no longer have to cover those medications in their premiums.
How a CRO can support drug developers in the move from Rx to OTC
CROs exist to assist drug developers in a variety of ways. First and foremost, CROs help drug developers get their medications and medical devices approved. However, government approval is not the only process drug developers have to deal with. Switching a drug’s legal classification is another significant process they face. CROs provide management services to drug developers, which include helping them change the legal status of a drug or device.
As mentioned, switching a medicine from Rx to OTC can involve additional research to confirm its safety and efficacy. CROs can facilitate this process the same way they do for early clinical trials, organizing everything from study design to ensuring the sponsor is meeting government regulations.
The regulatory concerns involved in switching to OTC require jumping through numerous government hoops [5]. Hold-ups tend to be expensive, delaying the introduction of a prescription medication to the OTC market. CROs can be enormously helpful in this regard, through things like project management, investigator meetings, data management, and medical writing.
Staying on the topic of regulations, the labeling requirements of OTC drugs may seem straightforward, but nothing in the healthcare industry is easy. Putting that work in the hands of a trusted CRO can save time and money by avoiding mistakes along the way.
Commonly, the goal of switching from prescription to OTC involves maintaining or growing profits. The extensive experience and knowledge of many CROs involving consumer behavior allow them to help with the commercial side of switching a drug’s legal status. Building effective marketing and sales strategies are vital when a drug moves to OTC. Doctors prescribing a drug to patients is much different than a consumer choosing to purchase an OTC drug on their own.
Drug developers tend to be most successful when they focus on what they’re best at: scientific research. Outsourcing to a CRO during the process of moving a drug or device from prescription to OTC can then increase their potential for success, both scientifically and commercially, handing over the responsibilities of managing additional drug trials and new sale strategies. In particular, ICON has significant experience and expertise in helping sponsors figure out the best way to transition a drug or device from being regulated pharmaceutical product to OTC use.
References
1. https://www.fdareview.org/issues/history-of-federal-regulation-1902-present/
2. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/now-available-without-prescription
3. https://hairbuffmama.com/fda-cleared-home-ipl-hair-removal/
4. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/prescription-over-counter-otc-switch-list
5. http://www.hpra.ie/homepage/medicines/regulatory-information/medicines-authorisation/legal-supply-status-and-reclassification
Jess Lakritz 