Some drugs we get as prescription only, others we can buy over the counter (OTC). We rarely think about the whole process that exists behind the products becoming available to us, or how long, arduous, and scandalous it may be. We also rarely concern ourselves with the differences in process that occur in different parts of the world. So today let’s take a look. Here are some basics of the US VS the EU when it comes to how drugs are approved.
The US and the EU have their own processes to have drugs approved, but not everything exists within regulation. Take the new cannabinoids market in the US, which includes the likes of delta-8 THC, THCV, HHC, and more. These compounds can be bought outside of dispensaries, and even online. Make sure to subscribe to The THC Weekly Newsletter for all the latest news and industry stories, as well as exclusive deals on flowers, vapes, edibles, and other products including Delta 8, Delta 9 THC, Delta-10 THC, THCO, THCV, THCP & HHC. You can find them in our “Best-of” lists!
The US VS EU for how drugs are approved: How does the US do it?
Most people should be aware of the organization, the FDA, or Food & Drug Administration. The FDA is a federal department that resides under the Department of Health and Human Services. The FDA regulates the food industry, the tobacco industry, all dietary supplements, all medicine – whether OTC or by prescription, vaccines, biopharmaceuticals, blood transfusions, all medical devices, anything that emits electromagnetic radiation, the cosmetics industry, animal food, and veterinary products.
In fact, the FDA is the only governing body for these things. And how much it does regulate these things can vary, often with strange laws attached. For example, the cosmetics industry isn’t actually regulated at all except for the use of ingredients for coloring. So though its under FDA regulation, there isn’t technically much of anything being regulated. Then there’s that pesky law that states that once a compound is an active ingredient in an approved medication, that it can no longer be marketed as a food or dietary supplement. Does this matter? Sure, it makes any supplement or food product containing CBD illegal federally.
The caveat to all this? States have their own rights, and these rights can go up against FDA (and general federal) policy. Take cannabis as the best example. According to the federal government, via the FDA and DEA, cannabis is federally illegal, yet 18 states (though it should be 19) have decided to implement recreational legalization policies that go against this. Realistically, states can do this with any drug if they can pass legislation within the state to change policy. Think of how Oregon legalized medical psychedelics and decriminalized recreational psychedelics use statewide. Or how Michigan and California are both floating bills for recreational psychedelics legalizations statewide.
The FDA might be the sole regulator, which holds all the power for US federal regulation on things like food, drugs, and medicines, but the ability for states to create their own functional systems at odds with the FDA, means that that regulation only holds if it matches state regulation.
The US VS EU for how drugs are approved: How does the EU do it?
The EU and the US federal government have one major similarity. They are similar in that they are both a federal entity that is composed of ‘states’ that are able to formulate their own laws. The US is one country with 50 states, whereas the EU is a union of 27 countries that all operate as their own countries, but under overall regulations set by the EU.
Regulation for the EU is a bit more complicated than the US, since the EU takes into consideration the desires of its member states, and must work to synchronize regulations that can cover 27 countries, without anyone getting mad. While the FDA was developed for consumer protection specifically, the European Commission was put together to integrate the commercial interests between member countries, while still allowing these independent countries to function on their own, and by their own rules.
The European Commission is an organization that “promotes the general interest of the EU by proposing and enforcing legislation as well as by implementing policies and the EU budget.” It is the sole organization that is responsible for creating proposals for new legislation, and it’s tasked with overseeing the implementation of any decision put in place by the European Parliament, or the Council of the EU, two other governing bodies.
It is made up of a team of commissioners, with each member country offering one representative. It is centered in Brussels, Belgium, and is a politically independent executive arm, meaning it doesn’t support any specific party from any specific country. This means that for any policy that needs to be set by the European Commission in regards to medical drugs and devices, it must do this within a network of many centralized and decentralized agencies throughout the entire EU. Contrary to this, if the FDA wants to set a policy, it doesn’t have to check with any individual state to do so, or consider the needs of any individual location.
So, how do the US and EU have their drugs approved?
In the end, the two locations don’t have widely differing ways of actually approving drugs, and the processes are pretty similar. Here is the general process, and how it differs between the US and EU for getting drugs approved.
– The application. In the US, an investigator who wants to study a compound must submit an application to the FDA for permission to conduct the desired trials, and as a part of this, to be able to transport the compound across states. For EU countries, the application is directed at the government of the particular country where trials are being held. If they are being held in more than one country, an application must be submitted in any country where the research would take place.
– Clinical Trials. This is when the drug is tested in a study for safety and efficacy. This step is exactly the same whether it’s the US or the EU trying to have drugs approved. It consists of these stages:
- Phase 0 and 1 Trials – A small number of healthy subjects are tested to understand pharmacology and dosing.
- Phase II – Hundreds of patients with the specific condition the medication is being made for, are tested to establish responses to different doses.
- Phase III – Hundreds or thousands of patients are tested to establish overall safety and efficacy.
– Emergency use and orphan drugs. In the US, an application for an ‘orphan drug’ indicates a special approval process for a drug that may help with a lesser-known illness that fewer than 200,000 patients in the US have. In the EU, an orphan drug application is for special consideration of a compound that could be useful for medical conditions that no more than one in 50,000 patients have yearly.
Along with this are emergency drug applications. In the US, an ‘emergency drug application’ (EIND) provides for a shorter application process in the interest of getting an approval in a life-threatening situation. In these instances, full approval of a final product is not necessary, as treatment can be initiated upon approval of the application. In the EU, the use of an emergency drug in a life-threatening situation can start as long as clinical trials for the drug are underway.
– Drug approval. The US and EU are very different when it comes to the part of actually having drugs approved. In the US, following clinical trials, a ‘new drug application’ is submitted to the FDA, and the FDA is tasked with making a judgement as to whether to approve the medication or not.
In the EU, it’s a bit more complicated at this step, with four possible avenues that are used depending on the kind of drug, and what the manufacturer prefers. These four options are:
- A centralized process through the (EMA) European Medicines Agency, for use with designated drugs. This process must be taken in some circumstances, like for HIV/AIDS medications, cancer treatments, drugs for neurodegenerative diseases, drugs for autoimmune diseases, and drugs for viral diseases.
- A process that occurs within a member state by applying to the relevant national agency within the specific country. These measures may be different than standard EMA requirements.
- Through mutual recognition, which allows a drug that has been approved in one country, to be applied for approval by another member state, or to the EMA for approval throughout the EU.
- A decentralized process in which applications are submit simultaneously within different countries in the EU for the same drug, by the same manufacturer. In the past this has been the most-traveled avenue for approval, and though these numbers go back a bit, in 2008, 1,400 applications came through this way, vs 100 through the centralized process.
A few things to be aware of
I think we know by now that there are tons of things to be wary of when it comes to big pharma and drugs. Here are some things to know between both the US and the EU about these processes.
- While these drugs merely fill a space where perhaps nothing existed, they are often treated as so detrimentally important that not all data collected is peer-reviewed, or released to the public, meaning the public is given approved medications, based on research which could be quite faulty.
- Pharmaceutical companies often pay for their own research, or pay for it to be done, creating a massive conflict of interest. Adding onto that, the governments often fund such research making the idea of being objective practically impossible.
- Supposedly, the FDA makes nonpublished data on new drug applications available online (begging the question of why its not just released to the public), whereas the EU’s EMA will not release such information, even if products are being based on the research.
- It has been proposed in both places to allow drugs to be released after Phase II trials, with surveillance kept on patients afterwards to ensure safety. This is meant to quicken necessary drugs to market, but the question should really be asked, if this is to the benefit of pharmaceutical companies, or to individuals, as these trials are literally there to establish safety, and there is a long track record of unsafe medications being recalled.
- And let’s remember, that one of the biggest pharma-induced travesties of today is the constant and growing opioid epidemic in the US and abroad. More relevant than it existing, is that it exists because of regulation by these governmental bodies, allowing wide and continued use of these dangerous substances, even despite knowing the risks.
- The regulations put in place often make very little sense, which implies other interests besides the well-being for consumers. Consider that while psychedelics have been constantly talked down, that DXM has been in products on US shelves since 1958, and has maintained OTC status despite being known for abuse. DXM is in dozens of products that can be accessed by children.
- Western medicine has repeatedly ignored anything derived by Eastern medicine, regardless of the thousands of years of use of some compounds, and the extensive written information on them that often traverses many different cultures over many centuries of time. This seems to be uniformly done in favor of today’s pharmaceutical companies.
In the end, the processes are close enough, with both leaving plenty of room for both good and useful work to be done, as well as corruption to be had. How much should these medications or these agencies be trusted? Well, you can decide for yourself. But in order to do that, you’ll probably want to check legal suits against these entities, drug recalls, and the numerous reports in both the US and EU for safety issues related to drugs that the public was told were tested and safe.
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Disclaimer: Hi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.