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Recreational science?
October 23, 2010 9:26 PM   Subscribe

Would it be legal in America for a pharmaceutical company to develop a drug solely intended for recreational, not medical purposes. To what safety standards would such a drug be held?
posted by furiousxgeorge to Law & Government (26 answers total) 4 users marked this as a favorite
 
Well, legal, sure. I mean there are hundreds of prescription drugs that people take recreationally all the time. I mean pretty much any opiod or amphetamine is prescription.

The point here is prescription. You have to have one and a valid reason to have one to get one.
posted by sanka at 9:31 PM on October 23, 2010


No, I mean straight up Pfizer says we are doing research to develop a safe recreational drug.
posted by furiousxgeorge at 9:37 PM on October 23, 2010


Anything like that would be prescription only, unless they found some long lost herbal thing. Everyone is already smoking, drinking, making tea or eating all the non regulated things that alter consciousness. Humanity has had thousands of years to get high, we know what does it.

I guess what I mean is that if it does it better than beer or liquor, we already found it. And if we haven't, it'll be regulated like hell. It would never be OTC, and then it would have to pass FDA standards.
posted by sanka at 9:49 PM on October 23, 2010


This is not legal advice, and I am not the OP's attorney.

The OP asked about drugs created solely for recreational use. I can think of at least three which are legal: alcohol, tobacco (nicotine) and caffeine. These are regulated by some combination of the FDA and the ATF. But I'm not sure we're ever likely to see other drugs achieve this almost non-drug status.

Under the Controlled Substances Act, which would likely cover your hypothetical drug, probably the key issue is the potential for abuse. Since your drug has no accepted medical use, it could fall into Schedule I - essentially, an illegal drug - if it is found to have a potential for abuse and if it is unsafe. The FDA and DEA determine what schedule a drug is placed on.

Now, you say in your hypo that your drug is "safe." Well, I don't like to fight hypotheticals, but as a political matter, it's very hard to see a recreational drug judged as "safe." The pressure to declare it unsafe would be intense. Marijuana is on Schedule I because it is considered "unsafe."

But I guess the answer is that the FDA would regulate this drug. Since it has no medical value, I'm guessing it wouldn't make sense to submit a New Drug Application. Yet somehow they'd have to demonstrate the drug's safety. I guess you'd look to those three drugs I mentioned earlier as the model - caffeine, tobacco, and alcohol. I'm not really sure our current legal and political system is set up to handle your hypo, though.
posted by Conrad Cornelius o'Donald o'Dell at 9:54 PM on October 23, 2010 [5 favorites]


I'm not looking for speculation on if it is feasible, I'm certain no one knew about the recreational possibilities of JWH-018 for instance until recently, I'm only interested in if there would be any legal barriers to undertaking the goal and to what standards the finished product would be held.
posted by furiousxgeorge at 9:55 PM on October 23, 2010


Alexander Shulgin did some work for the DEA, on the side he used the license he needed for that to develop and test a bunch of drugs - see wikipedia. A lot of the "herbal highs" we now get are his chemicals.

He ended up getting raided several times, though nothing really stuck. I guess it is technically legal, but couldn't really see a large drug company taking it up. Much better to make something that technically cures an illness (like Viagra) but is open to abuse.

In NZ at least, there are very few safety standards for any recreational drugs, as long as you don't claim it is a medicine, although there is currently legislation coming through to make them illegal by default and require ridiculous safety tests to allow them for sale. I don;t know what kind of regulations other countries have.
posted by scodger at 10:00 PM on October 23, 2010


A bit of understanding of The Controlled Substances Act is in order here. The DEA and the FDA sort drugs into schedules based on their abuse potential, medical uses, and safety. Schedule I drugs are the ones we think of as illegal drugs: marijuana, heroin, MDMA, and others (though cocaine is Schedule II). By law, these are drugs that are supposed to have a high potential for abuse, have no currently accepted medical use, and aren't considered safe to use under medical supervision. Schedule I drugs cannot be prescribed by physicians, and can only be produced in limited quantities for research use with approval from the DEA. Schedules II-V cover increasingly less risky tiers of substances, at least in theory, as there are many inconsistencies in the scheduling of drugs.

So we have Schedule I substances, which are illegal to possess or use for any reason (ignoring research with a permit here), and Schedule II-V substances, which are illegal to possess or use except when prescribed by a licensed prescriber with a DEA number, dispensed by a licensed pharmacy with a DEA number. There are also various controls over wholesalers and distributors to prevent diversion.

So with your hypothetical drug, the DEA would have the opportunity to review it in order to schedule it under the CSA. This drug would have no accepted medical use, which would be a major strike against it. Furthermore, there's very good reason to believe that such a drug would have at least some dependence or abuse potential. I'm no neurobiologist, but it's clear that recreational drugs feel good because of their effects on neurotransmitter levels in the brain. Most such substances are going to produce at least some degree of physical and/or psychological dependence in their users, which the DEA would certainly frown upon.

Now, could you develop a recreational drug safer than caffeine or tobacco or alcohol? Almost certainly. But there's no requirement that the DEA be logical in their scheduling decisions and they very much aren't. Heroin is a Schedule I opioid with three times the potency of morphine while morphine and fentanyl (with 80 times the potency of morphine) are schedule II drugs.
posted by zachlipton at 10:05 PM on October 23, 2010 [1 favorite]


Your mention of JWH-018 (which I had not heard of until now) is instructive. According to Wikipedia, a number of states have already banned it, and the DEA has issued an alert. I'll bet federal legislation is a possibility. Salvia divinorum faces a similar situation.

So while your hypothetical might have some academic interest (it could make a good law school exam question), as a political (and cultural) matter, I think it's a non-starter. I'm betting no major pharma company would risk its rep like that (what happens the first time some kid DOES overdose on your supposedly "safe" drug that has no medical value whatsoever?), and some upstart firm would get squished by regulators and/or legislators.

Yes, I realize people die alcohol-related deaths all the time (and Anheuser-Busch is still in business), but as I alluded in my earlier comment, alcohol goes waaay back. It's just a built-in part of our culture. I don't think any new drug could achieve that cultural status.
posted by Conrad Cornelius o'Donald o'Dell at 10:08 PM on October 23, 2010 [1 favorite]


Furthermore, the Food and Drug Act's definition of a drug includes "articles (other than food) intended to affect the structure or any function of the body of man or other animals." Surely your substance, unless it was a naturally occurring herb, would be classified as a drug, and would require FDA approval for safety and efficacy to sell.
posted by zachlipton at 10:12 PM on October 23, 2010


I'm sure that you can develop any substance and ingest it yourself without legal consequence, as long as it only involve you. However, transferring possession of said substance to another person in return for money is trade, and that is regulated by law. The person who buy it from you are at a disadvantage because it's not possible for that person to ascertain your claim (this substance will only get you high with no side-effect). In essence, that person have to trust your claim that said drug will do what you say it does. That's the reason why there must be regulation and regulators regarding advertising, claims, efficacy and purity...etc. All drugs are medical, because they all affect the body one way or another (else, why would the consumer buy it from you?); and because the human body is an extremely complex and diverse system, it takes lots of knowledge, observation, testing in order to ascertain the effect of a drug, even in carefully controlled environments.

In short, yeah, you can do anything to your body. However, if your product is going to affect the body of another person, it's totally reasonable for the government to question and control your product. In a way, food items (and supplements) are loop holes in the otherwise strong protection provided by the government to protect consumer from ingesting products they did not make themselves. The standard it will be held to is whether it does what it claims to do and nothing more.
posted by curiousZ at 10:14 PM on October 23, 2010 [1 favorite]


and would require FDA approval for safety and efficacy to sell.

But this is the problem I mentioned earlier: Efficacy for what? A drug has to be medically effective to gain approval. There's no medical use here, so almost by definition you can't file an NDA on it. You have to show that the benefits outweigh the risks - but as far as the FDA is concerned, there are no benefits. So I think this hypo grinds to a halt.
posted by Conrad Cornelius o'Donald o'Dell at 10:18 PM on October 23, 2010


Yes, JWH-018 is a good context to look at this in. Although the FDA has expressed concern and several states have acted, there is no clear federal rule. JWH-018 was NOT discovered for recreation, but that is what it is used for now and it remains federally legal, which is one of the things that inspired me to ask this hypothetical.

If by chance a product can enter legal trade for recreational purpose, why could it not be done intentionally? Is the only separation the "herbal incense, not for human consumption" disclaimer on the websites?
posted by furiousxgeorge at 10:20 PM on October 23, 2010


What if you presented a tested safe, recreational drug as a short duration anti-anxiety or anti-depression med?
posted by furiousxgeorge at 10:21 PM on October 23, 2010


Finally, I don't think you could truly make a recreational drug that didn't have some reasonable medicinal use. Depressants are commonly used to treat pain, anxiety, insomnia, seizures, colds and coughs, and allergies, in addition to being part of anesthesia regimens. Hallucinogens have been studied in the treatment of post-traumatic stress disorder and other psychological conditions. They can also be helpful in treating the above conditions as well. Stimulants are used to treat ADHD, fatigue (including fatigue caused by other illnesses or drugs), depression, obesity, narcolepsy, and Parkinson's. Your drug might not be a particularly good treatment, but I can't imagine that it wouldn't be useful for some medical purpose.
posted by zachlipton at 10:26 PM on October 23, 2010 [1 favorite]


What if you presented a tested safe, recreational drug as a short duration anti-anxiety or anti-depression med?

First of all, the standards to sell a drug over the counter (that is, without a prescription) are much higher than for normal prescription drugs. Your drug would still require a prescription unless the manufacturer convinced the FDA of this even higher level of safety.

Secondly, the FDA's approval process is separate from the FDA/DEA's scheduling process. The FDA could easily approve your drug as safe and effective and it could be scheduled as a controlled substance. As such, it would be illegal to use or possess it without a valid prescription. Furthermore, the DEA could go after doctors for prescribing it solely for recreational use, in the same way they have gone after doctors who prescribe a lot of pain medication or other controlled substances.
posted by zachlipton at 10:35 PM on October 23, 2010


I don't think prescription or not is relevant in that case, as everyone suffers from short term anxiety and depression if a drug is safe enough they could legitimately be prescribed it.
posted by furiousxgeorge at 11:11 PM on October 23, 2010


What if you presented a tested safe, recreational drug as a short duration anti-anxiety or anti-depression med?

Well, you could make the argument that viagra is essentially a recreational drug doing just that.
posted by rodgerd at 11:13 PM on October 23, 2010 [1 favorite]


Practically, it won't happen, but strictly speaking, there's no legal barrier before the fact. If a company developed a novel recreational drug, sufficiently distinct to avoid the Analogues Act, and didn't package it as a drug i.e. as a pill or powder..etc but rather as a drink containing that substance, then it wouldn't be off the bat illegal. But in practice, as soon as there were some documented reports of adverse reactions, the DEA Administrator would do an emergency scheduling, most likely, into Schedule I.
posted by daksya at 11:21 PM on October 23, 2010 [1 favorite]


I don't think prescription or not is relevant in that case, as everyone suffers from short term anxiety and depression if a drug is safe enough they could legitimately be prescribed it.

Sure, but we already do this now and we do it all the time. Look at the top 200 prescription drugs in the US by number of prescriptions (not a great list because they list generics multiple times by manufacturer, but it's enough to get the point). Numbers 1 and 3 are Hydrocodone/APAP, also known as Vicodin. Other top drugs include zolpidem (Ambien), Alprazolam (Xanax), and Oxycodone/APAP (Oxycontin). All are controlled substances. Everyone suffers from short term pain and many receive legitimately prescribed painkillers. Many people abuse painkillers and obtain them illegally as well. Why go to the expense to develop a new drug for recreational use when we have so many? Xanax, Ativan, and friends are quite safe in moderation (IANAD) if taken by patients in good health, not combined with alcohol or other depressants, and if patients don't drive on it, but they can cause dependence. Your new recreational drug will almost certainly cause some degree of physical or psychological dependence too.

Besides, medical boards and the DEA can and do go after doctors who don't prescribe legitimately. A doctor handing out this stuff like candy for recreational purposes would lose his/her license and could go to jail.
posted by zachlipton at 11:38 PM on October 23, 2010


If a company developed a novel recreational drug, sufficiently distinct to avoid the Analogues Act, and didn't package it as a drug i.e. as a pill or powder..etc but rather as a drink containing that substance, then it wouldn't be off the bat illegal.

I'm no expert on the Food and Drug Act, but my understanding is that the packaging doesn't matter: this would still be a new drug subject to FDA approval requirements and your drink would be an illegally sold unapproved drug. You might be able to get away with it until the DEA if your drug was a naturally occurring foodstuff, but not for any novel chemical substance. Besides, you'd need it to be a novel chemical substance to get a patent on it and make the whole exercise worthwhile anyway.
posted by zachlipton at 11:43 PM on October 23, 2010


Besides, medical boards and the DEA can and do go after doctors who don't prescribe legitimately. A doctor handing out this stuff like candy for recreational purposes would lose his/her license and could go to jail.

The opiates and benzos are physically addictive and the Ambien has limited (but some) recreational potential. I don't think they are a good comparison to a hypothetical safe drug, and if you have a hypothetical safe drug for anxiety/depression it would not be off label to hand it out like candy.

I think people are getting too focused on shooting down the possibility of the hypothetical here and not as much looking at the legal which is what I am interested in.
posted by furiousxgeorge at 11:50 PM on October 23, 2010 [2 favorites]


The focus here is on strict legality and not commercial feasibility. If the novel drug ingredient viz. the drug effect, wasn't emphasized in promotional materials, at least explicitly, AND its strcuture was similar to a natural substance, then I think one would get away with it till the first adverse reports.
posted by daksya at 11:57 PM on October 23, 2010


For a sufficiently broad definition of "recreational", isn't this what any artificial flavor / color / sweetener is? Even in those cases, as I understand it, the seller will have to go through the FDA before it can sell a novel compound for ingestion.

So I guess the question is, if you try to get FDA approval for some food additive that produces, say, a mild euphoria, with absolutely no negative effects or intoxication even at absurdly high doses, is the FDA required to reject it, or is it just pretty much a foregone conclusion that they will opt to reject it?
posted by hattifattener at 12:55 AM on October 24, 2010


A true contemporary pharma company would have some medical association define a new condition that is made of a lack of euphoria, and then target that market. Either that, or sell it as an antidepressant and/or diet aid.
posted by 3mendo at 1:47 AM on October 24, 2010 [1 favorite]


This is what happens (via the news I've seen it happen many times in some countries)

1. A new, safe, recreational drug is found. It's legal either because it's not on any list yet, or it was expressly designed from a cocktail of things already established to be legal.
2. People start to use it at raves and concerts.
3. The location of use (raves and concerts) gives it the same context as highly illegal drugs. The drug is thus seen as socially undesirable and dangerous, regardless of whether it is.
4. After enough time, someone dies or gets hospitalized, and because the new drug was something they also took that night, amidst a dangerous cocktail of other drugs.
5. New drug is declared dangerous, the New Big Thing your kids might die from.
6. The law is changed to add the new drug to the list of prohibited drugs. Just Because.

In essence, the police and enough of society are against ANY recreational use of drugs, against the concept, such that any such drug that is safe and legal will quickly become illegal, simply because people don't want recreational drugs around their kids, safe or otherwise. (The big three are culturally established and are typically not even considered drugs, so they get a free pass)

I'm not a user myself, this process of discovery and law changing has happened enough that the good safe stuff has been done and made illegal, such that the latest "herbal highs" are really really lousy from what I hear.

Ironically, it also sounds like many people are experimenting with more dangerous cocktails to find something legal. Legal but medically unsafe is better than medically safe but illegal for many.
posted by -harlequin- at 4:24 AM on October 24, 2010 [2 favorites]


I think people are getting too focused on shooting down the possibility of the hypothetical here and not as much looking at the legal which is what I am interested in.


I think that might be because the hypothetical is inherently problematic.

In order for a pharmaceutical company to engineer a drug that isn't habit forming, doesn't induce tolerance or desensitization, causes no additive cognitive impairment with heavy use, and has no more potential health risk than a placebo, it would have to make so many huge advancements not only in the field of pharmacology, but in our very understanding of the human brain, that marketing the compound recreationally would be an afterthought. Before they needed to even worry about the legality of marketing it recreationally, they would make so much money profiting off all the huge medical advances entailed that the U.S. government would be a licensed subsidiary of theirs, and they could just make it legal by decree.
posted by patnasty at 7:57 AM on October 24, 2010 [1 favorite]


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