The FDA is Not an Example of Government Success.

[Capt.Ridley_s_Shooting_Party]

There is plenty of evidence that the FDA causes excessive delays in drug certification, and that this has killed tens of thousands of people and caused uncountable others to spend years with less quality than they otherwise might have had. One way to do this is to compare the time-to-market of drugs in the U.S. compared to drugs developed in other countries. For example, drugs in Europe are often available for years before they clear FDA testing in the U.S…

How is this any sort of evidence for your thesis? Are you under the impression that drugs in Europe are untested? If not, then surely you agree that the only thing the above passage implies is that there’s a problem with the specific American implementation of drug certification, not with the idea in general.

The post I made also shows that the recall rate is no different in countries which don’t have an FDA, and which have a history of getting drugs to market quicker. How do you reconcile that?

I reconcile it by recognizing that America and Europe are the world’s two largest consumer market—any drug developed anywhere in the world is going to be sent for FDA/EHEA/MHRA etc. approval at some point. In effect, those countries without the equivalent of the FDA/EHEA/MHRA etc. are leeching off those who do.

It would also help if you could pinpoint a specific group of countries that we’re talking about, as America, Canada and the Eurozone all have FDA equivalents, with India in the process of setting one up, due to rampant abuse. Where exactly are we talking about here? Deepest Africa?

Oh, and the idea of comparing recall rates in countries with the equivalent of no FDA is moronic. Do you honestly believe that a country that doesn’t test drugs before market is going to give a shit if a few people die from faulty medicine, or even keep a reliable track of such things?

[Capt.Ridley_s_Shooting_Party]

@IdahoMauleMan

A product can claim anything it wants. There’s probably some grey area here in terms of laws protecting consumers from fraud and such. And as Sam Stone pointed out, many drugs today are used for off-label use anyway.

They’re used for off-label use after going through testing showing that they aren’t completely deadly. You know, so they won’t kill 107 kids, or something like that.

[Capt.Ridley_s_Shooting_Party]

Let’s inject some facts into the debate about off-label use. Here, directly from the horse’s mouth, the UK’s General Medical Council’s Code of Good Practice in Prescribing Medicines:

19. You may prescribe medicines for purposes for which they are not licensed. Although there are a number of circumstances in which this may arise, it is likely to occur most frequently in prescribing for children. Currently pharmaceutical companies do not usually test their medicines on children and as a consequence, cannot apply to license their medicines for use in the treatment of children. The use of medicines that have been licensed for adults, but not for children, is often necessary in paediatric practice.

20. When prescribing a medicine for use outside the terms of its licence you must:

    1. Be satisfied that it would better serve the patient’s needs than an appropriately licensed alternative
    2. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer’s information may be of limited help in which case the necessary information must be sought from other sources
    3. Take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring and any follow up treatment, or arrange for another doctor to do so (see also paragraphs 25-27 on prescribing for hospital outpatients)
    4. Make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing the medicine.

So, off-label use is most common when prescribing drugs, tested on adults and fully-licensed, for children with the same condition. Further, to even prescribe off-label, it is required that the use is consistent with existing medical practice, and that the medic uses his or her best judgment as a trained medical professional.

[Sam_Stone]

@Capt.Ridley_s_Shooting_Party

How is this any sort of evidence for your thesis? Are you under the impression that drugs in Europe are untested? If not, then surely you agree that the only thing the above passage implies is that there’s a problem with the specific American implementation of drug certification, not with the idea in general.

Exactly right. My point was that the FDA is hurting people because it is too risk averse. My point is also that there is a fundamental contradiction in requiring very expensive and time-consuming efficacy testing for one single use, and then once the drug is released allowing it to be used for anything at all. If ‘off-label’ use isn’t a problem, why require efficacy testing at all?

I reconcile it by recognizing that America and Europe are the world’s two largest consumer market—any drug developed anywhere in the world is going to be sent for FDA/EHEA/MHRA etc. approval at some point. In effect, those countries without the equivalent of the FDA/EHEA/MHRA etc. are leeching off those who do.

This makes no sense at all. The point is that Europe’s regulatory regime is less stringent than the FDA’s, resulting in drugs getting to market on average about 3 years sooner. Despite that, there is no greater incidence of drug recalls in Europe, and no greater incidence of drug disasters among approved drugs. This would also suggest that the FDA is too risk-averse, and that this is hurting people.

It would also help if you could pinpoint a specific group of countries that we’re talking about, as America, Canada and the Eurozone all have FDA equivalents, with India in the process of setting one up, due to rampant abuse. Where exactly are we talking about here? Deepest Africa?

Clearly they do NOT have FDA equivalents, since they get drugs to market 2-3 years sooner than the FDA does. you’re creating straw men.

Oh, and the idea of comparing recall rates in countries with the equivalent of no FDA is moronic. Do you honestly believe that a country that doesn’t test drugs before market is going to give a shit if a few people die from faulty medicine, or even keep a reliable track of such things?

You are engaging in a fallacy here by setting up a dichotomy that does not exist to argue against something I never said. I did not compare recall rates between Botswana and the U.S. - I compared them between the U.S. and the EU, both of which are regulated markets. My point was that it appears that the FDA needs to deregulate to some degree - specifically, by eliminating efficacy requirements.

The larger point I’m making is that many people on the left always seem to accept that regulations are good, that more regulations are better, and will rarely accept that government regulation has gone too far and is doing more harm than good.

You’ve repeatedly brought up the deaths of 107 children as a fact that disproves my thesis. But I also pointed out that delays to market due to over-regulation by the FDA have killed tens of thousands of people, and you just ignore that. No one doubts that the FDA has prevented deaths by keeping dangerous drugs from the market. But we could prevent even more by simply not allowing any drug use at all. Do you think that’s a good idea? If not, why would you automatically assume that the very rigid and expensive FDA approval process is a good thing, merely because we can point to 107 children who were saved by it?

And by the way, under the reform I’m proposing, those kids would still have been saved, because I’m simply talking about getting rid of efficacy testing, and not safety testing.

The other point I’m making is that off-label use disproves the notion that, absent the FDA, there would be chaos in the drug market. Off-label use is pretty much unregulated. Drugs can be used for purposes not even remotely related to the original illness, and used in people such as children who were never part of the initial clinical trials, including safety trials. They can be given to pregnant women, even if the drug was never certified for such use or tested on pregnant women. Basically, the entire onus to maintain safety and use these drugs appropriately is on the practitioners and their various standards and certifying bodies. And yet, there is no apparent safety problem in this part of the industry, and doctors and the AMA overwhelmingly support the continued unregulated use of drugs for off-label purposes.

This suggests to me that such a system could work even if the FDA did not exist at all, but especially if the FDA reduced its role to basic safety testing of the drugs.

[IdahoMauleMan]

@haymarketmartyr

Idaho - I do not think my answer was in the welfare of others. I would say its the opposite - I just do not want to pay for others stupid mistakes. Thats in my own self interest.

Fair enough. Let me run with that for awhile.

I would make a quick passing note, however, that some people (including me, if I was in a different mood) would immediately retort that you are on The Road To Serfdom. That is, your argument that the government needs to get involved in testing is because the government is already involved in healthcare.

Or stated in other terms, because the government is involved it must get even more involved.

But I’ll let that pass for now. Let’s dive into the self-interested part of your argument and attempt to throw some numbers around.

I’m going to temporarily accept your argument that the public will bear the full costs of the deaths caused by drugs that are not tested, and were chosen by unwitting customers.

Let’s begin.

There are costs associated with the FDA. They are

C1. The direct costs associated with it’s existence
C2. The costs required by companies to comply with its laws
C3. The costs of preventable deaths (and maybe more importantly, the ‘cost of suffering’) from drugs it doesn’t allow to market, or doesn’t allow to market fast enough

I think C1 is about $2 billion per year, if my memory is correct. C2 is much, much bigger…probably an order-of-magnitude bigger. I’m not sure how much. I have no idea what C3 is, because it isn’t measured. It’s the important box that so many people miss…Box 3 of the 2x2 matrix of

1. FDA Approved/Will Save You
2. FDA Approved/Will Kill You
3. Disapproved/Will Save You
4. Disapproved/Will Kill You

Most people just focus on Boxes 1 and 4. Box 1 is what the drug companies want. Box 4 is the thalidomide example. The FDA is extremely risk-averse and shoots for Box 2 to be as close to zero as possible.

But Box 3 is a very important box. That’s the box that the free market could open up to those who wish to choose it.

I would argue that C3 is at least as big as C2. Maybe bigger. Adding all three costs together C1 + C2 + C3 is probably many $10s of billions of dollars per year. That’s just an order of magnitude guesstimate. Please poke holes in my hypothesis if you would like to do so.

The self-interested costs you are trying to avoid are the costs of people getting sick and dying. Fair enough.

But data on sick and dying people from suspect drugs spreads very rapidly. Especially in today’s wired society. It strikes me as highly unlikely that many 100s, much less 1,000s, of people would start dying from certain drugs before we would all know about it in short order.

It’s a self-correcting mechanism. Sam cited 107 deaths from a certain drug many decades ago, when information traveled much slower. That strikes me as a high-end benchmark. Can you imagine 107 children dying from suspect drugs in the 2009 and not having it on CNN almost immediately? How long did it take to hear about that Chinese toothpaste thing? That news spread like wildfire.

You would have to believe that people would be dropping dead all over the place, in huge numbers, and that customers would plow ahead and continue to buy suspect drugs to start running up hospital bills that even approach the C1 + C2 + C3 costs outlined above. We’re talking $10s of billions of dollars here.

To be fair, I haven’t subtracted off the costs of the new, free market testing from the C1 + C2 + C3 amount. That is, the costs to the consumer from the new entrants into the testing space that replace some of the FDA functions. But they are almost certain to be <= C1, and <=C2, otherwise the drug companies wouldn’t use them. Even after making that correction you’re still stuck with an order of magnitude in the $10s of billions that ‘the cost of dying’ has to match in order for it to be a poor cost-benefit tradeoff.

Please suggest modifications to my analysis as you see fit.

[Sam_Stone]

@Capt.Ridley_s_Shooting_Party

Let’s inject some facts into the debate about off-label use. Here, directly from the horse’s mouth, the UK’s General Medical Council’s Code of Good Practice in Prescribing Medicines:

So, off-label use is most common when prescribing drugs, tested on adults and fully-licensed, for children with the same condition. Further, to even prescribe off-label, it is required that the use is consistent with existing medical practice, and that the medic uses his or her best judgment as a trained medical professional.

And who ever said anything to the contrary? And while pediatric use is a very common form of off-label use of drugs, there are plenty of others. Those doctors surveyed reported that up to 40% of the prescriptions they write are for off-label uses.

In addition, doctors routinely prescribe over the counter medications in uses for which they were never originally certified. In some cases, the FDA has actually killed people by preventing information about these uses to be spread. For example, the FDA disallowed the advertisement of Aspirin for use as a heart attack preventative, despite plenty of clinical evidence that for some people, an aspirin a day could significantly reduce the risk of heart attack.

From here:

On December 8 [2003], the FDA’s Cardiovascular and Renal Drugs Advisory Panel voted not to support using aspirin for the primary prevention of heart attacks. The petition to approve aspirin for reducing the risk of heart attack in moderate-risk patients (those whose 10-year risk for heart attack is 10% or greater) was brought to the panel by the Bayer Corporation.
…
The FDA panel was merely being scientifically “pure” in making this vote. One of the panel members noted that what was needed is a seven-year trial enrolling 15,000 patients in the moderate-risk group, and until such data was available FDA should not give its stamp of approval.

But while agreeing with this opinion, another panel member further noted that aspirin’s overall benefits have been so well-documented that it would probably be unethical (and certainly unfeasible) to actually perform such a trial.

It is worth mentioning that during the open hearing before this panel, the American College of Cardiology, the American Diabetes Association, the American Heart Association, and the US Preventative Services Task Force supported the use of aspirin in moderate-risk individuals. Further, several panel members who voted against the petition remarked that they themselves take aspirin every day, and recommend that their patients do the same. The panel seems convinced that aspirin should be used - they just didn’t have the statistical evidence sufficient to allow a labeling change in this particular subset.

The bottom line: All this vote means is that the Bayer company will not be able to promote aspirin for moderate-patients in their advertising. Doctors will continue recommending aspirin (even some of those in the FDA panel that voted in the negative) for patients who have a moderate risk of heart attack.

That’s your FDA in action. Against the advice of several major medical associations, and presented with clinical evidence as to the efficacy of the medicine, and even while acknowledging that the safety of Aspirin had been well established and the board members took it themselves for exactly the purpose they were ruling on, they still declined the petition to allow information to be disseminated to the public.

Their ruling stated that the only way they could make this allowance would be after a 7.5 year trial involving 15,000 people, which even they agreed would be unethical and not feasible to carry out. So, by the FDA’s own admission, the Bayer company was permanently barred from telling people about a life-saving benefit of their product.

Does that make any sense to you?

[Capt.Ridley_s_Shooting_Party]

@Sam_Stone

Exactly right. My point was that the FDA is hurting people because it is too risk averse. My point is also that there is a fundamental contradiction in requiring very expensive and time-consuming efficacy testing for one single use, and then once the drug is released allowing it to be used for anything at all. If ‘off-label’ use isn’t a problem, why require efficacy testing at all?

As already pointed out, there is no contradiction with off-label use.

This makes no sense at all. The point is that Europe’s regulatory regime is less stringent than the FDA’s, resulting in drugs getting to market on average about 3 years sooner. Despite that, there is no greater incidence of drug recalls in Europe, and no greater incidence of drug disasters among approved drugs. This would also suggest that the FDA is too risk-averse, and that this is hurting people.

Nice try. Drugs getting to market three years sooner isn’t necessarily indicative of different standards of testing. For example, the FDA may be unable to cope with a backlog of drug testing applications. How about you produce some evidence that e.g. the MHRA is less stringent than the FDA?

Clearly they do NOT have FDA equivalents, since they get drugs to market 2-3 years sooner than the FDA does. you’re creating straw men.

What are you talking about?

You are engaging in a fallacy here by setting up a dichotomy that does not exist to argue against something I never said. I did not compare recall rates between Botswana and the U.S. - I compared them between the U.S. and the EU, both of which are regulated markets. My point was that it appears that the FDA needs to deregulate to some degree - specifically, by eliminating efficacy requirements.

Again, what are you talking about? The MHRA performs safety and efficacy testing, just like the FDA.

The larger point I’m making is that many people on the left always seem to accept that regulations are good, that more regulations are better, and will rarely accept that government regulation has gone too far and is doing more harm than good.

This isn’t a left-vs-right issue. I’m a conservative and I still think your ideas are stupid.

You’ve repeatedly brought up the deaths of 107 children as a fact that disproves my thesis. But I also pointed out that delays to market due to over-regulation by the FDA have killed tens of thousands of people, and you just ignore that.

I’ve ignored it because it’s something you’ve pulled out your ass. How about I pull something out of mine? Stringent FDA testing has saved millions more people than have died from drug-licensing delays. There, we both can do it.

If not, why would you automatically assume that the very rigid and expensive FDA approval process is a good thing, merely because we can point to 107 children who were saved by it?

Because nobody with a brain believes that those 107 were the only victims.

The other point I’m making is that off-label use disproves the notion that, absent the FDA, there would be chaos in the drug market.

This is pretty much given, as your OP demonstrates.

Off-label use is pretty much unregulated. Drugs can be used for purposes not even remotely related to the original illness, and used in people such as children who were never part of the initial clinical trials, including safety trials.

No it isn’t unregulated, at all. Off-label use is covered by the GMC’s Code of Conduct, and as a result any misuse is grounds for striking off the medical register—it isn’t like a physician can prescribe a random drug for a random illness. Further, only a fifth of drug prescriptions are off-label, and the majority of them are prescribing licensed drugs to children where only the dosage is changed.

[Tamerlane]

Without getting involved in the nitty-gritty of this drug debate, I would like to add that FDA stands for Food and Drug Administration and they do considerably more than just approve pharmaceuticals.

I had a roommate at one time, an FDA employee, who worked entirely on issues of food quality, including the monitoring of imports, federal labeling laws ( partially obfuscated by political interference, especially from Orrin Hatch re: herbal supplements ), as well as inspection of domestic food production facilities ( a duty shared with, but not identical to that done by the USDA ) and the tracking of contamination outbreaks ( i.e. as with the melamine disaster a little while back ). From my exposure I’d say that focusing only on the drug side of the FDA’s mandate in determining it’s usefulness is only covering half ( or less ) of the argument.

[Deeg]

@Sam_Stone

**Next Problem - Reduction in New Drugs Overall **

Since the introduction of the 1962 amendments to the Pure Food and Drug Act, the number of firms researching drugs, and the number of new drugs entering the market, has declined. The problem is getting worse. In an age where technology is providing increased choice and new products to people in every other industry, the number of new drug releases has been decreasing steadily. Only 16 new drugs were approved in 2007, and 18 in 2008.

Wouldn’t we expect the same result if the FDA was perfectly performing its function? Requiring FDA approval means that quack pharmaceuticals might as well close up shop. Drugs that have no benefit do not enter the market.

[Voyager]

I’m a bit confused. If Sam is saying that the FDA is not the best regulatory agency the world has ever seen, or even not as good as in Europe, I have no argument. I’ve seen criticisms of it for both doing too much and too little. We only know how many lives it could have saved before it started (and no doubt many more not recorded or dying from more subtle drug effects), not how many it has saved by preventing dangerous drugs on the market.

As for efficacy, once you grant the need for the FDA for safety, how do you consider the case where a person taking a useless drug dies from not taking a useful one. Could a useless drug that is on the market block the development of a useful one, for market reasons? Now, studies have shown that expensive placebos seem to work better than cheap ones, so there is some benefit to useless drugs being on the market, but might safe but useless drugs crowd out safe and useful, if more expensive, ones?

I’m all for off-label use, given the kind of guidelines they have in England, since I think these are used when there is no proven on-label remedy, safety has been proven, and there is no false claim of efficacy.

[Todderbob]

I should be ultimately responsible for what I do and do not put into my body.

If I want to put a ton of opiates into my body, to get me hopped up 24/7, why shouldn’t I be allowed to?

I can understand the need to regulate Antibiotics, as there’s a level of public safety (resistant diseases) involved, but what good reason is there to prevent me from doping myself up? I won’t drive drive when hopped up, operate heavy machinery, etc.

If I can be trusted to drink booze, why can’t I be trusted to pop pills?

[IdahoMauleMan]

@Trocisp

I should be ultimately responsible for what I do and do not put into my body.

If I want to put a ton of opiates into my body, to get me hopped up 24/7, why shouldn’t I be allowed to?

I can understand the need to regulate Antibiotics, as there’s a level of public safety (resistant diseases) involved, but what good reason is there to prevent me from doping myself up? I won’t drive drive when hopped up, operate heavy machinery, etc.

If I can be trusted to drink booze, why can’t I be trusted to pop pills?

You’re being far too rational, and showing a willingness to be accountable for your own decisions. Neither seems to be in particularly abundant supply when it comes to this particular debate.

[Honesty]

@Sam_Stone

If ‘off-label’ use isn’t a problem, why require efficacy testing at all?

Off-label use of drugs probably isn’t considered a big deal because the individuals prescribing these drugs are well-versed with the pharmacology. Let me give you an example. I have (or had) pseudofolliculitis barbae which is relatively common in African-American men who shave frequently. I’ve been to doctors since I was 18 for this problem. Dermatologists have prescribed all sorts of drugs ranging from antibacterial creams to laser hair removal on the beard area.

I met with a spritely, young Dermatologist who prescribed the drug accutane which is intended for people with severe acne. She rattled the reasons why she felt it would help me. Well, not only did the drug clear up my face but it suppressed further occurences. I’ve been off the drug for two months and I look 4 years younger (of course, I’m only 27).

I am grateful that doctors, like my dermatologists, can examine the mode-of-action of drugs and prescribe them based on the patient’s needs.

In any case, I don’t think the FDA was intended to micromanage the dispension of drugs by doctors, just to ensure the medicine is safe for consumption by the public.

[kaylasdad99]

Is this thread really about whether the FDA is an example of Government success? Or is it about the imperfections of the FDA, and a debate over whether “the left” wishes to exacerbate those imperfections?

It’s been pointed out that the FDA is not as efficient/effective as European phamaceutical regulatory agencies. Are these superior bodies not government agencies? If they are, would it be unfair to point to them as examples of Government success?

[Todderbob]

@IdahoMauleMan

You’re being far too rational, and showing a willingness to be accountable for your own decisions. Neither seems to be in particularly abundant supply when it comes to this particular debate.

Don’t misunderstand… I fully support the FDA.

I just don’t want to be bound by their bullshit decisions.

[IdahoMauleMan]

@kaylasdad99

Is this thread really about whether the FDA is an example of Government success? Or is it about the imperfections of the FDA, and a debate over whether “the left” wishes to exacerbate those imperfections?

It’s been pointed out that the FDA is not as efficient/effective as European phamaceutical regulatory agencies. Are these superior bodies not government agencies? If they are, would it be unfair to point to them as examples of Government success?

That’s a really good question.

I don’t want to speak for Sam, but I think it was an attempt to narrow down the argument a bit from the ‘Libertarian/fringe’ thread, which started to take off around post #132.

Personally, I’m not interested in defining a measuring stick of ‘successful’ for one particular government body or the other. I’m interested in debating why free markets, and free choices by individuals, can choose to incorporate or not incorporate the outputs from those agencies at their personal discretion.

[haymarketmartyr]

Trocisp
its pretty simple
1- when you do these things to your own body, I do not want to be around to see the damage you could cause to other people

2- even if you never harm anyone, and only harm yourself, I do not want my tax dollars paying for care for you for the rest of your life when you do something stupid and need expensive medical care or support for the next fifty years.

Your claim that you won’t do anything bad while on pills is pure crap. Sorry to be blunt - but it is.

[Todderbob]

@haymarketmartyr

its pretty simple

Okay, haymarketmartyr, explain it to me real nice and simple, like.

@haymarketmartyr

1- when you do these things to your own body, I do not want to be around to see the damage you could cause to other people

I didn’t say you had to be around it. Did I?

I should be perfectly allowed to ingest whatever I want, in the privacy of my own home. Without fear of government reprisals. I’m a(n) (relatively) intelligent adult, I know the risks.

@haymarketmartyr

2- even if you never harm anyone, and only harm yourself, I do not want my tax dollars paying for care for you for the rest of your life when you do something stupid and need expensive medical care or support for the next fifty years.

Because people who drink never do anything stupid?

Should we ban booze? People get in wrecks, or get Alcohol poisoning and go into vegetative states all of the time.

There is no evidence that recreational usage of Pills, by adults, leads to more injuries than recreational alcoohol usage.

@haymarketmartyr

Your claim that you won’t do anything bad while on pills is pure crap. Sorry to be blunt - but it is.

Prove it.

[Deeg]

@Trocisp

If I want to put a ton of opiates into my body, to get me hopped up 24/7, why shouldn’t I be allowed to?

For me, the reason is because there is a cost to society when people are hopped up 24/7. For example, increased crime and problems with drug addled babies. The cost of being hopped up is debatable (and thus its legal standing) but the principle is this: if something has a detrimental effect on society at large then it is (IMO) open for potential regulation.

The amount of regulation should be apportioned to the cost. Cigarettes have a relatively low cost so you are allowed to pump your body full of nicotine 24/7 (as long as you don’t do it near me.) To take an extreme example, the potential cost of privately-owned nuclear weapons is astronomical and so they are regulated with a complete ban. Opiates are somewhere in the middle.

The FDA is an attempt to manage the cost of food and drugs to society. It doesn’t do everything right, of course (I believe it over-rates the dangers of pot) but that doesn’t mean it doesn’t work.

[Todderbob]

@Deeg

For me, the reason is because there is a cost to society when people are hopped up 24/7. For example, increased crime and problems with drug addled babies. The cost of being hopped up is debatable (and thus its legal standing) but the principle is this: if something has a detrimental effect on society at large then it is (IMO) open for potential regulation.

Alcohol.

Why the difference in regulation?

@Deeg

The amount of regulation should be apportioned to the cost. Cigarettes have a relatively low cost so you are allowed to pump your body full of nicotine 24/7 (as long as you don’t do it near me.) To take an extreme example, the potential cost of privately-owned nuclear weapons is astronomical and so they are regulated with a complete ban. Opiates are somewhere in the middle.

The FDA is an attempt to manage the cost of food and drugs to society. It doesn’t do everything right, of course (I believe it over-rates the dangers of pot) but that doesn’t mean it doesn’t work.

The free market dictates that if I can afford to purchase opiates, I must be doing my job properly.

If you’re worried about drug-babies, make it illegal to consume Opiates or alcohol while pregnant. Don’t force me, a man who cannot get pregnant, to suffer because an entirely different sub-group of people (pregnant women) may put another entirely different group of people (fetus’) in danger.
It’s like banning ski masks in Idaho because they like to use them for robberies in Georgia. :smack: