FDA to Regulate Internet Drug Sales

ThatGuyAZ writes "The Clinton Administration today announced that it'll be seeking to license all internet drug sales. This seems to be the first step in sweeping the power to regulate these transactions from the states to the federal government. (States currently license pharmacists.) I know the /. libertarians want no regulation at all (right up until they receive a bad prescription themselves), but is giving this problem to the federal government really a solution? Will this soon be happening with state-based licensing of lawyers, doctors, etc.? " Very interesting application of the inter-state commerce clause, although my unschooled opinion is that it's a defensible application of said clause.

Re:I Know I Can't Fill My Own Perscriptions

With these facts in hand, one can make an informed decision instead of just swallowing pills and hoping that the right combination makes you fell better.

Removing prescription laws wouldn't prevent you or anyone else from doing the right thing and having a doctor prescribe your medication. It also wouldn't remove the manufacturers' responsability to make medical grade products, and to label them properly. It wouldn't remove the pharmacists' responsability to dispense what you ask for.

A doctor would still be responsable for what is prescribed to you. Just as he would be if he told you to drink a gallon of (non-prescription) antifreeze and call in the morning.

What prescription laws really are is an assumption that most of us are darwin award cantidates [darwinawards.com] and the foolish notion that we idiots won't 'find' another way to win the award. The same people who would die without prescription laws probably take their prescription sleeping pills with a pint of vodka (because they'll be more effective that way) and operate a blow drier in the bathtub (saves 5 whole minutes in the morning).

If the prescription awards are necessary, perhaps we should also card people (for an electrician's license) before selling them light bulbs, wall switches, or any tool that can be used to work on electrical equipment. Perhaps a mechanic's license to buy auto parts (people DO die regularly from improperly secured cars slipping off the jack).

Or we could save a ton of money and just require warning labels on what are now prescription drugs.

What about ordering internationally?

What about a US citizen ordering medication from a pharmacy in, say, New Zealand? There are many legitimate reasons to take advantage of the regulations regarding imported medicines (a three-month supply for one person is actually protected under US Customs laws); for example, some medicines are vastly cheaper when ordered abroad (for example, certain hormones are $45 for a three-month supply ordered from New Zealand instead of $200+ for a one-month supply purchased in the USA), and some are difficult or impossible to get a prescription for in the USA (many "smart" drugs, for example, or hormones taken for various purposes which the medical community frowns upon - not everyone wants to fit neatly into the XY-male/XX-female sex stereotype which they were born into). Also, in the case of ordering from New Zealand, it's not as though they're a third-world nation where any product you order will be incredibly shoddy; usually it's the exact same stuff as produced in the United States or in England.

Does this only apply to prescriptions ordered online from US pharmacies? They're already regulated, at least at the state level. If it applies to international pharmacies as well, that means they're hoping to override a very convenient, useful, and oftentimes necessary loophole purposefully left in the US Customs laws. I just don't really see what this attempt at regulation is trying to help; certainly not consumers.
---
"'Is not a quine' is not a quine" is a quine.

Re:There are reasons

This is all sanctimonous, patronizing bullshit.

With respects to the whole concept of prescribing drugs, the average citizen is an idiot.

So should I be denied direct access to medication just because my next door neighbours are idiots? I think not.

This is why we have smart people who are licensed to make certain decisions for us, like doctors.

What are you talking about? Most doctors are idiots as well. Six years of gruelling study at medical school doesn't prove that you are infallible, smart or even responsible, it just proves that you can withstand six years of gruelling study at medical school. There have been more than enough scandals about incompetence, negligence and sexual assault to make this obvious.

If you have a medical problem that can be treated with prescription drugs, you have to get a doctor to make that diagnosis and decision.

For those who have to pay to see a doctor, they are victims of an extortion racket. For those whose treatment is paid for by the state, they get to wait...and wait...and wait, just for an appointment. then they have to go and wait and wait etc. in a waiting room full of sick people who are much more likely to be infecting you with something contagious than would be the case anywhere else.

The doctor writes out a prescription, so that the pharmacy knows you've gotten a doctor's consent before they go handing out potentially lethal drugs

You hope. What if the doctor doesn't know what drugs to prescribe? What if he/she prescribes drugs that are dangerous? This happens all the time. If any General Practitioner has to prescribe a medication that they are not familiar with, what do they do? They look it up in a book. In the case of British doctors, the same book I have in my study actually. They often don't even bother to check the appendix listing contra-indications. When confronted with this on more than one occasion I've had to tell the doctor "No, you can't prescribe that, because I'm already taking XYZ".

Many GPs I've dealt with seem to have rested on their laurels ever since graduation. There is very little pressure on them to keep up by reading medical journals etc. The only ongoing education most of them get is the spiel and the promotional literature from the pharmaceutical sales rep. In what way are they providing an expertise that we can't provide for themselves?

Would you really rather live in a country where anyone can buy any sort of drug and use it as he desires?

Yes, within reason.

What happens when that drug, or perhaps a certain mixture, causes sterility? Heart failure? Death? "Oh shucks, he should have known better."?

We deal with dangerous things all the time in our normal daily lives. Sharp knives. Power tools. Motor cars. Hang-gliding. SCUBA diving. Football. Large dogs. Fire. Swimming after lunch.

And *if* you're American, what about the American obsession with guns?

It has always been like this, it's called *life*. To attempt to protect everybody from hurting themselves is not only impractical, it's undesirable. We have the right to make our own choices and take our own risks. All we need is the ability to stay fully informed about those risks.

There are perfectly sane, legitimate reasons we license and prescribe drugs in this country.

They are only legitimate because they are written in law. But they are not justice. No-one has the right to tell me what I can and can't put in my body. It's *my* fucking body.

Consciousness is not what it thinks it is
Thought exists only as an abstraction

Just to play devil's advocate

I vehemently oppose regulation of speech, etc., but I fail to see the terrible harm that would come of safeguarding against bad medicines.

Consider the folowing scenerio:

Tribal lore in an undisclosed State, on an undisclosed Indian Reservation, has managed to preserve a remarkably effective treatment for [insert your favorite ailment here] in the face of several hundred years of seige to their culture by European settler's.

A large pharmaceutical company "discover's" the tribes technique, finds it to be useful, and co-opts the idea. Perhaps they are granted a patent, or perhaps merely FDA approval. Either way, the regulartory apparatus of our government will always work in favor of the drug pusher^H^H^H^H^H^H company and against the folk doctors in question. The result? It will probably be unlawful for the tribe to continue practicing medicine in the way they have for thousands of years, while the drug company will likely get exclusive rights to market their treatment, probably at a much inflated price.

This is an example where "safeguarding against bad medicines" does indeed do immediate and ongoing harm.

Real world examples? Synthetic THC vs. Marijuana for glaucoma and nausea treatment, for one. Numerous other examples exist -- check out some of the patents granted to the pharmeceutical industry recently, based on folk-cures from Indonesia to Brazil which have (had?) been in use for thousands of years, and are now the sole intellectual property of various drug companies, who will let you use it, for a monopolistically high price.

Regulation can be a good thing and is sometimes necessary, but it has a side which grows ever uglier the greater corporate influence comes to dominate the regulating institution, namely our state and federal governments, and (even when justified and necessary) regulation always carries a heavy price.

Local Pharamies with Local Websites.

A clear problem with this legislation is that it ignores the possibility that neighborhood pharmacies might use the Internet/WWW to serve their local customers. We often get carried away with the Internet's ability to "globalize" and forget that it is a suitable tool for servering local needs as well.

A neighborhood pharmacy might, for instance, setup a website so that regular customers can place perscription orders on-line and recieve email notification or instant messages when the perscription is ready to be picked up. They might also make arrangements with the local clinic or doctors.

This legistation would require website that provide strictly "local" service (local to a single neighborhood) to be federally regulated. This seems to largely tip the scales in favor of large national providers of drugs.

Why not?

Now, I'm sure all the states'-righters out there will have problems with this, but in my opinion, there is nothing wrong with this legislation. I don't have widespread knowledge of the workings of other states, but here in NC, it is illegal to purchase perscription drugs without a perscription from a licensed medical practitioner (for the most part, read doctor).

As stated, the purpose of this legislation is to force online medicine retailers to obtain a valid prescription before selling the drug to the customer. This is the way all drug stores (as opposed to e-drug-stores [this e- crap gets ridiculous sometimes:) ]) work. If they violate this practice, and get caught, they are in deep doo.

In my opinion, this legislation simply requires that online sellers play by the same rules. On the other hand, I'm not sure how they plan to verify a patient's prescription. Do you have to mail them a copy of the paper-prescription? What happens if it is lost in the mail? Do you allow scanned/faxed copies? How do you prevent forgery in those cases?

Personally, if I get a prescription for medicine, I assume my doctor wants me on it as soon as possible. I'm not going to wait for a prescription to get to the retailer in Outer Mongolia (or wherever ;->), wait for verification (if that indeed is part of the procedure), wait for Bubba to go to the warehouse, search for the medicine (you don't expect them to pay licensed/trained pharmicists do you?) and ship it to you. I'll pay a few extra bucks to get it filled in the store in about 15 minutes.

In short, I think this is a good idea, but as is the case with all good ideas, it need a good implementation plan for it to be universally accepted.

Eric

I don't think that's the point

I don't see how my chances of getting the wrong drug are any greater just because some verification is made that I have a prescription.

Because if you have a prescription presumably a doctor gave it to you. Assumption: A doctor is more likely to know what drug you need (if any) than a randomly selected person.

The reason this measure is necessary is that there are a lot of idiots out there who want to self-prescribe Prozac or Ridlin or Viagra or something. I think a BETTER measure would be to give the USERS licenses. Here's the kind of scheme I envision:

Person A is born and has no licenses. At age 8 he is given a test.
Tester:"Johnny, pour this hot coffee in your lap".
Johnny: "No."
Johnny then receives a "Can Eat At McDonald's" license.

The applicable test in this case would be given around age 12/13:
Tester: "Janey, take this pill."
Janey: "What does it do?"
Tester: "Cures your condition."
Janey: "What condition? And how?"
Tester: "Just take the pill."
Janey: "No."
Janey now has the "Can Purchase Prescription Drugs Without Body Cavity Search For Perscription" license.

Other licenses include:
"Can View Uncensored Internet" (test involves knowing the difference between instructions for making a bomb and a bomb itself)
"Can Play Violent Videogames" (test involves knowing the difference between fantasy and reality)
"Can Make Right Turn On Red" (test involves being able to recognize oncoming traffic)
---

Two points...

I almost hate myself for saying this, but I believe we need to enforce restrictions on controlled substances in this country and around the world (OUCH! That hurt.)

I was a security guard at Ciba-Geigy, a pharma^H^H^H^H^H^Hdrug company, among other chemicals. The place I worked actually concentrated on dyes. Anyway, we would often get calls at the guard desk from people who needed 'emergency supplies' of one drug or another that had certain 'side-effects'. These callers usually got 'irrate' when we tried to explain that we had no way of helping them (usually by saying that they needed to see their doctor).

My brother-in-law just spent Christmas Eve driving around town to various crack houses looking for his adolescent neices father. When the dirty bastard showed up, he had spent every penny he had (which was given to him to buy the child a present) on crack. I can't believe this would happen without the addictive nature of the drug. I enjoy a cigar now and again, but I wouldn't trade the Christmas morning look on my boys' face for one. Drugs like crack can't be handle by normal humans and the government has a responsibility to protect.

I detest government regulation, but in this case I see the collateral damage of a free drug society being worse than federal intrusion. The FDA should have the power to watch over the online drug stores to insure that they don't become online drug pushers.

Re:Prescriptions should be abolished (NOT)

Various drugs should indeed be restricted to prescriptions. If every time we got a sniffle and grabbed anti-biotics, whether they are needed or not (i.e. a virus) then we just encourage antibiotic-resistent bacteria (which are very nasty, as my sister just had surgery since antibiotics no longer work).

I'm sorry, but for my own health I don't want my cube neighbor going down to the local pharmacy and buying antibiotics for the flu. There are specified doses of various drugs which vary based on age, weight, and family history. If drugs were unregulated we'd have a nightmare on our hands. There'd be lots of ODs and other problems.

As for antibiotic resistant bacteria, they are becoming more and more common, especially in countries that overprescribe antibiotics.

FDA pushes internet growth out of USA

There's a fundamental problem here... what about every website that's run OUTSIDE OF THE USA?

I predict we'll see more and more of this internet regulation as government agencies slowly realize that they are unable to control or collect revenue from online business under the traditional, over-complicated, time-consuming, labor-intesive process.

How can you impose import restrictions, trade bans, tarrifs, sales tax, etc when you're dealing with encrypted transactions over the internet.

Most online business today chooses to voluntarily comply with various regulations, like what products ebay chooses to not auction, but if ebay chose to allow others to auction prescription or illegal drugs *and* it were located outside the US, what could be done?

Governments can make the rules, but can the rules REALLY be inforced? I bet that once governments start trying to enforce these rules, you'll see businesses move to small countries with the most free business environments.

If your entire business consists of 2 72" racks in a datacenter, and a local sysadmin, it's pretty easy to move your company to any country about as fast as you can propagate a DNS change.

The cold hard reality is that online businesses can use encryption and change location faster than government can figure out how to deciper what's going on and find a way to collect money or regulate.

Attempts to tax and regulate the internet will only end up driving out businesses from opressive countries. The interesting thing is that your company HQ can be anywhere, and your employees can be anywhere else.

Laws and regulations will divide into two types: those that are enforcable in the physical world, and those that are enforcable in the online world.

absolutely the Feds' realm

The power to license doctors and regulate the distribution of medicines is absolutely the realm of the Federal government. Moreover, only the Federal government can reglate this area effectively and without bias.

Let's look at the alternatives:

THE CONSUMERS: which is to say, the marketing divisions of the drug companies that stand behind these products. Whatever confidence I may have had in the wisdom of the Average Joe, is now lost in the haze of happy-feely "all natural" and "herbal" labels I see on potent chemicals like St John's Wort and various binge pills^H^H^H^H^H^H^Hweight loss supplements. It's clear that the noble consumer can be won over by smooth talk and obfuscation, all of which is fostered by large corporations that consider 10 or 20 deaths acceptable in the name of profits. "After all, nearly 90% of EZ-Thin Herbal All-Natual Weight Loss Dietary SupplementTM live for five years or more after taking our pill with only minor complications!!!! Proven at the University of Nairobi to make you smarter and more attractive!!!!!! All Natural!!!*"

*(some test subjects experienced heart failure and testicular shrinkage)

THE PHARMACEUTICALS: Don't make me laugh. History is replete with examples of powerful companies that will ignore or downplay the lethal or detrimental effects of their products in the quest for that extra $1M.

THE STATES: Essentially this is the pharmaceuticals all over again. Congressional representatives are effectively owned by Big Money, and there are few institutions with more of that than the pharmaceuticals. Why would a representative prevent a drug manufacturer, that brings perhaps hundreds of jobs to the state, from producing a dangerous drug that might not even have a very large market in the host state? The wonderful thing about the internet is that you can base your operations in Kansas and sell primarily to people in Idaho, or Washington, or vice versa.

With regards to the contention that will undoubtedly be made by some righteous libertarian or other, the Federal government enjoys this power because it is a matter of interstate commerce. Offering products for sale on the internet constitutes a nation-wide purchasing opportunity, unless the host company is unwilling to ship out of state. But in the case of prescription drugs, which carry a high profit margin, I don't think that will be the case.

Now, I do lament the loss of personal discretion that comes with the Feds assuming power in this matter. Informed individuals should have the right to choose. The trouble is that many people believe they are informed when in reality they are sadly, or even dangerously misinformed. That kills people. And it's why we have an FDA to begin with.


-konstant
Yes! We are all individuals! I'm not!

until what?

hmmm so people lik myself want no regulation
until we get a bad prescription ourselves? Hmmm
how does regulation prevent bad prescriptions?

Even without Licenceing etc all the drugs they
sell still need to be made in a manner that they
are safe to consume...if not then they are selling
dangerous product. In fact...most of the time the
drugs are made by the same manafacturer as the
normal pharmacies buy from.

Pharmacies are basically glorified pill counters
these days. Licencing doesn't prevent them from
fucking up and counting wrong. It doesn't
prevent them from picking up the wrong bottle
and giving you the wrong pills.

An online pharmacy that sold anything except what
they are advertising is still in trouble for
breaking existing laws...like say fraud.

In truth this regulation is all about control. It
is about the belief of people in the federal
government that they have the right to control
every aspect of our lives. The entire concept of
prescription drugs is founded on the idea that
citizens do not own their own bodies and do not
have the right to self medicate beyond what
Big Brother has Aproved.

Its funny how anti-drug propagandists always talk
about the "Message it sends". I don't know
about you...but I don't like the message that
these control measures send.

Re:We need less government, not more

> Pharmacists know a hell of alot more than the
> average joe about what you should and should not
> take.

Yes they do...which is why the "Average Joe"
should consult his doctor and pharmasist before
he even considers using any drug.

However what about above-average joe? How about
someone who has done personal research, read
reports, etc and decided that a drug is right
for them? What gives you or anyone else the right
to tell him that he shouldn't be able to decide
for himself? Is it not his body?

> Tell your evangelization shit to the family of
> the man who died because he bought viagra over
> the internet

How about people who took tylanol and died? Lots
of them every year. How about someone who took
a bit more nyquil then they should have and found
out the hard way that they are one of the 1%-3%
of caucasions who are missing the enzyme that
metabolizes Dextromethorphan.

The simple fact is that if you don't consult a
doctor, then its "Buyer Beware". Buying a drug
on your own means that YOU take responsibility
for making sure its not contraindicated.

Noone is to blame for the fuckup but the man
himself. He could have easily done a little
research and found out that information.

> Sure, it's his responsibility to know that, but
> not everybody is as smart as you say you are

Glad you realize that. Its why we have Darwin
Awards. If a person dies because of their own
irresponsibility, I have little pity (perhaps
for the fammily but not for him).

If you want to help out, forget regulation. Go
for Education. People SHOULD know more than they
do. Over the counter drugs account for many deaths
every year.

Believe it or not, regulation ENCOURAGES
irresponsibility. It breeds the attitude that
"Well other drugs are controlled by doctors and
pharmacists, so these must be safe if I can buy
them" so people buy them and start popping away.