Give the FDA More Power to Regulate

Kerry Howley | December 14, 2007

An FDA advisory panel has rejected Merck's third request to put Mevacor over the counter, though a Merck statin has been available without a prescription in Britain for years. Meanwhile, Britain is considering making prescription-only birth control available behind the counter.

The lesson here isn't that Britain is less paternalistic regarding prescription drugs, but that skittish U.S. regulators need a third option. In the past, members of the FDA panels that opposed OTC Mevacor have said they'd be willing to consider a behind-the-counter status, which would address their concerns about patients unable to self-diagnose or unwilling to read warnings on the label. But they were never given that option; while a very few drugs are sold behind the counter in the U.S., the FDA only recognizes two regulatory categories, OTC and prescription-only. Doctors the least bit worried about the perils of self-care are always going to choose the latter.

Comments

iowan|12.14.07 @ 11:56AM|#

the FDA only recognizes two regulatory categories, OTC and prescription-only.

Just get the drug warriors to say it is a precursor to meth.

|12.14.07 @ 12:10PM|#

Doctors the least bit worried about the perils of self-care

and who would no longer earn substantial fees writing prescriptions

are always going to choose the latter

Big Nanny|12.14.07 @ 12:10PM|#

That seems so reasonable....it will never happen.

|12.14.07 @ 12:29PM|#

I don't see what this behind the counter status is?

Reading the article, they state:
"What we might pilot is a process by which pharmacists or nurses carry out a full assessment process before supplying the pill under arrangements equivalent to prescribing," he said.

How can a pharmacist carry out a "full assessment"? A pharmacists is not a doctor and not qualified to make a decision, in most cases, if a patient is in a high risk group for certain medications.

My understanding is that with something like birth control, there are certain higher risk people (albeit rare), but that determination would need to be made by a doctor after performing an exam and lab-work. Are pharmacists going to be giving physicals now?

And will this pharmacists more control over whether or not they choose to allow people to have access to drugs?

It's either safe for use over the counter or not. Adding yet another party into the mix and giving them control over my health choices, i think, is a bad idea.

In the article about the UK, it seems like its a bullshit cop-out to politically appease the anti-birth control crowd.

|12.14.07 @ 12:32PM|#

Adding:

All drugs are dangerous if not taken properly. If I fail to follow warnings about just about any OTC medication I am taking a risk and there is a potential for bad/dangerous outcome.

If it is safe to take in the recommended/directed form then it should just be OTC.

|12.14.07 @ 12:34PM|#

Don't need it anyhow as the U.S. cholesterol rate id down to an acceptable level collectively.

http://news.yahoo.com/s/ap/20071213/ap_on_he_me/diet_cholesterol;_ylt=Ao789HvbY71SsY2UTqA_8uis0NUE

|12.14.07 @ 12:54PM|#

ChicagoTom: Then what do pharmacists actually do? Surely they get paid to do more than count pills.

|12.14.07 @ 1:13PM|#

ChicagoTom: Then what do pharmacists actually do? Surely they get paid to do more than count pills.

Lamar,

I dunno exactly what they do, but they don't asses my health.

What I have noticed pharmacists doing include:

Controlling access to medications.

Answering my questions about what medications are effective for treating ailments.

Answering my questions about interactions with other drugs,

Answering my questions about dosages (frequency, what to do when If I miss a dose, etc)

They also tend to be more knowledgable about what the drug does and it's side effects than my doctor. (which makes sense since their primary focus is on drugs rather than general health)

What they are not is diagnosticians. Nor do I believe they are equipped or qualified to tell me if a specific individual is in a high risk group for certain treatments. They don't know my medical history and they don't really perform exams.

BakedPenguin|12.14.07 @ 1:55PM|#

I have a British friend who was used a lot of Veganin - equivalent to Tylenol3. She asked me to get her some when I went over to the UK, and they're sold OTC over there.

|12.14.07 @ 2:22PM|#

Veganin is sold OTC in Canada as well. You have to sign for it though, or at least you do in Ontario.

Antibiotic eardrops have the same status. They end up around half to two-thirds the price.

GILMORE|12.14.07 @ 3:00PM|#

"BTC" is on the way in the US - this has been in the works for some time. Probably will require some legislation, and will move forward in something like 2010.

Recent news regarding FDA consideration of BTC proposals

http://www.newsinferno.com/archives/2047

BakedPenguin|12.14.07 @ 3:08PM|#

Isaac - IIRC, the Brits were talking about putting a limit of 2 boxes per customer for each store. Not sure what good they thought it would do, though. Far as I know, codeine addicts are capable of walking 3 blocks to the next pharmacy.

I'd heard from a friend who's a pharmacist that there was a push to allow them to prescribe some meds, but I haven't talked to him in a while.

Juanita|12.14.07 @ 3:24PM|#

I have a British friend who was used a lot of Veganin - equivalent to Tylenol3. She asked me to get her some when I went over to the UK, and they're sold OTC over there.

Be careful, the DEA could arrest you and put you away for life if you try to bring a dangerous drug like that to the US.

|12.14.07 @ 3:54PM|#

Baked

What I didn't make clear is that in Ontario Veganin et al are in a different class of drugs between OTC and prescription. You have to go to the pharmacists window and then sign for it while Sudafed, Aspirin and the like you can just get from the shelf and pay for in the checkout (unless they've got meth-paranoia there too).

I think the pharmacist can limit how much you can buy at one time.

I though about stocking up on Veganin and Bactracin eardrops on my last trip to Canad but thought better of it.

Good thing to. I found out I was allergic to codeine the last time I got Vicodin.

BakedPenguin|12.14.07 @ 7:22PM|#

Isaac - Actually, I gleaned that they were in kind of a middle ground from your post. I suspect the Brits were moving to the same thing, especially if they were going to limit each patron to 2 boxes.

Robert|12.14.07 @ 9:02PM|#

FDA may not have the legal authority, but it already has an arrangement similar to BTC regarding marketing of thalidomide. FDA negotiated a New Drug Application (license for marketing in interstate commerce) for thalidomide contingent on its purveyor's going only thru certain restricted channels. AFAIK there's no legal authority to the restrictions, and the holder of the NDA could theoretically just ignore the restrictions and FDA couldn't do anything about it legitimately but might be able to use some strong-arm tactics against it.