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Vendors like to claim this, but the FDA clarified over 10 years ago that vendors are expected to apply security patches and other updates outside of the core clinical software. Re-certification is not required, the vendor merely has to certify that they tested the update for any effect on clinical function.

So, it's exactly like he said and no updates are allowed to be installed.

ISVs are shit at security because nothing about security is their problem. Being in healthcare doesn't change that; if anything, it makes it worse. I would expect a vendor to spend exactly zero effort on verifying security updates, and less than that on notifying customers. If it ain't a new sale, they ain't interested.

Honestly, I hope some hospital gets the balls to sue an ISV for failing to act in a timely manner for perpetually ignoring security like we all know they do. It's not going to change until someone holds them accountable. They'll just hide behind their EULAs until then, and hospitals will get the bill for letting people die because of security holes.

From the linked FDA page:

4. Who is responsible for ensuring the safety and effectiveness of medical devices that incorporate OTS software?

You (the device manufacturer who uses OTS software in your medical device) bear the responsibility for the continued safe and effective performance of the medical device, including the performance of OTS software that is part of the device.1

If the device manufacturers are forcing hospitals to run without OS patches, the manufacturers are not doing what the FDA says they should do. Maybe the FDA should change should to required. Even so, I have to wonder if there's anything preventing the manufacturers from simply maintaining a patch compatibility web page and telling the hospitals that they're responsible for the OS patches... I seriously doubt either party is innocent, but have to wonder if the hospitals are the bigger culprit.

The problem is that the FDA is requiring that the patches/updates be 'tested the update for any effect on clinical function'--knowing how FDA testing can and often runs, this probably in practice translates to 'not at all.'

If the tests are limited purely to the ones relevant and necessary, it'd be one thing, but the FDA has a well-earned rep for requiring tests that are antique and/or irrelevant. This is approximately like having somebody in upper management decide that any change whatsoever to the computers can only be done after huge, time-consuming & expensive battery of tests, and that you cannot skip any step under any circumstances whatsoever, even if you would like to know exactly how 'applying humorous sticker to monitor stand' could possibly result in software issues.

Vendors like to claim this, but the FDA clarified over 10 years ago that vendors are expected to apply security patches and other updates outside of the core clinical software. Re-certification is not required, the vendor merely has to certify that they tested the update for any effect on clinical function.

So, it's exactly like he said and no updates are allowed to be installed.

ISVs are shit at security because nothing about security is their problem. Being in healthcare doesn't change that; if anything, it makes it worse. I would expect a vendor to spend exactly zero effort on verifying security updates, and less than that on notifying customers. If it ain't a new sale, they ain't interested.

Honestly, I hope some hospital gets the balls to sue an ISV for failing to act in a timely manner for perpetually ignoring security like we all know they do. It's not going to change until someone holds them accountable. They'll just hide behind their EULAs until then, and hospitals will get the bill for letting people die because of security holes.

From the linked FDA page:

4. Who is responsible for ensuring the safety and effectiveness of medical devices that incorporate OTS software?

You (the device manufacturer who uses OTS software in your medical device) bear the responsibility for the continued safe and effective performance of the medical device, including the performance of OTS software that is part of the device.1

If the device manufacturers are forcing hospitals to run without OS patches, the manufacturers are not doing what the FDA says they should do. Maybe the FDA should change should to required. Even so, I have to wonder if there's anything preventing the manufacturers from simply maintaining a patch compatibility web page and telling the hospitals that they're responsible for the OS patches... I seriously doubt either party is innocent, but have to wonder if the hospitals are the bigger culprit.

Vendors like to claim this, but the FDA clarified over 10 years ago that vendors are expected to apply security patches and other updates outside of the core clinical software. Re-certification is not required, the vendor merely has to certify that they tested the update for any effect on clinical function.

Wouldn't happen.

First, unless it is a prominently accepted safe additive, it would need to seek approval by the FDA in order to be marketed to the public in the first place.

http://www.fda.gov/ForConsumer...

Second, part of the FDA's role is to study food available to the public not only for human consumption but most animal consumption to maintain certain health guidelines. This is done by "FDA field investigators inspect food companies, examine food shipments from abroad, and collect samples. Laboratory scientists analyze samples."

You might want to read about what the FDA says about the mercury concentration in vaccines. I suspect kids may get more mercury in their fish sticks (fish fingers) than in their vaccines.

Major source of mercury in kids these days is emissions from coal burning power plants. But that's OK.

There are plenty of devices which draw blood or fluids via suction. One example is the GlucoWatch:
http://www.fda.gov/MedicalDevi...

The problem with these devices is that they often cause skin lesions, bruising, and pain. I would rather stick with the needles.

You might want to read about what the FDA says about the mercury concentration in vaccines. I suspect kids may get more mercury in their fish sticks (fish fingers) than in their vaccines.

" the idea being to add it to shots as something to enhance the body's reaction to a foreign body"

Wrong. the "mercury" in the vaccine is trace amounts of themirosol, which is a preservative used as an antibacterial/anti-fungal agent for multidose vials of vaccines. Its inclusion in single dose vials has been almost eliminated just to placate idiots like you who think it's dangerous or don't know what it actually does.

If you stick a needle into a multidose vial and it keeps getting punctured, there is a chance of contaminants getting introduced. The themirosol prevents that.

It has nothing to do with making the body react stronger to the vaccine. You have absolutely no idea what you're talking about. Get educated:

http://www.fda.gov/BiologicsBl...

The OP was correct in that they do use adjuvants in many vaccines to promote a better response, although OP was incorrect about the thimerosal (both as an adjuvant and its safety, or lack thereof). Typically, it's aluminum or monophosphoryl lipid A used as the adjuvant.

http://www.cdc.gov/vaccinesafety/Concerns/adjuvants.html

" the idea being to add it to shots as something to enhance the body's reaction to a foreign body"

Wrong. the "mercury" in the vaccine is trace amounts of themirosol, which is a preservative used as an antibacterial/anti-fungal agent for multidose vials of vaccines. Its inclusion in single dose vials has been almost eliminated just to placate idiots like you who think it's dangerous or don't know what it actually does.

If you stick a needle into a multidose vial and it keeps getting punctured, there is a chance of contaminants getting introduced. The themirosol prevents that.

It has nothing to do with making the body react stronger to the vaccine. You have absolutely no idea what you're talking about. Get educated:

http://www.fda.gov/BiologicsBl...

This is the same old elitist bullshit being smuggled out through the back door.

Fundamentally, there are a lot of people out there who don't want Wikipedia to be part of the answer. Whatever standard Wikipedia achieves, the bar is raised at least a hook higher.

I was brought up with "Gerry Germ". This is how insanity was introduced into my grade three class back in the 1970s.

Some of my unfortunate classmates probably grew up to become the adults who try to spray the entire world with 99.9% germicidal carcinogens. Aside from the shocking innumeracy (readily vaccinated in just five inquisitive minutes wielding your dad's miraculous eight-digit calculator, during which one discovers the small difference between zero point zero repeating and 0.001 as multiplicands), there are about six other layers of illiteracy here. We have subsequently learned that our own bodies are outnumbered 10 to 1 (if you count cells) or 100 to 1 (if you count genes) by our personal Gerry Germ symbiotes.

Nevertheless, we continue to hold wacky beliefs about our standards of personal hygiene, and absolutely ludicrous beliefs about what we ingest or acquire from the external environment. Yet somehow we live.

The truth of the matter is that the vast majority of information we encounter in daily living has never been up to to the germ-free standards of my grade three Gerry Germ indoctrination.

Common sense is the human ability to walk past something yummy that's being lying on the sidewalk for an hour that you just stepping on, and not licking it off the bottom of your shoe.

Yet with information about the world, the idea is that the ignorant and uniformed are just going to stick any piece of information into their mouth that they pass by, so all information in the world needs to be currated by food-safety professionals (aka all the authors dripping with expertise and credentials who might have succeeded in authoring Nupedia before the heat-death of the local universe).

Fundamentally the reason that this cloaked nonsense in Wikipedia is lying there undetected is that it's almost entirely immaterial. If a person holds a transient belief in the Australian god Poopoocaca, how much does that affect this year's RRSP contribution level? About 0.00000001 times as much as the five minutes with dad's expensive 8-digit calculator they unfortunately bypassed as a young child.

And you know what? The lunacies these people believe make 99.9% of the content on Wikipedia look like an oasis of sanity by comparison.

Wikipedia needs to bump that up to 99.99% exactly as badly as the germicidal soap in my bathroom needs to bump itself up to a 99.99% bacterial kill rate. As if the human condition is nothing but 1000 lb sand-dampened power supplies with a -100 dB bullshit noise floor at 60 Hz.

Now if I can just find an industrial-strength soap (so far recognized as safe) to rid me tout sweet of all the preening assholes from which this elitist crap originates in the first place, I might start clicking the "buy" button.

Your question is essentially "How would we finance medical research if drug patents stopped being effective?"

The Medicare/Medicaid drug reimbursement is more than the yearly total loaded research costs for all drugs, when using the highest available academic estimate as of mid last year (estimates vary wildly, from $100M to $1.8B in for this estimate, by researchers from Lily, a pharmaceutical company). There is one non-peer-reviewed estimate that is even higher ($2.6B), but that is only for NMEs (new molecular entities),(completely new drugs), and multiplying that by all drugs approved each year isn't reasonable, as most approved drugs aren't NMEs. There's about 22 NMEs approved per year. At $2.6 billion each, that's $57.2 billion.

The 2015 federal cost of medicare drug reimbursement is $54.12B - for outpatient subsidies only. Medicaid had a cost of $63.34B (see page 184); this is presumably also excluding inpatients, as hospital costs are listed separately. These two programs sum to $117.46B, or a bit over *twice* the cost of the NMEs. Non-NME costs are much, much lower (tens of millions), and there aren't lots of them, so they don't really add up to much either.

Here's a link http://www.fda.gov/NewsEvents/... to an announcement for an obesity treatment that modifies the signals of the Vagus nerve via a surgically implanted device. The study implanted the device into two groups of patients, but was only actually activated for one group, though both groups thought it was for both. I'd say that was the use of the placebo effect via surgery.

Even with the regulations, several major brands that are considered (perhaps undeservedly) reputable were selling fakes. Imagine if there were no regulations.

Just in case anyone thinks this problem is limited to over the counter herbal supplements:

General information on counterfeit medicines
Counterfeit Medicine
Cracking Down on Counterfeit Drugs
The deadly world of fake medicine

Yes, even in the US, even with all the regulations, it happens more than most people think.

I was curious about point #1, so I looked up what the FDA has to say about regulating supplements:

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

Source: http://www.fda.gov/Food/DietarySupplements/.

It would appear to me that this is not just a New York State Law issue, but also a violation of Federal laws.

FWIW, they're apparently working with the FDA already.

Thync technology employs energy levels within the normal range of brain activity and we work with the FDA to assure product safety. Over 1,000 peer-reviewed published studies across more than 20,000 sessions further support the safety of our approach. http://www.thync.com/

And the FDA has already approved at least one such device, albeit for migraine treatment.
http://www.fda.gov/NewsEvents/...

And before anybody makes a claim to the contrary, here's the FDA definition:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Emphasis mine.

This is a medical device, and will be treated as such.

I'm sorry, you are incorrect. In the United States, you can not have any other fats other than cocoa butter or milk fat (which is in milk and is thus in milk chocolate). If you check the FDA standards of identity for chocolate: It is regulated in the United States and you can read the Standards of Identity here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=163
I own a chocolate factory so I know just a bit about this subject.

Patient counseling info for such drugs almost without exception specifically and explicitly mention the possibility of this very side effect, and the doctor or pharmacist, or both, tells you to NEVER combine it with alcohol

My doctor prescribed Ambien to me. I tried it for a month and it didn't work. Nobody warned me about the "sleep walking" or any of the other exotic side effects.

A friend of mine was taking gabapentin (Neurontin). A co-worker at work started a fight, he fought back, and they both got fired (from their non-union job). It was in the depths of the recession and he couldn't get another job; he wound up in bad shape. I called the FDA to find out if this could be due to the gabapentin, and a doctor looked it up their database and said yes, they had a few reports of gabapentin associated with aggression. I don't think it was in the patient information then, but it (sometimes) is now. The warning isn't prominent http://www.drugs.com/cons/gaba... http://www.fda.gov/downloads/D... and they emphasize the effect in children, not adults.

It's not possible for a patient to be aware of these things in a country where doctors' appointments are 15 minutes or less, they don't get paid for phone advice, and primary care practitioners are prescribing these drugs.

I am a physician who also performs clinical research. You have a naive faith in the ability of the United States health care system to collected aggregated data like this. There are a few diseases and complications which are reportable to public heath services (these are state-level government agencies) and also some mandatory reporting that occurs to Federal agencies, but it is very limited. There are some voluntary reporting programs, for example the FDA Medwatch site allows reporting of drug complications, but only a tiny fraction of them get reported.

I don't know off the top of my head, but I suspect a few of the vaccine-preventable diseases are rare enough that they are reportable. Most of the other data (specifically any data on complications) is not something that anyone aggregates. See Estimating Seasonal Influenza-Associated Deaths in the United States: CDC Study Confirms Variability of Flu to see the trouble the CDC has getting something as simple as the number of people in the US who die from influenza.

Then why the Black Box Warning, warning SPECIFICALLY of those side-effects? Then why does every single television commercial for every single SSRI (including the 'repurposed' ones, like Lyrica and Wellbutrin) contain the same warning about "Suicidal thoughts or actions" (which is part of the same Black Box Warning)?

Because the FDA through it's administrative powers, as authorized by Congress, has set a legal requirement for such disclaimers and labels for all psychiatric medicine regardless of the merit such claims. If you look at this logically people who are feeling depressed to begin with are more likely to commit acts of violence against themselves or others. With the millions of people taking SSRIs the occurrence of such things are shockingly low if one is to believe SSRIs are inherently dangerous when used properly. If SSRIs were really as dangerous as you and the media make them out to be it seems like the whole world would be committing mass suicide.

You said it yourself "...everyone's body chemistry is different so any drug can have adverse effects including but not limited to behavior" And one of the biggest problems with SSRIs, is that many doctors (particularly those not particularly skilled in mental health matters, but that still have a prescription pad), will, after prescribing the latest SSRI that the cute Pharma Rep. came in and dumped a bunch of samples of, will, after the Patient comes back and says "I don't think this is working, doctor; I feel like I'm not getting any better, or maybe even worse." will, instead of thinking of that Black Box Warning, say "Well, perhaps we need to INCREASE the dose..." Many of them will do that repeatedly, even OVER the max recommended dose, simply because they believe the literature that the Pharma Rep. left with those free samples...

Because everyone's body chemistry is different; some drugs may not be effective in certain people until a certain concentration is met within the body. There are several different reasons for this; some people's body may not metabolize the drug as well as other people or the drug may have a hard time crossing the blood-brain barrier. Also getting onto SSRIs may typically take up to 3 to 4 weeks before it begins to have an effect on seratonin levels in the brain and it can take equally as much time to get off them safely, so consequently switching drugs is not as simple as taking a different pill the next morning so as you can imagine physicians will want to make sure the drug is actually not working before going through all the time it takes to switch and all the side effects switching may put the patient through.

For myself Sertraline Hydrochloride was not fully effective until the doctor finally prescribed the maximum dose; 200mg, whereas with most people as little as 25mg to 50mg is usually sufficient.

If a physician is prescribing past the FDA's maximum dose then he could be outright breaking the law or liable for wrongful death. It is likely not the fault of a drug that has extensive double blind studies and approval from several government health agencies throughout the world. Anything is dangerous in high enough concentration, even things that are otherwise good for you.

As for big pharma; federal law and many states have laws against what pharmaceutical representatives are allowed to do. In my state it's practically illegal for a pharmaceutical representative to do anything other than tell the doctor about the drug.

I am very glad that SSRIs worked for you; but they are still far from innocuous drugs, period. Again, see the Black Box Warning.

I never claimed they are always safe under any condition but to the contrary I did say that all drugs have risks including psychiatric medicine. I think a better solution to this perceived problem would be to better regulate SSRIs and educate physicians and patients about them than to outright blame SSRIs for all the world's evils and ban them as some people call for.

Long story short; SSRIs are the product of half a century of careful research and not the evil scapegoat you and your preferred cable news channel ignorantly make them out to be.

Then why the Black Box Warning, warning SPECIFICALLY of those side-effects?

Then why does every single television commercial for every single SSRI (including the 'repurposed' ones, like Lyrica and Wellbutrin) contain the same warning about "Suicidal thoughts or actions" (which is part of the same Black Box Warning)?

You said it yourself "...everyone's body chemistry is different so any drug can have adverse effects including but not limited to behavior"

And one of the biggest problems with SSRIs, is that many doctors (particularly those not particularly skilled in mental health matters, but that still have a prescription pad), will, after prescribing the latest SSRI that the cute Pharma Rep. came in and dumped a bunch of samples of, will, after the Patient comes back and says "I don't think this is working, doctor; I feel like I'm not getting any better, or maybe even worse." will, instead of thinking of that Black Box Warning, say "Well, perhaps we need to INCREASE the dose..." Many of them will do that repeatedly, even OVER the max recommended dose, simply because they believe the literature that the Pharma Rep. left with those free samples...

I am very glad that SSRIs worked for you; but they are still far from innocuous drugs, period. Again, see the Black Box Warning.

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Nope

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

I even linked all the cited sections if you want to read a bunch of dense legalese that in no way supports your claim that FDA regs are the reason for expensive prosthetics.

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Nope

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

I even linked all the cited sections if you want to read a bunch of dense legalese that in no way supports your claim that FDA regs are the reason for expensive prosthetics.

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Nope

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

I even linked all the cited sections if you want to read a bunch of dense legalese that in no way supports your claim that FDA regs are the reason for expensive prosthetics.

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Nope

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

I even linked all the cited sections if you want to read a bunch of dense legalese that in no way supports your claim that FDA regs are the reason for expensive prosthetics.

If you have FDA regs, liability insurance, and lawyers all of a sudden it's $100k.

Nope

(a) Identification. An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.

I even linked all the cited sections if you want to read a bunch of dense legalese that in no way supports your claim that FDA regs are the reason for expensive prosthetics.

NyQuil D

Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine...

The sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine.

It's probably more of a training issue than anything. Do you want to be responsible for your employees getting the special rule for Nyquil D right?

Not to mention that you might find a number of Caribbean Lawyers that would LITERALLY eat you RAW for pulling a stunt like that.

I think the food regs require you to state if you processed a product IN THE SAME BUILDING as stuff with %insert list of common food allergens here% much less actually had bits of them in your product.

see https://en.wikipedia.org/wiki/...

and

http://www.fda.gov/Food/Guidan...

Dick Cheney had the wireless connection to his defibrillator removed just so he couldn't be targeted wirelessly. Of course, there are supposed to be regulations to ensure privacy and security on all new wireless health devices, so the FDA is not completely napping.

Being a Type 1 myself, these things interest me as well. The FDA has a nice write-up on it:

http://www.fda.gov/Drugs/Resou...

"The manufacturing of beef insulin for human use in the U.S. was discontinued in 1998. In 2006, the manufacturing of pork insulin (Iletin II) for human use was discontinued."

Title 21 of the US Code of federal regulations (21 CFR) lists all of the ingredients approved for use in the US food supply, whether for humans or animals. The US is a net exporter of corn and soy, and China is a net importer, so your example is not the best but I get your point.

More importantly, so does the FDA. They are currently working on the second draft of the proposed rules to cover verification that imported food products are produced to US standards as part of the Food Safety Modernization Act (FSMA). FSMA is the most extensive revision of US food and feed laws since the original 1938 Federal Food Drug and Cosmetics Act. One of the proposed regulations is to cover Foreign Supplier Verification, by which importers must certify (through inspections) that foreign companies are following the same rules as US based companies when producing their products for export to the US. Furthermore, the FDA plans to begin on-site inspections of foreign sites at a minimum of every 3 years. For those sites that are classified as a higher risk level, they will be inspecting every year, and only the first inspection is free. The FDA will bill the company for the cost of follow up inspections if problems are found and a re-inspection is deemed necessary.

Also, FSMA gives the FDA vast new enforcement powers. Currently, they can recommend a product recall, but the manufacturer ultimately decides. Once the act is in place, they will be able to sieze all product in the supplychain, issue recalls, and close down manufacturing sites on the suspicion of a problem. They don't need to have any hard evidence like testing data or sick people.

So until there's proof, there's no valid reason to change current practice.

Yes there is, the people you pay to make these decisions have made their decision.

First, if you bothered to read the summary, the decision has NOT been made. The bug tracker is still open to everyone.

hat one took only seconds to debunk [google.com]. The number one smartphone software in the world in terms of sales has a public searchable bug list., including open bugs. FreeBSD, which is the base of OSX and which Apple contributes heavily to, lets anyone browse all bug reports or just open ones [freebsd.org].

Those are all open source projects

So what?

Let's take another real-world example - bugs in pharmaceuticals. The FDA Adverse Events Reporting System. Anyone can post to it, and see the quarterly summaries that, btw, name the drugs involved, by generic and brand names. Here's a recent one of a possible "bug"

Serotonin-3 (5-HT3) receptor antagonist products (Aloxi, Kytril, Zofran, Zuplenz)

Serotonin syndrome

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Drug companies are notoriously closed-lipped - they're the furthest you can get from open source. Is the information on their "bugs" available to everyone? Yep. And occasionally, it makes the evening news, when a manufacturer has to stop production because of quality control issues, etc.

So until there's proof, there's no valid reason to change current practice.

Yes there is, the people you pay to make these decisions have made their decision.

First, if you bothered to read the summary, the decision has NOT been made. The bug tracker is still open to everyone.

hat one took only seconds to debunk [google.com]. The number one smartphone software in the world in terms of sales has a public searchable bug list., including open bugs. FreeBSD, which is the base of OSX and which Apple contributes heavily to, lets anyone browse all bug reports or just open ones [freebsd.org].

Those are all open source projects

So what?

Let's take another real-world example - bugs in pharmaceuticals. The FDA Adverse Events Reporting System. Anyone can post to it, and see the quarterly summaries that, btw, name the drugs involved, by generic and brand names. Here's a recent one of a possible "bug"

Serotonin-3 (5-HT3) receptor antagonist products (Aloxi, Kytril, Zofran, Zuplenz)

Serotonin syndrome

FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Drug companies are notoriously closed-lipped - they're the furthest you can get from open source. Is the information on their "bugs" available to everyone? Yep. And occasionally, it makes the evening news, when a manufacturer has to stop production because of quality control issues, etc.

They used to issue sugar pills instead, which might actually be tastier than the Pez, and more effective the way antibiotics are going.

As for the farmers - it's because giving animals antibiotics during specific periods of their growth cycle increases their growth significantly. I remember reading an article that they don't even use more antibiotics - the courses prevent enough sickness that farmers that ONLY give antibiotics to sick animals, at much higher doses, actually use just as many antibiotics.

Antibiotic use remaining stable
Increasing growth

> Under Obama, for example, a former Monsanto Exec became the head of the FDA.

Can you do a fact check on that one please?

Seriously? This is NOT a hard thing to find out. The guy's name is Michael Taylor, and he's been bouncing back and forth between Monsanto lobbyist or executive, the FDA, and the USDA for decades. Of course, on his official FDA page, you need to read to the very last sentence to find out that he was tied to Monsanto. (I'll have to give them a little credit for mentioning it at all.) I mean, really -- this is a pretty high profile thing. There's even a petition with over 463,000 signatures online to get this guy removed.

You're right about one thing, though -- he never actually became "head" of the FDA, if by which you mean the actual "Commissioner of Food and Drugs." He was only appointed as "Senior Advisor to the FDA Commissioner." So I guess he wasn't the head of the FDA -- but he was chosen for a top position, just one of the top guys who had the most influence and input to the head of the FDA.

I know nothing about this guy's personal policies or integrity or whatever. But I do agree that this guy is a perfect example of the "revolving door" of some dude working for a big corporation, then going to a government agency which is supposed to regulate that corporation, then back to the corporation, then back to the government, etc. And whether this guy is good or evil or whatever, that general trend is a bad one.

The FDA also has oversight of exported drugs and devices. They don't have to be approved for sale in the US in order to be exported, but do have to meet some requirements.

On the other end, most countries require an export certificate from the country of origin.

http://www.fda.gov/Internation...

I'm surprised they operated on you with -8. I looked into Lasik awhile back and all places refused to perform Lasik with that strong of a correction, for me they said it was PRK or nothing.

Some lasers are only approved to -5 or -6. Others are approved up to -15.0: http://www.fda.gov/MedicalDevi...
Although the doctor can always choose to do "off-label" corrections with any laser, the approved value is not a hard limit.

Chances are, if you can't get Lasik because of your prescription strength, then your cornea just isn't thick enough. It's a real concern once you get into the -8.00 and worse range, but some people have enough thickness, and others don't.

I'll tell you what -- all it'll take is the FDA causing the delay for one year of a decent cancer or heart disease or diabetes drug, and boom! They've cost more lives than they will have saved since 1938.

I feel pretty confident that such a delay won't cost more lives than the FDA saved when they delayed approval for Thalidomide http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/.

For extra bonus points -- that's what prompted Congress to expand the FDA's legal mandate to ensure that drugs are both safe and effective.

Likewise, "companies must submit studies, and the FDA must approve them, before a genetic change may be added to a food" sounds equally reasonable and yet is labeled "zealotry" by folks like the parent poster.

As a matter of fact, the FDA is already one of 3 federal agencies in the US responsible for oversight of GMO:

FDA regulates food from GE crops in conjunction with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). USDA's Animal and Plant Health Inspection Service is responsible for protecting agriculture from pests and disease, including making sure that all new GE plant varieties pose no pest risk to other plants. EPA regulates pesticides, including those bioengineered into food crops, to make sure that pesticides are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment.

What gets everyone all hot and bothered (myself included) is the erroneous perception that GMO are not regulated at all, or that they've been confirmed as unsafe for people or the environment despite all of the evidence being in opposition to that position. It is decidedly anti-science zealotry that prevents many from accepting that the scientists involved in developing and certifying GMO's have done their jobs, and done them well.

Worth modding up. For years the term "stem cell therapy" has attracted a bunch of charlatans promising cures way beyond what's currently feasible (or realistically possible). The FDA weighed in again recently: http://www.fda.gov/forconsumer...

Having said that, companies like Neuralstem are conducting actual research into regenerative medicine with clinical trials but it remains to be seen how this will work out. And there is serious medical research into cancer stem cells (CD47, etc.) that is an extension of immunotherapy using monoclonal antibodies.

So it's important to be specific. Traveling to Mexico so you can have some "stem cells" implanted in your spine and expect a magical cure...not a great idea.

Luckily http://www.accessdata.fda.gov/...

Luckily "External limb prosthetic component, Class I" aren't regulated as tightly.

As I said, I used to work in the airplane business. And if you bought a kit for an airplane and built it yourself, you can't sue the company that sold you the kit because you assumed the liability. That's why most innovation in airplanes in the US is in kit planes - commercial manufactures fall under liability, which complicates their lives quite a bit, which (perversely) discourages innovation, so many people are flying airplanes with engine designs from the 1950s.

Hand prosthetics are "prosthetic devices class I, non-significant risk devices" by the FDA.

http://www.accessdata.fda.gov/... .

Too bad the regulation is all about processing the grain before it gets picked up and says nothing about how it's handled once it is picked up.

Uh, yea, no. From Animal Food & Feeds we see that Sec.402, Sec. 342 - Adulterated food(go figure on the awkward titling) that:

(i) Noncompliance with sanitary transportation practices

If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 350e of this title.

So, yea, I'm pretty sure transporation is covered. I can only imagine the articles example of "possibly forcing them to dry and package the material before distribution" has more to do with the fact that until recently they've used non-sterile container trucks for the spent grain and it may be...a fungal risk. :)

So let the regulation read that the grain may not come into contact with a container that hauled beef byproducts. BAM, done, because nobody does that anyway. No need to spend millions.

And then a pig waste tanker is used and you'll be back bitching about how the FDA should have made more general rules...which already apply with the reclassification of spent grain as animal feed. Meanwhile, the point about spending millions has almost certainly everything to do with (1) hyperbole, (2) making the most absurd extrapolations of worst case scenario costs upon companies which have such horrible unsanitary conditions that it's a wonder we're all not dead yet from contamination risks, and (3) that just about anything in business of enough scale involves "spend[ing] millions" and so the effective cost is likely amortized into a relatively trivial cost for most companies who aren't shitholes with extant shitty practices.

But, yea, keep on your ranting because an industry spokesman (or a friendly politician with just the right words to say from an industry lobbyist friend) whose only interest is to spin *any* cost or *any* change because it's cheaper to spend a couple thousand as a industry to deride any sort of regulation, no matter how sensible, for fear it may result in more and for which as a whole it's cheaper to bribe or manipulate the public than to have some basic standards for shipping and transporting food to animals we eat.

But, yea, fuck knows that the beer producers have it so tough and are in such a wholly different world of expense that every other company that provides animal feed (and bares the marginal but non-zero) to comply with the regulation are all going bankrupt. Or perhaps it's the fact that with the regulation the spent grain now costs just that little bit more and they're suddenly not quite as competitive of a thing to sell and God knows the beer producers don't want any sort of level playing field on that. It's all about dumping what is otherwise waste on them and for which even if they can continue to sell the waste for a profit becomes a marginally less profitable venture with no real upside for them.

I mean, seriously, you spell out a clear example where a company fails to follow regulation which really shouldn't have been necessary and for which the FDA has no real teeth to enforce except with sternly written letters until something major happens--and a public like you who want the FDA to have some sort of omniscience but to only punish the people I guess at *just* the right time when things go wrong... Honestly, fuck you. The FDA can't magical enforce rules it doesn't have the resources to enforce and your shitty attitude is precisely why the FDA's budget keeps being cut. Not that I think the FDA is blam

This is all a tempest in a teapot. The FDA is proposing rules for complying with a 2011 law passed by congress to ensure food safety. Brewers had been exempt from the rule because they were able to buy off congresscritters in the past. Now they will have to keep records and conduct training to make sure that they aren't shipping contaminated waste grain to feed cows. People who love to eat cows should welcome the fact that they can be assured that their cows haven't been fed contaminated feed.
All of the hysteria about driving brewers out of business is just hyperbole. Before these rules, brewers could ship contaminated, spoiled grain to feed cows without any accountability. Now they will be accountable to make sure that they don't feed cows garbage... seems reasonable.
You can read the FDA regulation (and avoid the hysterical hype) here:
http://www.fda.gov/Food/Guidan...

I haven't heard of anyone talking about driving brewers out of business wholesale, but any increase in operating cost is going to have negative repercussions for a business, which may mean lower profits, leading to reduced employment. That's just the way these things work. Note that this could also have a ripple effect, such as increasing the price of milk, since farmers have been able to rely on this cheap and nutritious feed for a long time.

You mentioned "they could have" in your response, but I could counter with "they never have so far", which seems a more powerful argument. This practice has been going on for over a century with apparently no real trouble, and suddenly the brewers are going to poison the farmer's cattle? It seems a bit far-fetched, since after all, these are the by-products of human-consumable beverages. I'd be more apt to support this if there was a documented history of problems with this practice.

Government, by it's nature, tends to want to create more and more rules and regulations. I think that's part of the natural desire to proactively protect against problems, but it's also has slightly less noble purposes as well. More regulations essentially means the government has to grow to enforce those regulations. It's in the FDA's own self-interest to pass as many rules and regulations as it can, because then it's "business" grows. That means those in the FDA can move up their own "corporate ladder", so to speak.

Government regulations have to be viewed as a necessary evil. All but the most die-hard libertarians or anarchists would say we need no regulations, but there's always a careful balancing act that must be made between the imposed overhead of these regulations and the benefits they provide in terms of safety, reliability, and consumer rights. So, I think it's worth questioning whether the imposed cost of this new proposal is worth the imposed overhead and costs.

This is all a tempest in a teapot. The FDA is proposing rules for complying with a 2011 law passed by congress to ensure food safety. Brewers had been exempt from the rule because they were able to buy off congresscritters in the past. Now they will have to keep records and conduct training to make sure that they aren't shipping contaminated waste grain to feed cows. People who love to eat cows should welcome the fact that they can be assured that their cows haven't been fed contaminated feed.
All of the hysteria about driving brewers out of business is just hyperbole. Before these rules, brewers could ship contaminated, spoiled grain to feed cows without any accountability. Now they will be accountable to make sure that they don't feed cows garbage... seems reasonable.
You can read the FDA regulation (and avoid the hysterical hype) here:
http://www.fda.gov/Food/Guidan...

Here is another part of the label for Tripedia (specifically after the listing of autism): "Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine."
If Mercury in vaccines is a large concern of yours, have a look at this list of common vaccines with and without mercury from our friends at the FDA: http://www.fda.gov/biologicsbl...

One could check http://www.fda.gov/medicaldevi..., which was at the top of a very simple Google search for "risks of cochlear implants"

Someone with a a magnetic transceiver based device, such as the Nucleus worn by a colleague of mine, cannot even safely enter an MRI chamger. The MRI magnet would grab the magnet attached to his skull and yank him across the room, possibly fatally.

There is not in any way "consensus" that "GMOs are safe"

Again the facts say otherwise.

The consensus is that they are safe.
American Medical Association
National Academy of Sciences
World Health Organization
Chief Scientific Advisor to the European Commission
Department of Agriculture
Food and Drug Administration
Environmental Protection Agency

Scientific consensus is that GMOs are safe.

This happens all the time, some quack alt "medicine" is recalled because it actually contains a known effective drug. Most often it is "herbal" dick pills that contain the active ingredient in traditional ED medications.

Getting on the "Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA)" email list can be very entertaining:

http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm

How about instead of cost shifting and purchase pooling we actually work on what medical care costs in the first place? In the US you can got to Cook County or the US Federal court in the Eastern District of Texas and drive up a drug company's everyday costs by suing them in a class action for side effects they already disclosed before you bought their drug. There should be some sort of grand jury or board of people with a clue who decide the merit of these things before millions are spent on lawyers.

The for-profit speculative commission-only trial lawyers are a big part of service and product costs for drug companies, hospitals, clinics, doctors, nurses, and even medical assistants and medical techs. If you want to make healthcare more affordable through insurance cost changes, change the cost of malpractice insurance so that only people who actually screw up need to pay exorbitant premiums. When I lived in Illinois it was really difficult to get a doctor's appointment within six months without crossing state lines because the malpractice rates caused several of the doctors in the area to retire early or move to more sensible states.

Also, why do we have federal and state funds going into basic research at universities that gets patented and sold to corporations to turn into products? If research comes from a largely government-funded school then the NIH or someone should be licensed to then sublicense any of those patents to all comers for a reasonable fee.

Also, why do the drug companies pay the FDA to fast-track drugs? The PDUFA means that in order to get faster drug trials, the deeper pockets get faster times to market. If we're spending billions of dollars to improve healthcare, why don't we fund the FDA sufficiently to get the best drugs approved fastest rather than the most heavily promoted ones? Why don't we partner with other developed countries to do joint trials that meet the standards of the FDA and its counterparts in, say, the UK, Germany, France, Japan, South Korea, Canada, Finland, Sweden, and Brazil with all the agencies reviewing all the data and making decisions for their own constituencies rather than repeating the trials over and over?