Congress Wants To Give FDA More Muscle

New Bill Would Give FDA More Authority In Wake Of Peanut Product Salmonella Outbreak

(CBS)  The Centers for Disease Control reported Tuesday that the number of those infected with salmonella in peanut products has risen to 677, including nine deaths. Now lawmakers on Capitol Hill are introducing legislation to hopefully strengthen the Food And Drug Administration (FDA).

The FDA ultimately traced the outbreak to the Peanut Corporation of America, but didn't catch the problem in the first place, because it's lacking legislative teeth and adequate resources, CBS News correspondent Thalia Assuras reports.

"The FDA has traditionally been a regulatory agency that responds when there are problems. And what we have recognized is that that's not good enough anymore," said Dr. Stephen Sundlof.

A Senate bill would change all that.

"The agency charged with protecting nearly 80 percent of our food supply in this nation simply can't keep up with the challenge. It's time that we make sure it can," said Sen. Dick Durbin, D-Ill.

The legislation would expand FDA access to food company records and tests, give it authority to order mandatory food recalls, and increase funding.

Lawmakers and critics say this bill is a step in the right direction, but a step that should have been taken years ago.

Latest from FDA on peanut products salmonella outbreak, related recalls.

For harbinger19

Today's News 3/5/09

In a 6-3 decision, the U.S. Supreme Court has ruled against Wyeth in the Diana Levine case, setting a crucial precedent in the battle against Big Pharma. The ruling ends an important part of the Big Pharma / FDA conspiracy racket that sought to market extremely dangerous (and even deadly) drugs while providing full legal immunity to drug companies, even when those companies actively lied about the safety of their drugs by hiding negative drug studies from the public and the FDA.

[mitch5511]

Why must it take a disaster or deaths for common sense to finally kick in?

[element51]

that's good

[harbinger19]

he FDA needs to be dismantled, it is merely a pawn of Big Pharma. "Follow the Money" should be their motto. Posted by Baileyccc
Posted by at 3:20 AM : Mar 5, 2009

If the FDA was dismantled--with no watchdog to take its place; odds are either you or your family would be dead or dying within a year. The FDA is not perfect, but on their own, companies will do anything to make a buck--including things that can kill you.

You have NO IDEA how often product must be discarded by a company due to it not being in specs or being made incorrectly. Sometimes that one batch may be worth MILLIONS--but the company does it due to the fear of the FDA. FDA now puts people in jail and holds them culpable--but if you knew how or why the FDA exists in the first place and how often companies create conditions or product that harms or kills--you would not so glibly suggest they not exist.

I don't care for the FDA because they are a pan and often they push things that are not inexpensive--but I would be one of the first in the industry to stand by the fact that they NEED to be there and companies NEED to be monitored--because without that gun hanging over their head--even most CEOs have little to no knowledge about the products they make (they are front people) and so--they would push for things to leave that could kill literally hundreds if not thousands from a single batch.

You might think the idea of dismantling them is cute--but you probably would be one of the first to bleat and/or cry if you, your family member or a friend was killed due to bad food, or bad drugs and no oversight.

he FDA needs to be dismantled, it is merely a pawn of Big Pharma. "Follow the Money" should be their motto. Posted by Baileyccc

[harbinger19]

A secondary thought here too is to ensure that all products carry a label showing the city, country, etc. of where the product was manufactured so we don?t incur the long time delays in figuring out which lot went where, no more blind shipping documents as they exist today. Wonder why this process has not been considered yet? BD
Posted by medicalquack at 10:28 AM : Mar 4, 2009


Already been done and has been done for the past 25 years. All drugs and even food has a batch number and an expiration date. The batch number corresponds to a certain batch right down to the time it was made, each time it was handled, who did what--and even when it was tested, refrigerated, taken out , re-tested, etc--there is no more comprehensive diary than what is given already for each biologic. In addition, all products have a dedicated NDC number which corresponds to potency, or MOI (multiplicity of Infection) as well as a label indicating what country it was shipped to, and every single place and person that touches it.

It takes a long time to recall because the product is NOT there. Often a recall is only on paper--the product having been long used or distributed. Companies track to a distributor who buys their products wholesale--when they recall, it is to this middle man that the recall goes--it is up to the distributor to contact all they sold product to and to ask for it back or account for it. Often big pharm also owns the distribution companies and has the sales force too--so it can be easier. Before you comment on what should be done in the drug or food industry--try to actually know what IS done--so that your remarks indicate constructive discourse and not "guessing " from a lay person. Recalls also take a very long time, because every step of the way, those who have the products or sold them, are trying to cover their azzes and before they pull product or scare customers, they want to ensure that they will not be the source that can get sued--so they stall --or in many cases, stores are so poorly managed or stocked that they may not even know if they have removed all the recalled items--after all--people often carry items around and then stick them in the most god-awful places instead of returning them where they should go.

[harbinger19]

A secondary thought here too is to ensure that all products carry a label showing the city, country, etc. of where the product was manufactured so we don?t incur the long time delays in figuring out which lot went where, no more blind shipping documents as they exist today. Wonder why this process has not been considered yet? BD
Posted by medicalquack at 10:28 AM : Mar 4, 2009
]

Obviously you know little to NOTHING about the pharmaceutical industry. There is already onstage testing and incoming testing with parameters and alerts--but here is the deal--An onstage QC inspector may inspect at least 25 to 50 raw materials in a day--in conjunction with that, continual monitoring and testing and calibration of equipment is done as well as physical inspections--BUT..if any company wanted to push through a product or raw material or ignore the potential hazard--ALL they would have to do to derail your idea is simply put in the wrong data and make sure it is within tolerance. Or plug in bogus testing results .

Do they do things like this in many companies in America? I was a systems/vendor/facility and documentation auditor--auditing everything from biotech to vet, to biologics to pharm--YES --they do falsify data --either because they were instructed to do so--or were too lazy to actually sample and pursue the real data--as for having an FDA inspector onsite--given that staging areas may comprise 10 or 20 kinds of sampling and testing going on (from serums and medias to stoppers and filters) there is NO way, one two or even 5 per plant could keep up with or monitor what is actually being done--in the end--to find out what has happened--follow the paper trail--because no matter how conniving--nobody can keep all those layers of paper straight. As for your monitoring idea--the flaw is in the reporting and your assumption that people will dilegently report the truth. Often, they don't.

[harbinger19]

The FDA does not need more authority, they need to be reinvented.

1. They need autonomy and should not answer to which ever party is in power. One of the huge failings of the FDA is that any one of them can and are fired by who ever is currently in power--this means that if the CIC and co says to look the other way and NOT to enforce the law (as happened repeatedly under Bush) then the org lets everything from samonella to toxic toys in and shrugs its collective shoulders.

2. They need to be better defined. Currently, the FDA handles inspections in conjunction with many other organizations and is split when it comes to food. For biologics (living things used to create drugs like vaccines) the FDA handles the ones for humans and the USDA handles the ones for animals. Unfortunately, what starts in an animal often ends up as food and the USDA is notorious for NOT knowing very much about cGMP or how to run a facility, contamination, etc. For the most part, they are fascinated with blueprints and legends and want the Cert of Analysis and do second tier testing, but when it comes to the actually desigining and mfg of drugs or vaccines--they pretty much do nothing--not even inspections.

As a result, most biologics are a rabbit warren nightmare are not safe, up to standards and are often rife with corruption, fraud and generally out of a state of control. If this does not matter (you think) consider that biologics facilities manufacture anthrax and a lot of bio level 4 products like rabies, equine encephlamylitis and other deadly illnesses--they also manufacture the flu vaccine, and if ever we need it, small pox and polio--among others

At any rate, the FDA has this curious policy of only hiring green kids fresh out of college and never hiring people from industry (though many leave the FDA and go to industry) they think that will keep their people from being contaminated or owing favors. It doesn't.

Instead, FDA officials are often bribed and "gifted" to death or offered really cushy salaries and jobs later--after they do numerous favors for a drug company like fast tracking a new drug or stopping/delaying generic company applications for drugs (ANDAs) What you end up with --is a corrupt inspection service who is either in the pocket of drug companies or in Congresses pocket or on a leash by the administration. (REpublicans tend to not let the FDA do their job--Dems give them too much power)

The other thing you end up with are a bunch of people at the FDA (biological and pharmaceutical divisions) who really do not know what they are doing, or what drug companies are doing--since they never did anything except get out of college and work at the FDA. Pharm. plants are huge, complex and dangerous and FDA inspectors try to walk around and pretend they know what they are looking at and how it all works. They don't. Only a few FDA people are feared or respected by the industry, the rest are humored because they don't know how to audit or inspect and except for a few glaring observations, they often wait until quite a few people in the public DIE before they come in and really start nosing around.

And how do I know all of this? Because I have had the dubious pleasure of escorting FDA inspectors around or helping them weigh through batch records (which can be stuffed full of data and be as thick as 6 to 10inches for one batch. The USDA should not be auditing any biologics or pharmaceuticals--and the FDA should hire seasoned auditors from industry and learn from them (the good ones, not the idiots with a checklist) finally--the entire org should NOT answer to the current administration and should be independent with job security. Because without it--anyone can threaten them and from the top down, they will look the other way, until --like in the peanut scandal--a lot of death has occurred.

[MalloryDavis]

Yea, yea good idea to give another government bureaucracy more power.

[whitemale08]

You can start by having the FDA ban all 'processed food'.

We don't need Wall Street greed making a buck off poisoning the American people with preservatives and replacing contents with synthetic plastics.

[drsuz]

**The legislation would expand FDA access to food company records and tests, give it authority to order mandatory food recalls, and ""increase funding.""

Yep, another Democrat, Sen. Dick Durbin, D-Ill. handing money out..Now, maybe the FDA could use it, but WILL it be used the right way. Say maybe hiring qualified people instead of lining the pockets of the head honchos????

[tincup356]

"The FDA has traditionally been a regulatory agency that responds when there are problems. And what we have recognized is that that's not good enough anymore," said Dr. Stephen Sundlof. ...............................................The FDA is the MOST corrupt department of the United States government.......If they are SO CONCERNED about our safety........then why would they accept false laboratory evidence and approve Aspartame for use in foods and drugs consumed by US citizens?......It was originally formulated for chemical warfare,,and causes many side effects which are irreversible. The sad thing is that it is being mass fed to the people and has been for 20 years,,,thanks to Don Rumsfeldt.

[medicalquack]

This is from a post I made on my blog in November, 2008, need technology to make it work, originally I thought only for imports, but we could use a reporting system right here in the US as well.

http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html


FDA to detain food shipments from China ? Why not add some technology to the inspection processes?

I don?t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both our food and pharmaceutical products is good.

One thing in particular that springs to mind for me here here is perhaps some use of business intelligence for monitoring. This is not a cure all for the entire process, but technology can aid and offer some nice assistance here. A reporting function would need to be set up to automatically report back to a central agency on criteria established for each drug or food product. At the receiving end, anything out of tolerance would be immediately sent to an alert. Now granted, this should be done locally from every plant, but when you can?t physically have agents in place at every factory all the time, this could offer some real relief and help.

With today?s speed of data transmissions, a server farm could be set up to monitor this type of activity and before an over seas factory began to export to the US, this would be a prerequisite to be established. Each lot before packaged would send the chemical content back to the central gathering agency and report in, with both the US agency and the local factory itself having the information at hand.

Again, this comes back to adding some new software and algorithms to the process, but computers could provide this information in a couple of seconds. Audit trails would also be there to allow for checking back on submissions. A bank of sophisticated server farms could do the work. This would also tend to build product credibility as well if everyone knows up front that the chemical content was being reported before the end packaging occurs. Again, not to replace an actual physical inspection all together, but, it would also stand to make those inspections much more information rich and valuable and create safe consumable products.

We do so much today by remote transmissions with information reporting, why not put in in place and use it where it is vital. This could also be done globally too, with each country receiving reports on products they import from other countries. It would sure beat some of the guesswork we see out there today, not to mention illnesses and death from products that are tainted or contaminated. With the global economy changing every day, it makes sense to know what we are getting and it is impossible to physically monitor all the systems without using some modern day technology.

A secondary thought here too is to ensure that all products carry a label showing the city, country, etc. of where the product was manufactured so we don?t incur the long time delays in figuring out which lot went where, no more blind shipping documents as they exist today. Wonder why this process has not been considered yet? BD

The FDA needs to be dismantled, it is merely a pawn of Big Pharma. "Follow the Money" should be their motto. Posted by Baileyccc

[cusefan211c]

About time, they also need to hire 20 or 30,000 new inspectors and doctors to fix the problem