OT: Product of Origin - Medicine

[Fredman]

My doctor just prescribed a generic anti-biotic Ran Cefprozil for an ear infection. A google search led me to the manufacturers web page. It appeared that this was a Canadian company, but the "About Us" shows that the company manufacturers their drugs in India. I know a lot of medications in North America are manufactured in San Juan, Puerto Rico under American standards, but this was the first time I heard of medicine being imported into Canada?

I am just wondering what folks thoughts are on Product of Origin markings, should they be on all food and drug products? I have noticed a lot of food products in Canada coming now from India, China and other countries that are not the usual import foods, things like pickles.

Here is the reference for the Ran Cefprozil
http://www.ranbaxy.ca/English/aboutus.asp

Ranbaxy Pharmaceuticals Canada Inc. (RPCI) is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India 's largest pharmaceutical company. RPCI is the first India-based pharmaceutical company to enter the Canadian market and the latest affiliate to join the Ranbaxy family of companies around the world. RPCI is engaged in the sale and distribution of affordable generic medicines in the Canadian healthcare system. Ranbaxy's R&D efficiencies and globally integrated systems enable RPCI to develop and manufacture pharmaceuticals to be brought to market quickly, efficiently, and at lower costs. As a result, we anticipate making a meaningful contribution to the healthcare system in Canada, as in other countries where we have done business.

Therapeutic Products Directorate (TPD) has already granted approval to RPCI to market a number of products in Canada.

[SaltLakeJan]

Hi Fredman:

This is one of my favorite gripes - in fact I could turn it into a rant in about 2 seconds.
I have looked up some of my generic drugs and it has been impossible to know where they are manufactured. I could tell where their Home Offices were, in New Jersey. But all I could find, was their web site. Their CEO and general offices, that they were recruiting professional sales reps - but not a word where their product was manufactured.

I live in Utah, and one of our Senators, Orin Hatch, has Town Hall meetings. I was sufficiently steamed about wanting to know where our drugs are made, and under what conditions - I went to one and asked him. My answer was:
'That was a great question, and one we will be taking up in Congress this session." It was last summer before the economic meltdown - I will bet dollars to doughnuts that it never saw the light of day.

I have a habit of bugging him by e-mail. I get a very nice answer from a subordinate, I have volunteered in some of his large seminars in Salt Lake. He recognizes me by sight, but couldn't remember my name in a million years.

With all the scandels in China concerning food - toys etc, I dislike the thoughts of the medicine I take to keep me well, being manufactured in some dinky, dirty plant somewhere. But United States owes China so much money, I don't think any Senators are going to be questioning their how their factories operate.

I'll bet you get 100 posts, at least, on this subject.

Jan

[DreamStalker]

Hi Fredman:

This is one of my favorite gripes - in fact I could turn it into a rant in about 2 seconds.
I have looked up some of my generic drugs and it has been impossible to know where they are manufactured. I could tell where their Home Offices were, in New Jersey. But all I could find, was their web site. Their CEO and general offices, that they were recruiting professional sales reps - but not a word where their product was manufactured.

I live in Utah, and one of our Senators, Orin Hatch, has Town Hall meetings. I was sufficiently steamed about wanting to know where our drugs are made, and under what conditions - I went to one and asked him. My answer was:
'That was a great question, and one we will be taking up in Congress this session." It was last summer before the economic meltdown - I will bet dollars to doughnuts that it never saw the light of day.

I have a habit of bugging him by e-mail. I get a very nice answer from a subordinate, I have volunteered in some of his large seminars in Salt Lake. He recognizes me by sight, but couldn't remember my name in a million years.

With all the scandels in China concerning food - toys etc, I dislike the thoughts of the medicine I take to keep me well, being manufactured in some dinky, dirty plant somewhere. But United States owes China so much money, I don't think any Senators are going to be questioning their how their factories operate.

I'll bet you get 100 posts, at least, on this subject.

Jan

It is called unregulated outsourced free market trickle down economics ... where the money profits are skimmed off the top by corporate CEOs and the product crap and repercusions trickle down to the common Joe/Jane.

[Slinky]

Yeah, Reaganomics, the trickle down theory (pee on the peons), the more you owe the richer you are. And he is considered a great President by some. Snort! Reaganomics made the rich richer, the poor poorer and the middle class moving lower.

And I agree w/you, I do NOT want to ingest ANYTHING made in China! I'm not gonna put up a big stink about other Chinese products in recognition of our debt w/them but PLEASE I REALLY, REALLY do not want medicine or food stuffs made in China in my kitchen cupboard or medicine cabinet!!!!

Ha! Congress is more concerned about their own financial comforts than the American people, that content law isn't gonna come into being - except maybe at state level if the states can manage it. The state legislators aren't quite so far removed and out of reach of the people.

[-SWS]

Well, quite honestly it never occurred to me to think about what kind of off-shore manufacturing circumstances produced my generic prescriptions. In the back of my mind I apparently made a vague and simple assumption that all pharmaceutical manufacturing is bound by adequate regulation of various quality controls. My vague and admittedly unqualified assumption was that the FDA (and similar regulatory agencies in other countries) would have imposed those adequately "tight" quality-controls on the manufacture of all imported pharmaceutical prescriptions.

So the considerations discussed so far in this thread are a most interesting eye opener. Thanks for the discussion so far. As a consumer of multiple generic-prescriptions, I will be following this thread and its topic with great personal interest.

I hope to learn people's opinions and facts regarding how well or poorly controlled off-shore manufacturing of imported prescriptions might be. And regardless of those discussion outcomes, yes, I absolutely think patients deserve to know product-of-origin----so that they might choose according to their own preferences, values, and perceived risks.

Again, thanks for all the past and ensuing discussion in this thread.

[Fredman]

I found these two articles of interest from the FDA and Department of US Health and Human Services. I encourage you to read the complete documents. These are only excerpts and the emphasis is added by me - statements I found of interest. Basically, the US government is aware of risk associated with importation of drugs, legally and illegally but are working with countries to ensure safety.

As I said, my prescription pills came from India, my country, Canada - it's health regulatory branch is satisfied I guess with the manufacturing plant located in India and that the active ingredients are pure and safe. I still don't feel safe!

An excerpt from:
The Report on Prescription Drug Importation
Department of Health and Human Services
December 2004 http://archive.hhs.gov/importtaskforce/Report1220.pdf

"We recognize that there are different categories of “imported drugs” that potentially have different levels of associated risk...The conclusion of Congress reflected in current law is that the safety and effectiveness of imported drugs can only be assured for drugs legally imported into the U.S., as described above. In these cases, the chain of custody is known for a U.S.-approved drug manufactured in an FDA-inspected facility using FDAapproved methods as it travels through the U.S. distribution system. Much of the current public debate about the safety of broader importation comes down to issues regarding the additional oversight authorities, resources, and foreign government support that would be needed to assure the safety and effectiveness of other types of drugs, principally foreign drug purchases from international internet operations that are not subject to FDA’s regulatory oversight."

FDA - an excerpt form:
Imported Drugs Raise Safety Concerns http://www.fda.gov/fdac/features/2002/502_import.html

Benefits of a Closed System
Under the FD&C Act, the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes importation--bringing drugs from a foreign country into the United States.

Drugs sold in the United States also must have proper labeling that conforms with the FDA's requirements, and must be made in accordance with good manufacturing practices.

As part of the FDA's high standards, drugs can only be manufactured at plants registered with the agency, whether those facilities are domestic or foreign. If a foreign firm is listed as a manufacturer or supplier of a drug's ingredient on a new drug application, the FDA generally travels to that site to inspect it.

After the FDA approves a drug, manufacturers still are subject to FDA inspections and must continue to comply with good manufacturing practices. "With an unapproved drug, you can't be sure that it has been shipped, handled, and stored under conditions that meet U.S. requirements," McCallion says.

Along with legal requirements on manufacturing, U.S. pharmacists and wholesalers must be licensed or authorized in the states where they operate, and limits on how drugs can be distributed lessen the likelihood that counterfeit or poor quality drugs will turn up. It's because of such safeguards that the process of getting drugs onto U.S. pharmacy shelves is commonly referred to as a "closed" distribution system.

[-SWS]

I can very easily believe highly-uncontrolled and illegal importation of all those internet-spam supplied drugs are prone to heightened risk factors.

But so far I don't have a good feel for how potentially problematic my agency-regulated and legally-imported prescriptions might be. Short of good investigative evidence---either anecdotal or empirical---I'm still inclined to think that I am genuinely safe.

But as you can tell from my previous post, I haven't exactly gone looking for evidential facts either...

[Fredman]

I can very easily believe highly-uncontrolled and illegal importation of all those internet-spam supplied drugs are prone to heightened risk factors.

But so far I don't have a good feel for how potentially problematic my agency-regulated and legally-imported prescriptions might be. Short of good investigative evidence---either anecdotal or empirical---I'm still inclined to think that I am genuinely safe.

But as you can tell from my previous post, I haven't exactly gone looking for evidential facts either...

Yes you are right SWS. Finding good evidence is a challenge - one that I don't have the time resources right now and I wonder how much evidence is out there. I am sure it is there - hunting it down is another matter.

My feelings are just that and may be not well founded. The plant in which my Antibiotics are made may meet or even exceed US and Canadian standards.

Regulatory standards are important if not imperative, but it staggers my comprehension the system, the people required, expertise etc, that it takes to ensure our safety - certainly a costly venture. There will be cases where problems will arise causing great concern about the system whether it is closed or open - hopefully not at a consequence of someones death or serious injury. Part of being a human in this world, we aren't perfect.

This is a similar situation - open vs. closed systems of importation that rocked the US and Canada - Mad Cow disease. The final outcome did show that on both sides of the border was a greater need to track the origin of each animal by tagging and entering all details of that animal so if found to have any condition that could effect humans by consuming it, the animal could be traced back to it's country of origin and even to the farm where it was born including any moves to other farms.

I guess I will continue with my medication until done. It seems to be working. But I still think we should have product labeling of origin - especially in this globalized marketplace.

[DreamStalker]

The real question is ... Is the FDA appropriately staffed/funded to protect us from outsourced generic drugs ...or food products (or even US non-generics and food products) ?

http://www.modernhealthcare.com/article ... /903279997

[kteague]

The FDA's approval of a particular medication's formulation is not a guarantee that the approved drug is not compromised in production. I take the meds I need because... I need them. Doesn't mean I have confidence in what I'm taking. I can't help but be concerned about meds being made in a country that has issues with toxic chemicals in baby formula and lead laden baby toys. But look at the issues the U.S. has with food safety. Manufacturing of any product is a business, and there will always be greedy people willing to jeopardize public safety for profit. Don't know that any amount of policing will totally prevent that, we can only try.

[-SWS]

The FDA's approval of a particular medication's formulation is not a guarantee that the approved drug is not compromised in production.

Well, those FDA regulations with statistical and other unattended quality-controls are clearly going to impose some lesser risk than wildly unregulated Internet-based drugs. In this discussion, I also don't think we have a good feel yet for whether an FDA-regulated off-shore pharmaceutical factory poses a significantly greater risk than the domestic equivalent. The same controls are supposedly employed in both manufacturing scenarios. Human factors such as workplace complacency or greed are global realities manifested in every country.

But this has admittedly been a central issue in the back of my mind since this thread was opened:

The real question is ... Is the FDA appropriately staffed/funded to protect us from outsourced generic drugs ...or food products (or even US non-generics and food products) ?

http://www.modernhealthcare.com/article ... /903279997

[kteague]

Agree on all points.

[Slinky]

Yup, FDA regulated just doesn't instill a whole lotta confidence in me: 1] given the current food contamination the last few years, 2] its a government agency and my faith in my government is zilch.

We have poor immigrants from many companies working these food processing jobs because Americans don't want - or at least until recently didn't want - them. Most of these immigrants come from poorly developed countries w/o the sanitation we take for granted in this country. Their personal sanitation standards are not ours. They sanitary standards haven't been instilled in them since birth. Yet they are handling our raw food stuffs.