Should Drugs Carry Country-Of-Origin Labeling?
In the aftermath of the Heparin controversy, a zillion questions are being asked. And one involves greater disclosure concerning the origins of those materials used to make drugs. As Melinda Beck points out in her health column in The Wall Street Journal, the FDA requires drugmakers to disclose only the name and place of business of the manufacturer, packer or distributor of prescription medications. Active and inactive ingredients must be listed on the label, but not the raw materials or their origins, which are considered “commercial confidential.”
PhRMA argues that making such info public would be neither practical nor helpful to consumers, and that what counts is that any med sold in the US must meet Good Manufacturing Practices set by the FDA, Beck writes. “The requirements, if it’s made in Nutley, N.J., or a foreign country, are exactly the same,” says Lori Reilly, PhRMA’s vp for policy and research, tells her.
Whether greater disclosure would help isn’t clear. “The devil is in the details,” Peter Lurie of Public Citizen, the consumer advocacy group, tells Beck. “Would you list the finished product, or the raw ingredient or the raw-er ingredient?”
Of course, what consumers will do with such info is unclear. But as we’ve learned, the FDA can’t inspect all those facilities. Whether Congress ultimately provides more resources remains to be seen. So for the moment, the idea of greater labeling is getting kicked around. What do you think?
Should drugs carry country-of-origin labeling?
- Yes (85%, 74 Votes)
- No (15%, 13 Votes)
Total Voters: 87
Loading …
Jack2
People shouldn’t read a list of ingredients and automatically judge an ingredient as inferior because it’s made in a specific country - or not made in the US - what matters are the standards used when it’s made.
Plus it doesn’t happen with food. When I eat a Jolly Rancher, do I have any idea where the corn syrup came from? No.
I’m not worried about this. This will never happen, nor should it.
Dan
Usually, the country or place of origin for meds is Ireland or Puerto Rico for tax reasons.
James
Jack, why shouldn’t I have information, and they I can make my own decisions? Why should you decide on what I base my decisions?
The standards aren’t standard right now, as evidenced by the pet food, heparin et al events. The GAO said it would take the FDA 18,000 years(!) to inspect all companies that export food to us.
Since the cops can’t be everywhere, I should be able to choose what neighborhoods I go into. Even if the law is the same everywhere, I know some places are safer to go that others.
My options as to where I put my body, or what I put into my body, should be the same.
Jack2
Thanks for asking James.
First, if you’re in a hospital you’ve got close to no control about where what you take/use is, let alone where it comes from.
Second, you can call the company and find out where the ingredients come from. There’s no reason, we, as a society, need to pay to put this information on the label and ship all this extra useless information out for the minority of people who care.
Third, you eat pounds of food a day, and even if you take a lot of meds you’re not ingesting pounds of meds. We don’t put the country of origin on food now.
Fourth, emotionally, I think anyone who wants, or would use, country of origin information is going to make a prejudiced decision. It reminds me of not hiring someone because (s)he’s white/black/other. Granted, ingredients don’t have feelings, but people who make them depend on their jobs.
Fifth, China manufactures more goods than any other countries. So even if most defective manufactured goods come from China, it doesn’t necessarily mean the odds of getting a bad product from China are any different.
Sixth, it would be logistically difficult, as mentioned in the article above.
Bingo
The country in which the finished dose is manufactured is very often not the the same as the country in which the active ingredient is made. Active ingredients are made using key intermediates that often have another source country. Which one is the “country of origin” for the purposes labelling? What about products with more than one active ingredient?
Because cGMP compliance varies widely between facilities within a country, simply knowing the active ingredients come from a certain country tells you relatively little, and knowing the country of origin for the finished dose tells you next to nothing.
Dingle
I’ve been to some pretty scary international pharma sites. If I were taking a drug, I’d like to know where the API was manufactured. Sometimes I question if the pharma companies truly know, since supply chains are usually complex and sourced from multiple paths.
Just because Ireland and PR are great for tax (Singapore is better), doesn’t The tax haven is often just one or two steps in the chain.
I’d be a lot more concerned about this if I were taking a generic (and wondering if it were actually a placebo).
CMC guy
I’ve been to a few pretty scary domestic API manufacturing sites so location is not always a direct gauge of quality, even if they have passed inspections by FDA and multiple clients (extrapolating rationale my take with limited data suggests we should purchase from Swiss). ICH Q7 probably has helped raise standards overall and level international comparison. Systems should be in place to trace materials and sponsors do bear responsibilities in assuring materials appropriate but although not an excuse reality is that Quality groups are often stretched thin so focus on late stages with less examination of early/pre-steps.
Are people willing to pay additional for “made in USA” or the increased internal & external (FDA) resources necessary to fully maintain highest levels of quality?
Callie Roberts
This is a joke—right? Label what? The active, excipient, dosage, or package. What integrity assurance does a “country of origin” offer, really!. Counterfeiters will be counterfeiters. Didn’t we cry about this when GM implored us to buy “made in america” autos?
Steve
The marking requirements under the FDA Regs. and the Customs Regs. are very different. FDA requires the product to be labeled with the place of “manufacture” where Customs requires the product to be marked with the country where the last “substantial transformation” took place (when more than one country is involved). Determining substantial transformation is subject to statutory interpretation and, in some cases, construction. Ultimately, it means virtually nothing to the average consumer.
Kelly
I agree with Dingle and CMC guy - having been in and out of many pharma plants, I have a heiarchy rule of which drugs I am willing to take. I never use generic. I’d like very much to know where my APIs come from and I would rule out all made outside of the US or EMEA, if I could. And I NEVER take a new drug - I have no desire to be part of the Phase 4 clinical study, otherwise known as “unleash it on the public”. The underfunding of FDA is one of the government’s biggest crimes against the American people IMO.
Just A Thought
What I wonder about production origin.
When a drug is being submitted to the FDA for approval, is the application based on studies of that drug manufactured in the country where it will be made?
Or if the drug’s production is moved, does the manufacturer have to submit the results of a new clinical trial?
Can’t humidity and temperature effect things like frailability, shelf life, wet or dry granulation, tablet compression, dry lubrication, etc..
Things that have to do with how excipients are made, held, and used. Things that can alter a drug’s dissolution?
Just asking.
I want to know where my drugs come from.
billy bob
I think this topic is unrelevant to any thing imporatant so get a a life
Joe
JACK (off) said:
“Third, you eat pounds of food a day, and even if you take a lot of meds you’re not ingesting pounds of meds. We don’t put the country of origin on food now.”
Actually, we do put the country of origin on foods. Further, would you rather take a medicine manufactured in Ghana or in the U.S.? China has a long history of suppling drugs that have none of the (expensive) active ingredient, essentially placebos, which have resulted in death.
Stop defending the drug companies and start looking out for the people.
Baxter already has dirty hands in blood meds. Back in the 80’s they were involved in getting blood samples from prisoners for use in creating clotting drugs for hemophiliacs. They didn’t screen for AIDS and wound up infecting over 4,000 patients with AIDS.
Joy Ramsey
The big question here is why don’t we just manufacture all drugs in this country and pay the additional cost for safe drugs. Right now, the departments of our government can’t protect us or our animals from consumer terrorism, let alone the kind that blow us up. We should get back to making things in our country. It’s a matter of national security for so many things that we use or need. This use to be a great country, for those of you under 35, you don’t remember; now it is mediocre and we have the politicians to thank for that. As voters, we need to clear the deck every election. One term in the senate, two in the house and you are out. Maybe someone besides a lawyer will run for office then.