Someone call?
Posted on 06/24/2008 2:02:19 PM PDT by Incorrigible
By ROBERT COHEN
WASHINGTON — First, it was inexpensive toys, apparel, footwear and electronics that flooded the U.S. market from China.
The next Chinese export to reach American consumers will be lower-cost generic versions of brand-name medicines. Although it will take at least several years before Chinese-made generics are available here in significant numbers, the prospect already is raising safety concerns, given China's history of substandard drugs at home, the recent scandal involving contaminated ingredients in the blood thinner heparin, and other safety problems, from tainted pet food to toothpaste.
"We should be concerned, because the U.S. safety nets are frayed, and China has become a poster child for problems," said Roger Williams, chief executive of U.S. Pharmacopeia, the official standards-setting authority for all prescription and over-the-counter medicines.
Williams said the Chinese are capable of meeting good manufacturing standards, and the government there is in the process of instituting better controls. Still, he said, the U.S. Food and Drug Administration will have to be very careful before giving the OK to any Chinese-made generic drugs.
Graham Lewis, a vice president of IMS Health, a pharmaceutical market intelligence company, said, "So long as the Chinese can guarantee quality and consistency of supply, they have the skill base and commercial drive to try to build a dominant position in the U.S. generic market."
"I would not underestimate their capacity in becoming a major player in the generic field," he said.
The introduction of Chinese-produced pharmaceuticals is expected to further drive down already-falling generic drug prices, offer competition to drugmakers in the United States, Europe, India, Israel and elsewhere, and put pressure on their profit margins.
Edward Thwaite, head of E.W. Thwaite Associates, a pharmaceutical consulting firm, said he expects "price competition will be severe because of low labor costs" in China.
"China will be a player, and a substantial player, but it will take some time," he said.
Lewis predicted the time frame for a significant Chinese effect could be five to 10 years. But Michael Chace-Ortiz, senior director of pharmaceutical product strategy at Thompson Reuters, said he thinks the wait is much shorter, perhaps three to five years.
"It will come in two distinct phases, as was the case with the Indian generic companies," Chace-Ortiz said. "It will start with the bigger companies that have technical know-how and financial resources to do it, and then it will be followed by mid-size to smaller companies."
Indian pharmaceutical companies, which only a decade ago sold just a handful of drugs in the United States, today are marketing hundreds of different generic medicines to American consumers.
The Chinese are currently laying out their own plans, and in some cases moving ahead.
Last summer, the Food and Drug Administration granted tentative approval for Zhejiang Huahai Pharmaceutical to sell a generic version of the AIDS medicine nevirapine when the patent held by German drugmaker Boehringer Ingelheim runs out in 2012.
This approval is thought to be the first instance in which a Chinese drug company has gained permission to export a finished medicine to the United States.
The use of generic medicines has been growing at a rapid rate, reaching 67.3 percent of all U.S. prescriptions in 2007, as brand-name pharmaceuticals in many therapeutic classes have lost patent protection. Generics accounted for $58.5 billion of the $286.5 billion in U.S. prescription drug sales last year, according to IMS Health.
Currently Teva, an Israeli company, has the biggest U.S. market share for generics, with 19 percent. It is followed by Sandoz (a company owned by European-based drugmaker Novartis), Mylan, Watson Pharmaceuticals and Barr Pharmaceuticals, according to IMS Health.
Andrea Hoflelich, a spokeswoman for the Generic Pharmaceutical Association, and Jake Hansen, a senior vice president of Barr, both declined comment on the potential effects of China's entrance into the U.S. generic drug market.
China is already the world's largest producer of active ingredients used to make both generic and brand-name medicines, and it has steadily gained market share by offering lower prices than competitors such as India.
Many Chinese-made ingredients are used in prescription drugs in the United States, and a number of over-the-counter medicines and dietary supplements consumed here are made in China.
China also has been open to direct foreign investment in drug research and manufacturing, and has attracted interest and activity from many major drugmakers, including AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Novartis and Roche.
But Chinese drug companies face a number of challenges if they want to export generic drugs to the United States, including providing proof they can manufacture safe and high-quality finished products that meet American standards.
The Chinese market has been riddled with counterfeit drugs, and its drug regulatory agency has been beset by corruption.
Last year, the government began to crack down, passing a new law to strengthen drug administration, securing convictions against a number of corrupt regulatory officials and even executing the head of its drug agency for taking bribes.
Concerns intensified with disclosure this year that the blood thinner heparin, made by Baxter International in the U.S., was contaminated with ingredients imported from China. The contaminated heparin has been linked to hundreds of serious adverse reactions, including as many as 81 deaths in this country.
Recent congressional hearings and reports by Congress’ General Accountability Office have shown the FDA does not have the resources to inspect even a fraction of overseas plants that export drugs or drug ingredients to the United States, and in many cases does not even have a complete database of such manufacturers.
The FDA has asked for an extra $275 million to ensure the safety of imported drugs and food, with a sizable portion of the money expected to be used to hire staff to inspect foreign drug plants, including the more than 800 in China that make ingredients used in drugs consumed in the United States.
(Robert Cohen can be contacted at robert.cohen(at)newhouse.com.)
Not for commercial use. For educational and discussion purposes only.
You pays your money and you takes your chances.
The Chinese market has been riddled with counterfeit drugs, and its drug regulatory agency has been beset by corruption.
::::::
China CANNOT BE TRUSTED to ship quality drugs. They are corrupt in business as a way of life. The Heparin deaths caused by their defective junk product is testimony to their total lack of quality and care about same.
Even if the Chinese can bribe enough government officials, I will never purchase a Chinese-produced generic product if it can be identified as such.
There is a great deal to like about the Chinese culture, but anyone who believes that Chinese society adheres to the same conceptions of objectivity and the truth that we do in The West is a fool.
At some point, the Chinese will determine that it is time for us to go to war. At that point, I hope I am not using any prescription drugs. We won’t quite know that a war is coming, but our people will be dieing already.
As I recall, the Bush administration was savaged for not expiditing the reimportation of drugs from Canada, many of which were Chinese Knock-Offs.
Worse than that. It's not that they produce impure ingredients. They produce ingredients doctored to pass standard lab tests. In the pet food poisonings last year, a Chinese firm sold gluten containing some compounds used to manufacture plastics -- compounds that have no nutritional value, and are poisonous in combination, but test high in nitrogen.
We need a few lawsuits against US firms buying ingredients for food or feed or drugs from China. Make the firms rethink how much they save on cheap Chinese ingredients.
What about the generics from India, like the firm Ranbaxy? Are they OK? I just got some generics from Longs Drugs her in CA and they are now using Ranbaxy, which appears to be Indian.
Any thoughts? Thanks.
Neither will I. It is not too early to start letting big pharmacy chains know how we feel about that.
I am not an expert but have had mixed results with Indian pharmaceuticals. Before Prilosec (omeprazole) was made OTC here, I had the Ranbaxy generic. It was much less effective and I had to take double the dose, but I am willing to bet that was because the particular lot was too old (could have been stored by the supplier for who knows how long). When major players are doing the import/export that shouldn’t be a problem. Other drugs such as ciprofloxin have been just fine.
Never thought I’d be asking the pharmacies... “Can I get that in Name Brand?”.
Thank you. I am on Atenolol, a beta blocker, very low dose for benign arrythmia/palpitations. It’s the generic for Tenormin. The same generic I had earlier was from Canada.
I got nervous hearing about China’s drugs so when I saw Ranbaxy on the new bottle I wondered about it and found it is Indian.
So far, I think it’s OK — I feel no different than I did before and pulse rate is not elevated so we shall see.
Ping.
50 dolla make you holla. You go now!
I asked CVS pharmacist if the medicine I got was from China. She told me all our medicine is approved by the FDA. I asked again if its made in China and she responded with the same answer as before. I felt she really did not know the answer.
It can be hard to get name-brand drugs now. I have found that my son’s acne meds are significantly less effective when they are generic. Unfortunately, the pharmacy doesn’t like to stock the name brand, and they give me a royal run-around over my insistence on the branded items. It worries me that my elderly dad is on a lot of meds, and probably most are generic. I don’t want to scare him, but I’m concerned that his cardio and diabetes meds aren’t up to snuff. Ironically, he’s a retired pharmaceutical researcher with significant clinical success to his discoveries. Now he has to worry about whether his meds are safe. I really hate the China trade . . .
Ping
I got some generic modafinil from India that works just fine. I know there are risks, but what the hell. Can’t be much worse for me than the moldy weed and strychnine blotter I encountered when I was young and foolish. The foolish part may still apply, but at least I am a productive fool. That modafinil is the best stuff ever. If they’d discovered it a hundred years ago, it would be in beverages in place of caffeine.
China is a hole. Beijing is an awful place. The pollution is stunning, the buildings ugly, the streets dirty, and the people pushy.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.