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Dr. Bob is Robert Hsiung, MD,
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Posted by Phillipa on January 23, 2015, at 21:06:50
Just got this alert. Seems European Nations has taken action on a lot of generics. FDA not so. Phillipa
News Alerts
Suspend Dozens of Drugs Based on Flawed Studies, EMA Says
Robert LowesDisclosures
January 23, 2015A committee of the European Medicines Agency (EMA) has recommended suspending the sale of roughly four dozen generics for conditions such as diabetes, depression, and hypertension because their approvals were based on flawed clinical studies conducted in India, the agency announced today. The US Food and Drug Administration (FDA) has not yet taken action on the issue.
Familiar names on the list include candesartan, donepezil, escitalopram, esomeprazole, and metformin. The list extends more than 120 pages because the drugs are marketed individually in multiple European Union (EU) nations in various dosages, and therefore appear over and over.
Abbott Laboratories, Actavis, Dr Reddy's Laboratories, Mylan Pharmaceuticals, Sandoz, and Takeda Pharmaceuticals are some of the many manufacturers involved.
The EMA recommendation to suspend the drugs would apply across the entire EU. Drug regulators in France, Germany, Belgium, and Luxembourg have already acted to stop the sales of 25 drugs.
The clinical studies in question were conducted by GVK Biosciences, a contract research organization in Hyderabad, India.
The recommendation of the EMA's Committee for Medicinal Products for Human Use to suspend the drugs was based on a French inspection of GVK Biosciences that revealed "data manipulations of electrocardiograms during the conduct of some studies of generic medicines," apparently over the course of at least 5 years. The systematic and prolonged nature of these manipulations and the number of staff involved "cast doubt" on the integrity of the trial methodology and the reliability of the data generated, said the EMA.
However, "there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences."In a statement posted on its website, GVK Biosciences called the EMA recommendation "unprecedented and highly disproportional." It said that the EU agency had extrapolated findings about the suspect electrocardiograms in nine studies to all studies conducted at its Hyderabad facility. The company quoted French inspectors who said that the electrocardiograms "are not essential given the demonstration of bioequivalence," and that their observations should not be extrapolated to the bioanalytic, pharmacokinetic, and statistical aspects of its research.
"GVK [Biosciences] is working closely with its customers to ensure an appropriate and quick resolution to these issues," the company said.
FDA Has Taken No Action After Its Own GVK Inspection
Medscape Medical News asked the FDA to comment on the EMA recommendation. It received a statement that the agency had released last month after the decision of several EU nations to suspend sales of various generics. In it, the FDA said that some 40 drug applications received from 2007 to March 2012 contained GVK clinical data, and that some of these applications were approved.
The FDA declined to identify the drugs in question or indicate those that had been approved.
According to the FDA statement, the agency inspected GVK Biosciences in September 2014 on the heels of the French inspection in May 2014 and failed to find any evidence "that affects the safety or efficacy of drug products subject to pending applications or products approved in the US."
The agency promised to take "swift and appropriate action" to protect American consumers if it "identifies issues concerning GVK Biosciences that relate to products approved by the FDA."
Exceptions Can Be Made
The EMA investigation of drugs studied at GVK Biosciences encompassed more than 1000 individual generics in various forms and strengths as individually approved in 29 EU nations. Of this group, 300 generics had enough supporting clinical data from other sources to warrant staying on the market, according to the EMA.
That left roughly 700 generics reiterations of the core four dozen or so drugs that should be suspended, the EMA said. However, individual countries can make an exception for drugs that are critically important because there are no alternatives to meet patients' needs.
The EMA recommendation goes to the European Commission, the EU's executive agency, for a legally binding decision that will apply to all EU nations, including those that already have suspended the generics in question.
More information on today's announcement is available on the EMA website.
Posted by Zyprexa on January 24, 2015, at 3:44:24
In reply to EMA Suspends Use Of Dozens Generics Flawed Studies, posted by Phillipa on January 23, 2015, at 21:06:50
Could that be why there is a back order on my 10mg olanzapine from Teva?
I noticed teva was not one of the names on the list of manufacturers.
Posted by ed_uk2010 on January 24, 2015, at 8:54:47
In reply to Re: EMA Suspends Use Of Dozens Generics Flawed Studies, posted by Zyprexa on January 24, 2015, at 3:44:24
Hi
Thanks for posting Phillipa.
>Could that be why there is a back order on my 10mg olanzapine from Teva?
It seems very unlikely to be related.
I looked through the entire list of products (marketed in Europe) that were studied at that company. There is no brand of olanzapine on the list at all. Also, it seems that TEVA contracted out very little research to the company in question. There are a few TEVA products on the list, but not olanazapine. TEVA market olanzapine is many European countries and none of these products appear on the list. It therefore seems unlikely to me that any of TEVA's olanzapine generics were studied at that site.
Anyway, aren't you in the US? The US FDA have not recalled any medicines studied at that site. The European Medicines Agency are looking into the issue but only France, Germany, Belgium and Luxembourg have so far recalled any products. It was the French drugs regulator who found problems at their inspection. The US inspection appeared to go well.
I noticed the subject line for this thread isn't actually correct. The EMA have recommended that individual European countries consider suspending the generics on the list where alternatives exist from other manufacturers. So far, the EMA have not enforced any suspensions.
The British medicines authority (the MHRA) made a statement yesterday...
Following the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to suspend the licences for some medicines licensed in the European Union (EU) that were based on clinical trials conducted at GVK Biosciences site in Hyderabad, India, Dr Samantha Atkinson, Deputy Director of MHRAs Inspection, Enforcement and Standards (IE&S) Division said:
This is a precautionary measure. There is no evidence to suggest that these medicines are not safe and effective and people should continue to take their medicines as prescribed.
This recommendation will now be considered by the European Commission and it will make the final decision as to whether the suspensions should be imposed. If the recommendation is adopted by the Commission, we will work with our colleagues at the Department of Health to ensure people have access to the medicines they need.
Personally, I expect the British authorities will decide to remove those generics from the market where alternatives are available, pending further study data. Where alternatives are not available, I think they will keep the products on the market and request further studies ASAP to check the data originally generated at GVK Biosciences.
Posted by Zyprexa on January 24, 2015, at 9:26:54
In reply to Re: The EMA haven't enforced anything....yet » Zyprexa, posted by ed_uk2010 on January 24, 2015, at 8:54:47
I'm glade to know olanzapine's were not on the list. I read an article that said eu had stoped meds on the list untill restudied. they listed a few manufacturers that were involved and teva was not one. so I assumed that there must have been a run on teva. Don't the pills all come from one source and go to everywhere like eroupe and the usa? Thats why i was worried..
Posted by Zyprexa on January 24, 2015, at 9:29:04
In reply to Re: The EMA haven't enforced anything....yet » Zyprexa, posted by ed_uk2010 on January 24, 2015, at 8:54:47
Any idea why there would be a back order on teva olanzapine 10mg till march? at the erliest.
Posted by ed_uk2010 on January 24, 2015, at 11:35:38
In reply to Re: The EMA haven't enforced anything....yet, posted by Zyprexa on January 24, 2015, at 9:26:54
>I read an article that said eu had stoped meds on the list until restudied.
Not as yet. Only four countries have stopped distributing meds on the list so far. Because there is no evidence of patient risk, most countries are only likely to block the sale of those generics where there are alternative products from other manufacturers.
>they listed a few manufacturers that were involved and teva was not one.
A few of TEVA's products were affected, but only a tiny proportion. TEVA have clearly not outsourced very much research to the company involved.
>Don't the pills all come from one source and go to everywhere like Europe and the USA?
Not always, no. I do think TEVA olanzapine sold in the US is very likely to be the same product (but packaged differently) to the one sold in Europe. If so, that's good news because European TEVA olanzapine is not affected.
Posted by ed_uk2010 on January 24, 2015, at 11:45:37
In reply to Re: The EMA haven't enforced anything....yet, posted by Zyprexa on January 24, 2015, at 9:29:04
> Any idea why there would be a back order on teva olanzapine 10mg till march?
I don't know, but this type of situation is frequent. Likely reasons include:
1. The demand for the product exceeded TEVA's forecast (very common). The quantity to produce is always an estimate. Actual demand is very variable for generics - the result is that estimates are often inaccurate. It doesn't simply depend on doctor's prescribing, it depends on the amount of product produced by alternative manufacturers and the price at which they are selling into wholesalers and pharmacy chains. A high demand for the TEVA product could have led to them running out of stock. This may have occurred because other companies had not produced very much and were selling at unattractive prices.
2. TEVA have batches awaiting release at the Quality Control stage. Testing can be time consuming.
3. There has been a delay at the manufacturing site.
4. The manufacturer is awaiting FDA approval for some type of change, most commonly to the packaging. Changes to the actual product are far less common.
Posted by ed_uk2010 on January 24, 2015, at 11:46:21
In reply to Re: The EMA haven't enforced anything....yet, posted by Zyprexa on January 24, 2015, at 9:29:04
If you want to know the reason, your pharmacy will need to speak to TEVA's customer service dept.
Posted by Zyprexa on January 25, 2015, at 15:30:05
In reply to Re: The EMA haven't enforced anything....yet » Zyprexa, posted by ed_uk2010 on January 24, 2015, at 11:45:37
I've just never had a problem getting zyprexa or any of the other meds i take in 17 years..
What is an alternative manufacturer?
Posted by ed_uk2010 on January 25, 2015, at 16:43:53
In reply to Re: The EMA haven't enforced anything....yet, posted by Zyprexa on January 25, 2015, at 15:30:05
>What is an alternative manufacturer?
I'm sure there are many. There are certainly many manufacturers of generic olanzapine here, which is why it's so inexpensive now. I've not listed the UK suppliers because they won't necessarily be the same as elsewhere.
This is the end of the thread.
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