European EMA Removes About 100 Generic Drugs Involving Johnson & Johnson, Sandoz, Teva, etc.

[helvella]

I managed to totally miss this news from a couple of months ago!

I do not have any more information - such as precise products involved. Might not include any thyroid medicines.

I'll also need to check up on exactly what has happened in the UK.

European EMA Removes About 100 Generic Drugs Involving Johnson & Johnson, Sandoz, Teva, etc.

ECHEMI2022-05-23

A few days ago, the European Medicines Agency (EMA) recommended that European countries suspend the use of about 100 generic drugs.

The European EMA said in a statement that up to 100 generic drugs were recommended to be discontinued this time, mainly because after testing a generic drug from an India-based CRO company, it found that the CRO company's trial data had integrity problems and even The potential for fraud has also raised serious concerns about the Indian company's quality management system and the reliability of data on the company's website.

Generic companies affected by the European EMA’s decision include Johnson & Johnson, Sandoz, Viatris, Teva, Jubilant, Wockhardt, Accord Healthcare, Aurora Biofarma, Strides Pharma, Tillomed Pharma, Orifarm Generics, Stada, Brillpharma, Micro Labs, ratiopharm , Bennet Pharmaceutica, Medicair Bioscience Laboratories, Pinewood, etc.

It's worth noting that Synchron Research Services, which is the subject of this outbreak, is not the first CRO company to come under the spotlight for data problems. Previously, the US FDA and European EMA had targeted several Indian CROs, including Semler Research and GVK Biosciences, with similar problems with their trial data.

As was the case with Synchron, regulators also required Semler to repeat the bioequivalence/bioavailability study at an acceptable alternative study site. And last September, Synchron also came under fire from the FDA for a similar data issue.

According to the FDA's previous notice to Synchron, the regulator found the company had an abnormal and unexplained research record that indicated that Synchron engaged in practices and processes that undermined the reliability of analytical methods. The FDA said it "concluded after careful review of your company's research records that these practices and processes meant that you submitted falsified research data to the FDA."

In addition, the European and American EMA warned member states that the drugs proposed to be suspended this time "may have crucial effects in certain EU member states", such as the lack of available alternatives. Therefore, in the interest of patients, national authorities can temporarily postpone the decision to suspend the use of the drug. In addition, Member States should also decide whether the affected medicines need to be recalled within their territories.

echemi.com/cms/668965.html

[SeasideSusie Remembering]

I use Teva Azithromycin and Sandoz Bisoprolol (these brands are always given to me although not stipulated on my prescription) and am due to pick up my new prescription on Monday so I'll check.

[nellie237]

This is truly worrying. I understand India is pushing hard to substantially increase production in this area on the world markets, and I think the world is buying.

Pharmacies here buy as cheap as possible to make the most they can from the NHS tariffs, and if India is the cheapest..................

[helvella Administrator in reply to nellie237]

But they can only supply products which claim to confirm to UK standards. They can't decided for themselves whether that is the case but have to go through the MHRA routes.

[TSH110 in reply to helvella]

What if the European rules are ditched?

[helvella Administrator in reply to TSH110]

Despite everything, I do not see UK, EU and USA moving significantly apart on basic issues of plant management and quality of products.

All three are significant exporters to each other. Even some classic USA medicines, like Pfizer Cytomel, are made in the EU. And there are plenty of other examples every which way round.

The intensity and quality of inspection might vary. But I expect the standard will be fairly similar.

[nellie237 in reply to helvella]

Yes 'claim' is important. But how much checking is going on..........once every 2yrs? 6 months? There must be quite a lot of reliance on standards being met.

[helvella Administrator in reply to nellie237]

Several years ago, there was a major investigation of manufacturing facilities in India. Several were deficient in all sorts of ways.

I got the impression that it was at least partially co-ordinated across the EMA, FDA and MHRA.

Their findings prompted the intention to increase inspection but what actually happened, I couldn't say.

[nellie237 in reply to helvella]

"but what actually happened". I expect all those officials are WFH now.

[helvella Administrator]

Note that, despite brexit, this EMA notice applies in Northern Ireland.

Also, a similar issue surfaced in 2020 - but regarding Panexcell:

Panexcell Clinical Laboratories: suspension of medicines over flawed studies

News 24/07/2020

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India.

The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies. These are studies used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.

The inspectors found samples from different patients that were exceptionally similar and an instance of personnel documenting the wrong room temperature for the area where samples were being processed. These findings raise serious concerns about the company’s quality management system and the reliability of data from that site.

ema.europa.eu/en/news/panex...

[BB001]

When I read this bit

'As was the case with Synchron, regulators also required Semler to repeat the bioequivalence/bioavailability study at an acceptable alternative study site. And last September, Synchron also came under fire from the FDA for a similar data issue.'

I wondered what the result was of the study being repeated. Did it uphold the original study results, or not?

[SeasideSusie Remembering]

Just letting you know that I picked up my usual Teva Azithromycin and Sandoz Bisoprolol today, no problem.

Also, a great surprise - they have altered prescription to 8 weeks' supply instead of the normal 4 weeks. Whether that is permanent or just temporary because town is full of holidaymakers and the Pharmacy is short staffed and they want to keep us regulars away 😂 remains to be seen. I hope it's permanent 🤞

[helvella Administrator in reply to SeasideSusie]

I have seen some questioning of the (hopefully former) 28-day prescribing. Aside anything else, it means two dispensing fees which adds to the cost!

[SeasideSusie Remembering in reply to helvella]

They did only give one month's inhaler though 🙄. Can't work that one out!

I was asked if I would have an inhaler review "but the room is busy so you can come back any time for that". I said surely it would be better for the GP to review my inhaler to then be told it's an inhaler technique review to which I replied I've been taking them for any years so I know how to use them. Well apparently the Health Board requires it, why it can't be done at annual respiratory review with the specialist nurse at the surgery is beyond me, but then again I'm a simple soul 😏

I expect the Pharmacist gets a fee for doing it, so I will wait for my next review with the nurse.

[TaraJR]

helvella SeasideSusie fyi at my annual prescription review I asked if they ever changed the length of prescribing periods. I've had mine every 56 days for years. The GP said "yes I can make them every 3 months if you like if that's easier." I was slightly shocked! And it's altered accordingly on my record! Sometimes it's just a good idea to ask

[helvella Administrator in reply to TaraJR]

At an appointment some time back, the doctor muttered something about "Is two months OK?" and I simply said that as long as possible would be good for me - and got three months (84 days). I don't think he was really offering! He did say that if he made it any longer, there might be questions.

[TaraJR in reply to helvella]

Yay! I'll go with 3 months - that'll do me!

[SeasideSusie Remembering in reply to TaraJR]

We don't get a prescription review. But I'm in Wales at a pretty dire surgery so that may explain it.

[TaraJR in reply to SeasideSusie]

Don't they ever check what's going on and how you are?! And there am I going to Pembrokeshire next week for some time in my beloved Wales!

[SeasideSusie Remembering in reply to TaraJR]

No, just an annual lung check with the respiratory nurse for me but even that was put off due to Covid and they've still not restarted the "blow" tests to check lung function, just questions at the moment. Then annual blood tests for thyroid and others which could be affected by one of the medications I take for my lungs.