MHRA meeting update

General Discussion
#1

Firstly thank you to @infinite, @Andrew35 and @espresso who were actively involved in the pre work and the meeting itself, to those who supplied testimonials and to those outside of the UK who expressed an interest in getting involved. .

Without the yellow card submissions, letters and emails from sufferers none of this would have been possuble.

Now to the meeting itself.

The MHRA representative was very open and it was clear she accepted that things do need to change. She will conduct the review which will take approximately 2 months. She stated its been given the highest rating.

From the scene setting Infinite provided the walk though of a presentation which was invaluable in providing pfs related factual data and information

We then gave individual verbal personal accounts of our finasteride experience.

Which was followed by a discussion around what we’re hoping to get from the MHRA going forward

It was clear that we were taken seriously. Patient feedback/interaction forms an important part of the review process. There will be investigative analysis of all related data/contact with other government departments, stakeholders and relevant agencies before any decisions or recommendations can be made.

We were advised of the MHRAs remit but also re assured that recommendations can made to other bodies etc where needed. (Obviously review findings dependant)

She also stated that she’d be happy to field questions from the wider community and that these could be brought to the next meeting which is yet to be arranged.

Overall it was a very positive even refreshing, there was no challenge or dispute.

The changes in France and work by Sylviane has also been key.A special thank you too @lacreland21

We also have the upcoming exclusive in the Mail on Sunday this weekend which will mainly be focused on the review. Thanks to those who are speakjng to reporters this week. @Tyr

Collaboration across countries, all of the on going work (which as at an all time high) may actually result in getting pfs officially recognised, ultimately leading to wider investment.

We may come out with asks in the coming weeks.
Relevant updates will provided.

Last but not least continue to submit to the yellow card scheme and to the authorities as it is essential tool that is used to identify issues

I hope I’ve captured the salient points guys but feel free to chip in. As stated many times, apologies
for any grammatical errors, because of the cognitive issues.

Regards

Ryan

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#2

Thank you so much, that is very encouraging news :slight_smile:

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#3

Merci beaucoup à vous, c’est tous ensemble que nous y parviendrons. J’espère de de plus en plus de personnes vont s’impliquer.

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#4

The MHRA have advised today that the review will now be concluded late August, they stated the reason for the delay is due to the detailed analysis and other reasons outside of their control… Further slippage was not ruled out.

As a reminder please Everyone report every symptom to your authorities, in the UK. It’s the yellow card scheme low numbers = very limited credibility and no action (understabily) . High numbers = validity and action this in part has been the reason why the MHRA review is taking place Don’t undersell this disease, report it all, we cannot complain if nothing is being done if the basics are not carried out. We are getting better at this but many still dont report sighting it doesn’t matter or make any difference.

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#5

Hey Ryan it’s Celia- will you message me. I haven’t been I’m touch because I switched phones and lost yours

#6

I received another update from the MHRA today.

Because of other dictated priorities the review outcome has now been moved to October. The lead investigator re iterated this remains a priority. Something urgent came up.

As an aside but a very important one. A FOI request showed numbers recorded for insomnia alone only totalled 3 as of 2021. This is an absolute joke but would explain why little has been done to entertain complaints to bolster warnings and shows that the yellow card scheme is grossly underutilised it also gives weight to my suspicion that you must report your symptoms seperatley for them all to get recorded. I would ask everyone on here from the UK to immediately re record all of their symptoms . I recently reported 3 suicides to the MHRA that had not been notified. One thing is for sure over reporting is certainly better than the opposite.

Please do this. It’s extremely important

I’ll keep you posted on the review front.

Regards

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#7

Hey ryan- lost your contact switching phones. What’s app me.

#8

Interesting reading. Well done on getting and audience and presenting to them, and for keeping up the contact.

The MHRA dialogue on PFS has been occurring around the same time as they are looking at Accutane (isotretinoin). If you ever have the opportunity to suggest they look at similarities, this would be helpful.

The regulators are not as smart as they seem. Whilst there are clear similarities in symptoms to anyone else looking at these problems, they may not make a link unless they are prompted.

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#9

Thanks Pete, will do

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#10

Dear All,

I’ve received notification from the MHRA today that the review has been completed and presented internally. They will be in touch shortly to discuss next steps.

I expect they’ll piggyback some of the recently released new guidance/measures to be introduced for Isotretinoin. I can provide this if interested.

I’ll keep you posted

Regards

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#11

Dear All,

I’ve received notification from the MHRA today that the review has been completed and presented internally. They will be in touch shortly to discuss next steps.

I expect they’ll piggyback some of the recently released new guidance/measures to be introduced for Isotretinoin. I can provide this if interested.

I’ll keep you posted

Regards

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#12

Great news - keen to see the review.

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#13

This is a copy of what MHRA sent out via email, recently:

Thank you for all your valuable input to the expert safety review on suspected psychiatric and sexual side effects to isotretinoin.

As you are aware, the Commission on Human Medicines (CHM) formed the Isotretinoin Implementation Advisory Expert Working Group to advise on how best to introduce the new measures into clinical practice. We worked with patients and other stakeholders including clinical organisations to finalise the implementation of the recommendations of the expert review and this process is now completed.

Today, we have published communication and educational materials to support and record informed prescribing decisions for isotretinoin.

The Isotretinoin page on GOV.UK has been updated and includes links to:

Marketing Authorisation materials

Updated Patient Information Leaflet
Updated Summary of Product Characteristics
Risk Minimisation materials which include:
Acknowledgement of Risk form
Pharmacist checklist and a
Patient Reminder card
The British Association of Dermatology materials

Patient guides (including a Medicines for Children guide for young people developed by the Royal College of Paediatrics and Child Health)
Healthcare professional resources (including training videos developed with the British Dermatological Nursing Group).
If you have any further questions, please email info@mhra.gov.uk.

Kind regards,

The Medicines and Healthcare products Regulatory Agency

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#14

Good stuff. Were the reviews for isotretinoin and finasteride done together?

#15

They were conducted separately BUT I expect there will have been some collaboration across the working groups as the finasteride review has been repeatedly delayed and then its completion has coincided with the release of the updated Isotretinoin guidance. (given the similarity of reported adverse events etc), expecting similar recommendations.

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#16

Dear All.

Had the review meeting this week.

Limited In what can be communicated at this time.

The changes will highlight the potential risks at the outset which in turn will deter consumers from taking fin.

The changes will also need to be comunicated to health bodies, prescribing clinics, etc.

Once this is done, hopefully by January, I’ll be able to provide the detail.

As always it was agreed that the yellow card scheme needs to be fully utilised. It is a key tool/mechanism for pharma vigilance. As said many times low submissions = limited action, understandably too. It weakens our case and the authorities ability to bring change. So please report each and every side, this goes for everyone in all countries. Regulatory authorities share data and communicate with each other.

Overall it was a positive meeting, I feel the lead investigator is sympathetic to the complexity and severity of this condition and is keen to do what she can, with increased reporting, stronger scientific evidence we can get more.

Isotretinoin/accutane was raised and it was stated, while they do discuss other drugs causing similar symptoms the working groups and reommendations remain seperate at this time.

It was agreed that we’ll continue to meet on a regular basis where we can push for further changes, more submissions will only help.

Thanks

Laz

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#17

Good to hear. In fairness to MHRA, they have clamped down in the case of Accutane. So, they are actually listening.

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#18

Agreed Pete, while they’re not banning these drugs they are certainly making them less appealing.

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#19

Got an update call with them Wednesday.

Any points anyone want raising

Sorry for late notice

Kindest

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#20

Can you give an idea of what is likely to be discussed?