Last Wednesday, I had a letter from Michael Davis, the Acting Director of FDA’s Center for Drug Evaluation and Research.
It wasn’t a complete surprise to get a letter. I’d written to Dr Davis 3 weeks beforehand about MedDRA codes for PSSD and about PSSD more generally. But his letter was not a response to mine.
Dockets
Dr Davis’ letter was about Docket No. FDA-2018-P-4088.
The figures 2018 after FDA in the title refers to something submitted to FDA in October 2018 – 3 months short of 8 years ago.
The submitted something was a petition to FDA that ‘formally requests that the FDA update the safety information and warnings on the prescribing labels for isotretinoin (commonly known by brand names like Accutane) to include a warning about the potential risk of developing long-lasting or permanent sexual dysfunction and erectile dysfunction’. [1, 2]
Eight years comes very close to a record for time-taken by FDA to respond to a petition. The only petition that beats Docket 2018-P-4088 that I am aware of is FDA-2018-P-1846, which was submitted in May 2018.
P-1846 is also a RxISK petition requesting persistent sexual dysfunction warnings for PSSD on prescribing labels.
Eight years is not just a record for length of time, on paper it breaches regulations. FDA have to respond to petitions in a timely fashion. Timely may be codified but it used to loosely mean responding within 2-3 years at the most.
FDA came close to responding in a timely fashion, apparently by rejecting the petition(s). Their hand was stayed for some reason.
Eight years opened a door to PSSD-Network (not RxISK) taking a Legal Action against FDA. A technicality allowed FDA to get this dismissed but in the meantime it generated a lot of useful publicity for PSSD.
Last week’s letter grants the Isotretinoin petition in part and denies it in others. For more on what was accepted and will change and what has been denied, see a RxISK post – probably FDA Responds to Isotretinoin Petition – that will appear later this week.
There will in short order also be several other posts linked to these developments.
Lengthy though it is, it is probably worth reading Dr Davis’ Letter if only to see if you can spot what it is about it that has us figuring it raises several substantial issues quite apart from what it accepts and what it denies.
See Davis to Healy.
Overplaying our Hand?
P-1846 was submitted to both FDA and EMA and later to Health Canada. EMA, Health Canada and other regulators like the TGA in Australia made moves to change their prescribing labels and mention (in small print) the possible persistence of sexual dysfunction after treatment stopped.
(Actually, we’ve just heard that a PSSD sufferer from Romania, liaising with the PSSD-Network, has found her efforts to get her PSSD recognized has led the Romanian authorities to discover that not all companies have complied with EMA’s 2019 notice to include mention of PSSD in drug labels).
Our hope in submitting the petitions was that inclusion in prescribing labels would give people with PSSD and Post-Retinoid Sexual Dysfunction something to point to when being gaslit by their doctors (neurologists in particular).
We almost certainly overplayed our hand. The ask was for prominent, even Black Boxed, warnings.
There are many decent people in the Isotretinoin and Finasteride communities who want these drugs banned. It is easy to understand this point in the abstract but even more so if a family member has been affected. Drugs that can cause suicide and persistent sexual dysfunction are problematic enough, if they are being used to treat life-threatening conditions, but difficult to justify keeping on the market without at the very least prominent warnings, if they are given for what can be termed cosmetic indications.
Recognition of the problem, however, has been another motive for many to get PSSD and PRSD recorded in prescribing labels. Any mention in the label gives the person affected a better footing in their dealings with doctors. Black Box Warnings might sound like they should do a better job for this purpose than some small print tucked away, but these days many doctors view Black Box Warnings as May Contain Nuts labels – something close to irrelevant.
In a close to unbelievable situation like our current dismissal of warnings, is it a good strategy to push for the two black-birds in the bush at the risk of losing a bird in the hand which regulators might be almost forced to concede if the ask is pretty modest?
Recognition of the problem will assist efforts to get MedDRA and other coding systems to embrace these conditions and will also facilitate academic publications. Formal recognition can be expected to increase the likelihood of research input that may help us understand what is going on in these medically mysterious conditions. Tardive Dyskinesia, the first drug-induced and post-treatment enduring dysfunction, was recognized 65 years ago but remains a mystery.
There is a Nobel Prize to be won here and, of course, a $100K RxISK Prize, but without a clear endorsement that these are real conditions rather than a concern of fringe groups, Prizes are not going to have the hoped for incentive force.
A Regulatory Crisis
Why an 8 year delay? Michael Davis’s letter sheds some light on this – hence our challenge to you to read it, even though you might find it somewhat mind-numbing. Skim-reading it (like someone with ADHD) rather than focusing on the minutiae (like someone with ASD) – See ADHD and ASD on RxISK – might put you in a better place to spot what has me anyway excited.
There is lots more to come about this letter – starting later this week on RxISK.
See also
- Isotretinoin and Consent
- Finasteride and Consent
- Bad Trips on SSRIs
- No Sex We’re on SSRIs
- Good Trips on SSRIs
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