Drugmakers are telling the UK that the law should be changed to make it clearer when they should report new info that could influence decisions about risks and benefits made by the Medicines and Healthcare products Regulatory Agency,
PharmaTimes reports. In particular, more guidance is needed on what exactly must be reported and timeframes, including clarity for the terms "promptly" and "due diligence."
The consultation was launched to discover if the current law – The Medicines For Human Use Regulations 1994 – needed to be changed, following the MHRA's report earlier this year of its investigation into whether Glaxo failed to inform it in a timely manner about info which it had on the safety of its Paxil antidepressant, knowna as Seroxat in the UK, when used in patients aged under 18.
The government decided there was little chance of gaining a conviction and so the case did not proceed to criminal prosecution. But the legislation in force at that time was not sufficiently clear or comprehensive as to require companies to inform the regulator of safety info when the drug was being used for, or tested outside, its licensed indications, says the government, in its response to the consultation, PharmaTimes writes (see back story).
There have been several European Union developments since that case, including a new clinical trials directive and legislative changes to clarify the obligation to report "promptly" any relevant safety info arising from clinical trials using products outside their normal conditions of use, PharmaTimes notes.
The European Commission is also proposing to strengthen the EU system for monitoring the safety of medicines but, given the length of time that this may take, the MHRA has committed to changing UK legislation in the interim to clarify the requirements.
The proposed changes to the 1994 Regulations will state explicitly, to ensure there remains "no room for doubt in industry's and regulators' minds," that Marketing Authorisation holders should report information from both clinical trials outside the licensed indication and arising from third countries and to provide a timescale for reporting, says the government, according to PharmaTimes.
The MHRA's review of the consultation says that a number of respondents - including the Faculty of Pharmaceutical Medicine, Wyeth, the British Association of Research Quality Assurance, the Association of the British Pharmaceutical Industry, the BioIndustry Association and the mental health charity Mind – expressed concern over the use of the word "promptly." As a result, it says, the proposed new legislation will use the term "as soon as reasonably practical" instead.
6 Comments
"promptly" and "due diligence"..they need clarity. what?
Who are these people?
for example.. the Association of the British Pharmaceutical Industry is a pretty impressive title.
Are they dumb or just evil?
They have some nerve.
I find this laughable ..
They need to clarify basic words like "promptly" and "diligence" ..
Don't they have dictionaries ? ..
"The Medicines For Human Use Regulations 1994 – needed to be changed, following the MHRA’s report earlier this year of its investigation into whether Glaxo failed to inform it in a timely manner about info which it had on the safety of its Paxil antidepressant, knowna as Seroxat in the UK, when used in patients aged under 18."
Because GSK failed to report "promptly" the dangers of Seroxat, many teenagers , young adults and "adults" have been harmed, and some were driven to suicide from Seroxat's (Paxil) horrifying side effects...
It was a lack of "due diligence" on the part of the regulators, the MHRA which allowed this to happen ..
Maybe they should have defined the terms before they licensed the drug? ..
Or maybe Seroxat shouldn't have been licensed at all?..
Henry,
Although I have a reluctance to engage you given your lack of lucidity on this issue, here's what the dictionary says regarding "promptly": "carried out or performed without delay." Let me see, is that one day, one week, one month, one year, or what? Promptly isn't precise and corporations need precise guidance. As for "due diligence", it can be defined as "a term used for a number of concepts involving either the performance of an investigation of a business or person, or the performance of an act with a certain standard of care." So what is that standard? Should every company have their own definition? What information is enough? What is too much? What is meaningful and what is not? Again, these companies are simply asking for more precision.
Atlex
Alex,
I understand what you are saying. However I think the words 'due diligence' and 'promptly' cannot be regulated. qualified professionals working in the pharmaceutical industry should have the good judgement to report and not hide safety data from the public. They are paid enough and apparently have access to all the leading experts in medicine so if they can't make the decision, it is a case of not wanting to make the decision. Of course currently these regulations are not enforced hence the reason for the "lack of understanding" on the pharmaceutical industry's side. once they start locking people up for pharma crimes, they i bet you they will very quickly understand the meanings of due diligence and promptly. Ony a matter of time I hope.
Atlex "Again, these companies are simply asking for more precision."
Do you think we are that stupid Atlex to believe that pharmaceutical companies need to know precisely when they should warn about dangers of their drugs?..
Do they need others to give them lessons on moral codes? ..
Yes, Truthman30, I believe you are!!!!!
It's not about morals or ethics; it's about timing. Shorter timeframes will end up producing less rigorous analyses and more mistakes. Longer timeframes will allow more rigorous analyses and fewer mistakes. Which serves the public more? Let the government decide what the balance should be and the pharma industry will comply.