UK pharma opposes off-label rule change
pharmafile | June 6, 2011 | News story | Sales and Marketing | off label
Prescribing a drug off-label when a licenced alternative exists increases patient safety risks and threatens the development of new medicines, according to the ABPI.
This was the message contained in the UK industry body’s response to the General Medical Council’s consultation on off-label drug use, an issue which has generated considerable controversy in recent months.
The GMC review has been prompted by a number of high profile cases, which have brought the medical profession into conflict with pharma over off-label prescribing.
A high profile example involves Roche’s Avastin (bevacizumab) being used off-label by ophthalmologists for the eye disease wet AMD, instead of Novartis’ Lucentis (ranibizumab). The drugs are chemically similar, but off-label use of Avastin is much cheaper than Lucentis.
In another case Pharmafocus understands that US pharma company BioMarin threatened to sue UK doctors who prescribed an older, chemically similar – though unlicensed – form of Firdapse, its orphan drug for Lambert Eaton Myasthenic Syndrome (LEMS).
BioMarin deny the acqusation and said it “believes in working with doctors to ensure that patients with rare diseases such as LEMS are treated in the most appropriate and effective way to improve their symptoms”.
The GMC is proposing to allow doctors to prescribe drugs off-label when there is a licensed alternative, as this “does not interfere with their [doctors’] ethical considerations”.
The doctors’ regulator is aiming to make specific changes to its ethical guidelines in an effort to make off-label use clearer for doctors.
But the ABPI said that even if doctors believe it is the right thing to do, off-label prescribing will still put patients at risk, because of a lack of safety data for non-approved uses for drugs.
It said patients should also have a right to know they are being prescribed an off-label drug, contradicting the GMC. The ABPI said allowing this would not be “aligned with the GMC’s wider ethical guidance”.
The pharma industry body also believes that encouraging such a practice will hinder the development of new drugs, and will prove a disincentive for companies to submit new medicines.
Speaking to Pharmafocus the ABPI’s outgoing Director General Richard Barker said he didn’t believe the practice was right for patients.
“We think it is completely wrong to change the prescription from one kind of drug to another in order to simply save money if that puts the patient at risk or offers them less good care,” he said.
“Of course doctors should manage resources well, but I don’t think the patient wants to go into his office and think that this doctor is being driven by saving money when prescribing.
“To switch to a drug that is not even licenced for an indication is definitely a step too far,” he concluded.
Ben Adams
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