Life Science Compliance Update

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July 17, 2014

EFPIA Disapproves of French Off-Label Initiative

On July 8, 2014, the French National Assembly voted a draft law proposal that would potentially allow healthcare professionals to prescribe off-label drugs, even if there is an approved drug available for treatment. The draft law specifically references Avastin, a Roche cancer drug, as an alternative eye treatment for wet age-related macular degeneration, an indication for which the drug is not approved and for which two authorized alternatives exist.

EFPIA, the European Federation of Pharmaceutical Industries and Associations, harshly criticized the proposal. Richard Bergström, EFPIA Director General, said: "A worrying trend is growing across Europe with governments bypassing important health safeguards and making public health decisions based purely on short-term economic considerations. This move is a material breach of the regulatory framework created to preserve the highest standard of patient safety in Europe."

"This is a serious public health issue which the European Commission must address urgently before it becomes more widespread," stated Bergström. "EU Member States should not be creating secondary, national marketing [authorizations] for reasons that undermine the EU regulatory framework and could potentially put patients at risk, and deliver only short-term economic gains." 

Bergström concluded: "If public authorities continue to promote off-label use of other, less costly, medicines that have not undergone stringent safety and efficacy assessments, pharmaceutical companies will be discouraged from undergoing the costly and time-consuming [authorization] process for new indications."  

Macular degeneration drugs such as Lucentis can cost between $1,800 and $2,000 per dose. Avastin is much cheaper. The high cost of Lucentis is one of the reasons ophthalmologists were targeted by the press when the Centers for Medicare and Medicaid Services (CMS) released the Medicare payment database earlier this year.

According to PMLive, the active ingredients in both medicines were developed by Roche subsidiary Genentech. Roche holds US rights to Lucentis, while Novartis holds the European license. Both Roche and Novartis have argued that Avastin was not developed for macular degeneration. It was "manufactured to a different production standard, with higher permissible levels of particulate matter, which means it is not suitable for administration into the eye." The companies argue that using Avastin for treatment puts cost above patient need.

PMLive reports that Italy too supports doctors prescribing Avastin as a cheaper alternative to Lucentis. Furthermore, earlier this year Italy's Ministry of Health said it was seeking €1.2bn in damages from Roche and Novartis for colluding to prevent doctors using Avastin to treat age-related macular degeneration. An earlier probe by Italy alleged that the two companies joined forces to block doctors from buying Avastin for use in treating eye diseases.

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