EFPIA: French Legislation Undermines EU Regulatory Framework by Endorsing Off-label Use of Medicines for Economic Reasons - Applied Clinical Trials

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EFPIA: French Legislation Undermines EU Regulatory Framework by Endorsing Off-label Use of Medicines for Economic Reasons

Source: Company News Release

EFPIA, the European Federation of Pharmaceutical Industries and Associations, today criticized the intent of the French government to broadly enlarge the use of-off label drugs for economic reasons, even if there is an approved drug available.

Yesterday (July 8) the French National Assembly voted the draft law proposal, which would potentially allow doctors to use off-label drugs even if there is an alternative drug approved. This draft law has still to be reviewed by the French Senate and a review by the French Constitutional Court is also possible.

The draft law specifically references a Roche cancer drug (Avastin) as an alternative eye treatment for wet age-related macular degeneration (AMD), an indication for which the drug is not approved and for which two authorized alternatives exist.

Speaking about this development 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.”

Bergström added: “This is a serious public health issue which the European Commission must address urgently before it becomes more widespread. 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 authorisation process for new indications.”

EFPIA calls on the European Commission to ensure Member States adhere to the European regulatory framework and that financial considerations do not take precedence over the safety of patients.

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