The EMA maybe getting too close to the pharmaceutical companies it regulates, thus losing its impartiality. This is the concern raised by the watchdog tasked with investigating administrative irregularities in the European Union, which is launching a strategic enquiry to see if early-stage interactions with firms could influence agency approval decisions.
The European ombudsman will focus on meetings and discussions between drug makers and agency officials before a new medicinal product is submitted for regulatory approval. These pre-submission activities have gained popularity in recent years as the EMA pushes through its efforts to streamline the approval process for important new treatments.
The EMA strives to strike a balance between helping companies prepare their submissions and the need for rigorous and impartial regulatory oversight. The concerns are that such activities may pose some risks, such as that the EMA’s decisions may be influenced by the pre-submission meetings with the drug makers.
The EU Ombudsman has requested that the EMA provide details as to how its pre-submission processes have been managed as well as a statistical overview of such activities between 2012 -2016 and a list of the 10 pharmaceutical companies the EMA held meetings with most frequently during that time.
In an effort to cut through red tape and speed up the approval process for novel drugs to meet with demands from pharmaceutical companies and patient advocacy groups, the EMA has been keen to review and approve applications with much more efficiency than in the past. This has raised concerns by some in Europe however, who fear that the moves to accelerate MAs, including by promoting the “adaptive pathways approach”, will increase risks as drugs may be approved without adequate data from clinical trials to back up their safety and efficacy profiles. One of the biggest critics of the EMA is Germany’s IQWiG, which determes the cost-effectiveness of drugs.
This investigation comes at a time when the EMA is already under scrutiny due to Brexit, and its eventual relocation to another country in the EU once the UK leaves the bloc. The decision of its new location will be announced in October this year.