It's All Change at the Top for EMA

The sudden resignation of Eric Abadie, MD, as Chair of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on April 5 has sent shockwaves through the regulatory world.

New role: Agnès Saint Raymond, MD, is now a member of the United Nations Commission on Life-Saving Commodities for Women and Children.

Abadie's departure came after the termination of his contract as Scientific Advisor to the Director General of the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), the French medicines regulatory authority. An AFFSAPS statement confirmed that he will leave his post there at the end of his contract. The chairmanship of the CHMP is an unpaid position, so he was forced to give up that role when he lost the AFSSAPS work. The EMA declined a request to provide payment for the role, according to the French agency.

AFSSAPS is under close scrutiny for allowing the sale of diabetes drug Mediator (benfluorex) long after it had been pulled from the market elsewhere on safety grounds, according to Reuters. Public concern about the agency has been further increased by the scandal over breast implants manufactured by French company Poly Implant Prothese (PIP). The agency's offices reportedly were raided in February as part of an investigation.

Abadie held the CHMP post since 2007, and has also been a member of the EMA's Committee for Orphan Medicinal Products and chair of its Pharmacogenetics Working Party since 2001. Tomas Salmonson, the CHMP Vice-Chair, will lead the committee in the meantime to ensure continuity while the agency organizes elections for a new chair. Salmonson, who is employed by Sweden's Medical Products Agency, has been a member of the CHMP since 2004. He is also a member of the EMA's Working Party on Pharmacokinetics.

In other news at the EMA during April, Agnès Saint Raymond, MD, the Head of Human Medicines Special Areas, became a member of the United Nations Commission on Life-Saving Commodities for Women and Children. This follows her recent work with the World Health Organization on the international network on pediatric medicines, and her responsibilities on pediatric medicines at the European Union level.

The commission was launched by the United Nations Children's Fund and the United Nations Population Fund, to improve access to essential but overlooked medicines and health supplies. Saint Raymond will continue in her role at the EMA.

More than five million children under the age of five die every year of potentially curable diseases, such as pneumonia, diarrhea, neonatal sepsis, and malaria. Increasing coverage of proven interventions, such as antibiotics for pneumonia, and oral rehydration solution and zinc for diarrhea, can reduce childhood deaths from these two most common illnesses by more than 70%, noted a statement from the EMA. Also, obstetric bleeding, the leading cause of maternal death around the world, results in an estimated 127,000 deaths annually.

The commission will work toward increasing the availability, affordability, accessibility, and use of medicines that can reduce the main causes of child and maternal death. It will identify opportunities to increase the production and supply of commodities for women's and children's health. Also, it will propose strategies to support countries in increasing access to overlooked commodities through private- and public-sector interventions, and will recommend strategies to raise awareness of and demand for these lifesaving products among healthcare providers and end-users.

This commission is expected to work on these objectives until the end of May 2012. It is part of the Every Woman Every Child movement, which aims to save the lives of 16 million of the most vulnerable women and children worldwide by 2015.

Also, EMA has now published its reflection paper on the assurance of ethical and GCP standards in the conduct of clinical trials included in marketing authorization applications submitted in the European Union. The initiative is part of EMA's strategy to address the challenges arising from the increasing globalization of clinical research.

—Philip Ward