Early communication of drug safety concerns: a feasibility study on enhancing interaction between the pharmaceutical industry and regulators.
OBJECTIVE
The responsibility for monitoring the safety of marketed medicines is shared between regulatory authorities and the pharmaceutical industry and is underpinned by legal obligations on both sides. Both marketing authorisation holders (MAHs) and regulators initially evaluate and investigate potential safety concerns, and then work together on further review as appropriate. We wanted to test the feasibility of enhanced interaction between MAH and regulator via a regular monthly, two-way communication of potential safety concerns between the MAHs and the Medicines and Healthcare Products Regulatory Agency (MHRA). It was envisaged that such a process would aid prioritisation and planning by both parties, avoid duplication of effort and support a collaborative approach for decision making.


METHODS
Four MAHs took part in the pilot, which was conducted between July 2007 and June 2008. Potential safety concerns were exchanged on a monthly basis. The MAH/MHRA proposed a timeline for evaluation of each potential safety concern. The pilot did not include serious public health issues which are immediately reported to regulatory authorities.


RESULTS
During the pilot, 136 potential safety concerns were exchanged. Thirteen per cent of these resulted in a change to product information for health professionals and patients. There was concurrence between the MAHs and MHRA on timelines proposed for evaluation.


CONCLUSIONS
The pilot proved feasible for the companies involved and indicated potential benefits of a system for avoiding duplication of effort and supporting a collaborative approach to planning and prioritisation of investigation of potential safety concerns between pharmaceutical industry and regulatory authorities.
Swain
Elizabeth
E
GlaxoSmithKline, Global Clinical Safety and Pharmacovigilance, Harlow, Essex, CM19 5AW, UK. elizabeth.j.swain@gsk.com
Morgan
Sarah
S
Brewster
Wendy
W
Kauser
Shahin
S
D003142:Communication; D003657:Decision Making; D004345:Drug Industry / Q000458:organization & administration*; D004335:Drug and Narcotic Control / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005240:Feasibility Studies; D006077:Government Agencies / Q000458:organization & administration; D006801:Humans; D010865:Pilot Projects