Pharmaceutical regulatory regime should be overhauled, say MPs

MPs have called for the “lax” pharmaceutical
regulatory regime to be overhauled, saying it has let the interests
of the industry override public safety, writes Mithran
Samuel and Rich Heap.

In a report today, the health select committee says the adverse
reactions caused by a number of drugs, such as the antidepressant
Seroxat, have revealed fundamental flaws in the regulatory
regime.

It says: “An effective regulatory regime to ensure the
industry works in the public interest is essential. Unfortunately
the present regulatory system is failing to provide
this.”

It calls for a wholesale review of the Medicines and Healthcare
products Regulatory Agency, saying it has grown too close to
industry and inadequately scrutinised clinical trials for Seroxat
and other drugs.

It also calls for sponsorship of the industry to be transferred
from the Department of Health to the Department of Trade and
Industry, saying the DoH had let companies’ interests
override its responsibilities towards patients.

The report says the regulatory climate has allowed firms to
suppress clinical trial results and aggressively promote drugs to
prescribers, with GPs in particular overly influenced by the
industry.

It calls for all clinical trial results to be put on an
independent register before companies are given a licence to market
drugs and greater controls on promotional materials.

The report also recommends much tougher restrictions on what GPs
can prescribe and says doctors should declare any significant gifts
they receive from the industry, with a register kept by
professional bodies.

The report is available from www.parliament.uk