MHRA failing patients, warns report
pharmafile | April 26, 2005 | News story | Sales and Marketing |
MPs have called for an urgent review of the UK drugs regulator, saying that tougher regulation of the industry is needed.
The Commons Health Select Committee said the MHRA "lacks the discipline and leadership needed to protect patients' health needs" and needed to be more independent from industry and government.
In a wide-ranging report, the MHRA, the pharmaceutical industry and prescribers were heavily criticised for the 'medicalisation' of society – the idea that every problem needs medical treatment.
The Committee's recommendations will be considered by the government but Lord Warner, the health minister, has stressed that the MHRA had a strong reputation.
Its recommendations follow its hearings last year amid growing concerns about the side-effects of drugs, including GlaxoSmithKline's Seroxat, and Merck's Vioxx.
It also comes at a time of growing concern regarding the aggressive marketing of drugs and the influence of the pharmaceutical industry.
The report criticised drug companies for their lack of transparency in the funding of patient groups and said their aggressive promotion of new drugs led to he inappropriate prescription of medicines
It has called for systematic public inquiries whenever a drug is withdrawn on health grounds and for the responsibility of the pharmaceutical industry to be shifted from the Department of Health to the Department of Trade and Industry.
Key recommendations include:
- The wider use of comparative clinical trials, with new drugs compared with existing treatments in the same therapeutic class.
- Earlier consultation between the MHRA and pharmaceutical companies to co-ordinate the nature of clinical trials to be carried out.
- Independent advice on me-too drugs from The National Prescribing Centre.
- The tightening up of ghostwriting guidelines.
- No relaxation of rules regarding DTC Advertising.
- Strengthening of guidelines on disease awareness campaigns.
- Measures to limit the influence of industry on patient groups.
- A heightening of post-marketing drug surveillance in the UK.
- An effective mechanism for tempering the prescribing explosion.
- An independent body maintaining the clinical trials register.
- A review of vergreeningand practices that impede the entry of generic drugs into the market.
