UK government probe finds major failings in drug regulation

These findings have been highlighted in a report carried out by the House of Commons Health Committee. In the report, the committee stated that UK regulatory authority the MHRA has “significant failings”, including a lack of transparency, which has underlined a poor record in recognizing potential drug risks, amongst other things.

The probe also highlighted the potential for conflict between commercial and health interests, and accused the MHRA of being focused mainly on rapidly bringing drugs to market.

The report recommended that the MHRA publishes both materials received from drug companies and assessments sent to advisory bodies as part of its licensing process. It also welcomed plans to include lay members on every MHRA advisory committee, stressing the need for sufficient training to enable these members to contribute effectively to decision making.

In addition, the committee recommended that the MHRA has a more active role in the early stages of drug development, as does the FDA, as well as stepping up its post-marketing surveillance efforts.

Other conclusions drawn include that a public inquiry should be initiated whenever drugs are withdrawn due to health reasons, that drug marketing should be curbed, and that a healthy generics market should be encouraged.