Drug safety: FDA pushes for manufacturers to take greater responsibility

The FDA wants pharmaceutical companies to take responsibility for the safety of their drugs.

The FDA has told the US Senate that drug manufacturers need to take responsibility for their products' safety. According to the regulator, Congress' willingness to increase funding for more inspections is not enough. Instead, the FDA says that it needs more power to punish irresponsible companies.

The FDA has fought back against what it feels are unrealistic demands from Congress on its remit and resources. It is currently not able to cope with the sheer volume of drugs being manufactured abroad, which is being exacerbated by poor IT infrastructure to monitor drug safety.

In the last 10 years, drug manufacturing has taken place abroad, with drugs then imported back into the US. This has left the FDA out of its depth as it struggles to cope with monitoring drug safety throughout the supply chain. With the increase in generic drugs being produced in as many as 15 different facilities worldwide, the FDA is overwhelmed. It has increasingly taken on more responsibility outside of manufacturing inspections, leaving this area inadequately resourced.

The question still remains: would increasing the number of inspections have prevented Baxter's blood thinning agent Heparin (heparin sodium) scandal earlier this year? Republican Senator Enzi believes that increased inspections could not have stopped the contaminated Heparin slipping through the net. Chinese regulators have also refused to take responsibility for the Heparin scandal, stating that it is up to manufacturers to ensure that their products are safe.

In reality, the FDA does need more funding, but still faces the difficult task of monitoring safety on a global scale, Giving the regulator more powers to make manufacturers more accountable may be a much more effective method of ensuring drug safety.

However, the pharmaceutical industry will not welcome more pressure from the FDA in terms of monitoring its manufacturing processes, which will be costly. The industry is already very cost conscious given the current problems that it faces with generic drugs eating into its profits after expiring blockbuster drug patents, as well as weak new product pipelines. However, while the industry may see increased FDA pressure as yet another hurdle, in the long term, taking steps to ensure drug safety may reap its own rewards.

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