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FDA issues risk guidance

New guidance setting out the ways by which companies can improve their drug safety regimes and minimise the risks has been issued by the FDA.

New guidance setting out the ways by which companies can improve their drug safety regimes and minimise the risks has been issued by the US Food and Drug Administration.

The announcement, which comes in the wake of a several high-profile drug-related problems, was expected and arrives as the agency seeks to emphasise its enhanced focus on safety in front of Congressional hearings.

The final guidance takes the form of three documents:

  • Premarketing risk assessment
  • Development and use of risk minimisation action plans
  • Good pharmacovigilance practices and pharmacoepidemiologic assessment

They describe various methods pharma firms can use, such as additional safety testing, monitoring and interventions throughout the entire drug lifecycle. One key area is noted as a ìbroader input from patients, healthcare professionals and the publicî when making recommendations about whether to initiate, revise or end risk minimisation interventions.

The final guidance on premarket risk assessment includes a section on 'special safety considerations', which describes how a risk assessment can be tailored for products intended to be used chronically, or in children.

Postmarketing vigilance should also be heightened for products in general use. The FDA's guidance refers to ìinterpreting signals in terms of riskî and planning to provide information about products with ìunusual safety signalsî.

Paul Seligman, director of the regulatory agency's office of pharmacoepidemiology and statistical science, said the aim of the initiative was ìcloser than earlier discussions and collaboration between the FDA and industry on safety issuesî.

However, it appears unlikely that the guidelines will satisfy all members of Congress who are looking for a more independent drug safety system. Some of the guidelines merely codify practices that are already in place, and one recommends that pharma companies work with the FDA division that reviewed its drug for approval to draw up a risk-minimisation plan.

Meanwhile, new FDA Advisory Committee recommendations around the COX-2 class of painkillers could work to the advantage of Pfizer's Bextra and Celebrex but to the detriment of Merck's Vioxx, according to health research firm NOP World Health.

ìIf Vioxx comes back to market, lingering concerns about cardiovascular risks may limit its potential,î said Keith Loehlein, senior vice president of NOP World Health's market assessment practice. ìTo re-establish the product, Merck will have to ease fears about cardiovascular side effects.î

The advisory committee recommended in February that Celebrex and Bextra could remain on the market and Vioxx could potentially return. However, all three products must now carry a black-box warning about the increased risk of cardiovascular events.

Overall, the committee concluded that while cardiovascular risk was a class effect, variations in the safety profiles of different COX-2s and their dosages meant all drugs in the class had to be considered on a case-by-case basis.

30th September 2008


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