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Report Faults FDAs Safety Regulations

by Paige Boldt on 03/03/2013

A new report by the Office of Inspector General at the Department Of Health And Human Services has some very disturbing questions about the effectiveness of the Food And Drug Administration's drug safety regulations.  The report specifically focuses on the drug safety regulations that are commonly known as Risk Evaluation and Mitigation Strategies, or REMS.

The strategies have been in place for years now, and the Food and Drug Administration uses these as part of its condition for the approval of certain drugs.  These strategies are especially used in those cases where the agency is concerned that the drug may have potentially serious side effects.

Initially, when the agency first adopted these REMS, these were meant to be voluntary agreements between the agency and the drug companies.  However, in 2007, the Congress authorized that these rules become a mandatory part of drug approvals.  These REMS evolved from voluntary to strictly enforceable rules.  The Food and Drug Administration was now under pressure to require that companies comply with the restrictions imposed on certain drugs.

However, now the Office of Inspector General's report claims that many of these regulations are ineffective.  On paper, the drug companies should be putting pressure on doctors to impose some restrictions on prescribing practices.  For instance, if a pregnant woman could be at danger if she takes a particular drug, then companies must require that doctors recommend a pregnancy test before prescribing the drug.  However, for the system to work effectively, there has to be some authority involved, and that seems to be sorely lacking to Texas product liability lawyers

As a result, the companies have no control over what doctors are doing, and even if they're able to bear upon doctors to impose these limitations on prescriptions, they are unable to monitor what is happening on the ground.

The report recommends that the Food and Drug Administration be given greater authority, so that it can make these regulations strongly enforceable.

Tags: Pharmaceutical Mass Torts, Product Liability, FDA

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