James N. Czaban (FDA Practice Group, Wiley Rein LLP) discusses trending topics of the FDA in regard to drug safety.  A perception exists that the FDA does far more in terms of actual product testing and oversight than it is actually authorized to do, which can result in overconfidence in the safety of the nation’s drug and food supplies.  Misguided outrage is often directed at the FDA, therefore, when a high-profile food or drug safety crisis arises.  Others, however, perceive that the Agency has been too aggressive in regulating industry, especially with regard to the lengthy  drug approval process, advertising and promotional oversight, and in restricting access to investigational new drugs and dietary supplements.  Under President Obama, therefore, the new FDA leadership has placed very visible emphasis on the heightened enforcement and compliance activity of regulated industries.

An important Supreme Court decision in 2009 was Wyeth v. Levine.  In that case, the question considered by the Court was whether FDA labeling requirements preempted decisions by state courts regarding adequate labeling.  The Supreme Court held that there was no preemption.  This puts drug makers in an untenable position of having to guess what a jury might decide is required in a drug label, while at the same time being restricted by FDA in what changes they can make to the label.

In 2010 continued emphasis on enforcement of drug and food safety by the FDA is anticipated.  In regard to Risk Evaluation and Mitigation Strategies (REMS), which were authorized by the FDA Amendments Act of 2007, it is unknown whether the FDA can achieve a REMS policy that strikes an appropriate balance between enhanced safety and prompt patient access to new therapeutics.   In addition, many issues are outstanding regarding the development of guidelines for follow-on biologics; this includes determination of the length of marketing exclusivity to be given to the original innovator versions of such products.   Other FDA trends are discussed.

Source: Metropolitan Corporate Counsel

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