Risk Evaluation and Mitigation Strategies

In the FDA’s effort to make both its decisions and clinical trial data more transparent to the public, Agency decisions have become more available for public debate.  Sophisticated analyses (increasingly by third parties) of publically available data may present to the FDA a more complex picture of drug safety, as not all posted clinical trials fit standard regulatory paradigms, are sufficiently powered, have similar patient selection criteria,  or collect and analyze similar parameters. Changes made in the interest of public health, therefore, may further complicate regulatory assessment of potential changes to drug status.  For these reasons, among others, drug safety decisions are rarely “black and white.”  To its credit, the “new” FDA seems more open to try a middle path (e.g., the diabetes medicine Avandia will remain on the market under a restricted access program [risk evaluation and mitigation strategy, or REMS]).  Even more unusual, however, was public admission by the FDA of disagreement about Avandia within its own scientific ranks.  Furthermore, 3 top FDA officials co-authored a New England Journal of Medicine article explaining their rationale.  Interpretation of clinical trial data, however, is relatively easy compared to analyses of post-market safety data, where patient populations and indications are even more diverse.  It will be interesting to see how public access to evolving data (e.g., the anticipated FDA post-marketing drug safety (public) website) will affect Agency decisions, the timing of those decisions, and how much influence third-party analyses will have on regulatory outcomes.  The upside to the ensuing debate may be heightened public awareness of the importance of risk management, as all drugs have risk.  With the down-spiral of new drugs both coming to and remaining on the market, an outstanding question is whether the public and subsequently the regulatory environment will become more or less risk adverse as our perception of drug safety and risk management evolves.

Source: The New York Times

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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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The U.S. Food and Drug Administration announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines that a REMS is necessary to ensure that a drug’s benefit outweighs its risks.

An approved REMS that is voluntarily submitted is subject to the same requirements and enforcement as a REMS that was originally submitted as a required proposed REMS.  If an applicant voluntarily submits a proposed REMS, it will not be approved as a REMS until the FDA determines that it is required to ensure that the benefits of the drug outweigh the risks and that it meets the FDAAA criteria.  Proposed REMS that are not approved are not subject to the requirements and enforcement of an approved REMS.  FDA will notify applicants who voluntarily submit a proposed REMS whether the REMS will be required.  If the FDA determines that a REMS is not required, an applicant may undertake voluntary risk management measures that would be performed outside of a REMS.

Differentiation between a REMS and the earlier (i.e., prior to FDAAA) risk minimization action plans (RiskMAPs) is addressed.

Source: FDA Draft Guidance

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