New FDA Requirements for Post-Marketing Studies and Clinical Trials Using Patents as a Strategy for Recovering Costs Prior to Generic Entry

Terry G. Mahn, Fish & Richardson
Bloomberg Law Reports: Health Law
November 2009

In July 2009, the FDA released guidance implementing 505(o) of the Federal Food, Drug, and Cosmetic Act, a powerful new law authorizing the FDA to require post-marketing studies and clinical trials for drug and biological products found to raise safety concerns. For pioneers, it means potentially significant new costs of doing business over which they may have little control. To recover these high costs prior to generic launch, pioneers may be well advised to look into a patent strategy.

New Post-Marketing Rules

Prior to 2007, post-marketing studies and clinical trials were something of a rarity, required only for accelerated approvals, deferred pediatric studies or approvals based on animal efficacy studies. Unlike pre-marketing trials, which are strictly regulated by FDA rules, post-approval studies were subject to less rigorous oversight, and information gathered was seldom made public. The Medicare Modernization Act of 2003 gave the FDA greater authority to monitor these trials, but did not expand FDA authority to order them.

In 2007, after several well-publicized drug withdrawals, Congress passed the FDA Administrative Amendments Amendments Act of 2007 (FDAAA), giving the FDA broad powers to require post-marketing studies or clinical trials1 for any drug or biologic for which "new safety information" becomes available. The FDAAA defines "new safety information" to include any information derived from a clinical trial, an adverse event report, a post-approval study or peer-reviewed biomedical literature; data derived from a risk evaluation and mitigation strategy (REMS); or other scientific data deemed relevant by FDA about a "serious risk," or the effectiveness of a REMS. "Serious risks" are defined as those that could result in death, risk of death, hospitalization, incapacity, substantial disruption of normal life functions, or birth defects, or require medical or surgical intervention.

The FDA guidance indicates that NDA applicants will have input on the design and conduct of all studies, however, such input is purely discretionary, as the FDA is given authority to impose post-marketing requirements (PMRs) unilaterally, and can pursue legal action against non-compliant manufacturers for unapproved marketing or misbranding of drugs.