Rethinking and Restructuring the FDA Drug Approval Process in Light of the Vioxx Recall
Dohrman, Amanda J., Journal of Corporation Law
On September 30, 2004, Merck & Co. (Merck) announced that it would immediately withdraw its second most profitable drug, Vioxx, from worldwide markets.1 The company's announcement ignited serious concerns about the Food and Drug Administration's (FDA) pre-market approval procedures for prescription drugs. Although Merck voluntarily chose to withdraw its widely popular and profitable drug without FDA mandate, critics contend that the FDA cannot rely on private drug manufacturers to selfregulate their products. Merck's decision is a mere indicator of the substantial problems that cripple the effectiveness of FDA pharmaceutical regulatory approvals, particularly in regard to the management and use of clinical trials in the research and approval process.2 In light of the Vioxx recall, the FDA must develop a new protocol for approving commercial drugs that properly balances timely prescription drug commercialization with mindful, effective, and commercially reasonable safety standards. The FDA must do so as a collaborative effort with private drug manufacturers so that it can hold them responsible if they fail to disclose vital information to consumers or impede the PDA's drug approval review.
This Note reviews the events that caused Merck to recall Vioxx and uses Vioxx as an example to critically analyze the policies and politics of the FDA drug approval process. After outlining the basic drug approval process, this Note analyzes two significant problems that cripple the FDA drug review system. First, drug manufacturers have too much financial influence on the drug review process and pressure the FDA to approve drugs too quickly. second, current FDA review practices are inadequate because the FDA has failed to implement a national clinical drug trial registry that would inspire transparent drug development and peer review by the scientific community. To minimize these harms, the FDA ought to establish a national clinical trial registry that could be partially funded by fees paid by drug manufacturers. Lastly, this Note recommends that the FDA establish an independent review board funded by the Prescription Drug User Fee Act to regulate the clinical trial registry. This board will ensure that both the FDA and drug manufacturers comply with their responsibilities to disclose all pertinent drug information to consumers, which will make the drug approval process more translucent and effective.
II. BACKGROUND: THE DRAMA OF MERCK, Vioxx, AND THE FDA
A. The Drama of the Vioxx Recall
Merck's decision to withdraw Vioxx (generically named rofecoxib) from worldwide markets in the fall of 2004 was based on clinical trial data indicating that chronic use (18 months) of Vioxx resulted in an increased risk of cardiovascular events such as heart attacks and strokes.3 The recall was the largest and most expensive drug withdrawal in recent history; nearly 20 million Americans used Vioxx for arthritis and similar pain relief and were affected by Merck's decision.4 The withdrawal was significant because Merck had promoted Vioxx as its powerhouse prescription by investing more than $500 million in consumer and professional advertising, including a widely recognizable television ad featuring champion skater Dorothy Hammel effortlessly skating without arthritis pain by using Vioxx.5
Specifically, Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) similar to aspirin and ibuprofen. It is popularly used to treat arthritis because, like all NSAIDs, Vioxx has anti-inflammatory and analgesic properties.6 Vioxx is distinct from other NSAIDs, however, because it mechanistically works as a COX-2 inhibitor. A COX-2 inhibitor specifically blocks the cyclooxygenase-2 (COX-2) enzyme that is known to cause severe gastrointestinal (GI) bleeding, but does not block the cyclooxygenase-1 (COX-1) version of the enzyme that produces desirable anti-inflammatory and analgesic effects.7 Patients who take traditional NSAIDs suffer severe GI side effects, such as GI bleeding and ulcers, because those NSAIDs operate by inhibiting both COX-1 and COX2. …