Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Product Liability Law & StrategyKickerFeaturesSectionsNewsLJN Newsletters

Vioxx and the FDA Advisory Committees: Yesterday, Today, and the Search for Tomorrow

By Edward John Allera

Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's (“FDA's”) failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (“NAIDs”). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, ie, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.

For marketed drug products, the FDA has traditionally acted unilaterally when the risk/benefit calculation for drug approval has been undermined. Today, as the agency's credibility in protecting the public is coming under repeated attack, the advisory committee meeting is providing a variant approach that is another step in the growing importance of advisory committees at the FDA. The advisory committee process increases the transparency of the scientific debate, and the openness demystifies the process. Passions are tempered. The process forces a dialogue on the known facts, and it exposes the voids of data. Transparency stabilizes the process. Nevertheless, the advisory committee meeting remains only one element in the decision-making process. Because the FDA remains legally responsible, it controls that process, including the timing of the meetings, the preparation of briefing documents, and the ultimate decision.

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
The Article 8 Opt In Image

The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.

Beach Boys Songs Written Decades Ago Triggered Current Quarrel With Lawyers Image

There's current litigation in the ongoing Beach Boys litigation saga. A lawsuit filed in 2019 against Nevada residents Mike Love and his wife Jacquelyne in the U.S. District Court for the District of Nevada that alleges inaccurate payment by the Loves under the retainer agreement and seeks $84.5 million in damages.

Major Differences In UK, U.S. Copyright Laws Image

This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.

Strategy vs. Tactics: Two Sides of a Difficult Coin Image

With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.

When Is a Repair Structural or Nonstructural Under a Commercial Lease? Image

A common question that commercial landlords and tenants face is which of them is responsible for a repair to the subject premises. These disputes often center on whether the repair is "structural" or "nonstructural."