A Case Study in Regulation

Background
On January 17, 2006, FDA issued a direct final rule/proposed rule to exempt investigational drugs and biologics for phase 1 human clinical trials from the cGMP regulation. As you know, it is a requirement that all clinical and commercial drugs and biologics, such as vaccines, be made per cGMP regulation. At the same time, FDA issued a draft guidance providing recommendations on manufacturing Phase 1 material (to replace the formal, legal cGMP regulation). FDA was proposing to regulate Phase 1 material by means other than cGMP regulation, by relying on the broad applicability of the Food, Drug, and Cosmetic Act (which states that drugs not made per cGMPs are adulterated, but does not provide specifics) and by the information submitted in Investigational New Drug (IND) Applications by sponsors. FDA stated that they were taking the action “to streamline and promote the drug development process.”
Preparation
Read the following documents to prepare yourself for an essay response on this proposed rule:
FDA Guidance for Industry: INDs – Approaches to Complying to cGMP during Phase I (read sections I through V)
History of GMPs – Power of Storytelling article by Barbara Immel
Barbara Immel comments on Direct Final/Proposed Rule
Optional: Chipping Away the GMPs (Powerpoint slides as a pdf) by Barbara Immel
Essay
The events and comments surrounding the FDA proposal to eliminate formal cGMP adherence for Phase I studies led the Agency to withdraw the rule on May 2, 2006 due to the significant adverse comments they received by individuals and groups, such as the Immel Group. This result is important because it is a timely reminder of the complexity involved in changing regulation and also the impact that the public can have on shaping how the FDA regulates this industry.
Write a three-page essay (12-pt font, double-spaced) based on your experience in this course and the preparatory readings above that addresses the following prompt:
Reflect on the how history has shaped the GMPs and the purpose of Phase I clinical trials. Identify the most compelling points in ensuring that GMPs remain in effect for Phase I trials or, alternatively, outline how Phase I trials could be expedited by limiting applicability of GMPs. (Don’t forget to cite your sources within your paper and in a works cited page.)