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 At the same time, FDA issued a draft guidance providing recommendations on manufacturing Phase 1 material (to replace the formal, legal cGMP regulation).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 regulating Phase 1 material by means other than cGMP regulation, to rely 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 the information submitted by sponsors in Investigational New Drug (IND) Applications. 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:

• Guidance for Industry: INDs – Approaches to Complying to cGMP during Phase I (read sections I through V)
• 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 Immela

documents up loaded here: http://www.mediafire.com/?06xqic8t0qxv3uu

Essay

The events and comments surrounding this move by FDA to eliminate formal cGMP adherence for Phase I studies lead 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 addressing 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. 

Grading

Grading rubric is in zip file

Post-script

Note that in fall 2008, the FDA did ultimately approve this rule for GMPs in Phase I clinicals. They did make some amendments but it is not too different from what you’ll read for this assignment. You do NOT need to address the fact that this is now approved in your essay.

will provide previous lecture reading materials if needed