2005N-0285 Current Good Manufacturing Practice Regulation and Investigational New Drugs
FDA Comment Number : EC2
Submitter : Mr. Denish Moorthy Date & Time: 04/05/2006 09:04:26
Organization : Mr. Denish Moorthy
Category : International Public Citizen
Issue Areas/Comments
The regulations governing clinical research, and its validation, in the United States is one of the most stringent in the world. Most countries of the world look to the regulatory process in the United States as a model, as a 'gold standard' to be achieved. I view effects of the direct final rule and its proposed companion rule on 'Current Good Manufacturing Practice Regulation and Investigational New Drugs' from the perspective of the trial participant.

The proposed rule states that the 'regulations' requirement for fully validated manufacturing processes, rotation of the stock for drug product containers, the repackaging and relabeling of drug products, and separate packaging and production areas are generally not concerns', and not relevant to the production of investigational drug products used in Phase 1 clinical trials. However, the intent to ?exempt most investigational 'Phase 1' drugs from complying with the regulatory requirements is a cause for worry.

Phase 1 trials have always been closely monitored and emphasis has been placed on the ethics of many of these trials, because of the many unknown factors that participants in the trials are subject to, and because these trials play a vital role in the development of new medical therapies. Some believe that regulations stifle innovation in these medical therapies.

Most patients enrolled in a phase 1 trial are volunteers and keeping that in mind, it is essential that these trials maintain the highest ethical standards. Even though the Investigational drugs remain subject to the statutory requirement under the existing Investigational New Drug (IND) authority, the information required by the IND authority focuses on the safety and quality of the investigational drug. There is a misconception that the phase 1 trials exist only to determine the right dose and see if the drug is toxic or not, but while these are going on, the evaluation of clinical responses is also an objective. The benefit-versus-risk ratio of Phase 1 trials is favorable, given that they are the first step in finding new treatments for the future.
The regulations, sometimes burdensome, are insurance against any violation of the right of the trials' participants. Be that as it may, granting the exemption to these drugs from complying with all of the regulatory requirements would leave the volunteers without the buffer zone of protection offered by the regulations. I urge you to amend only the relevant regulation requirement, for example, on the repackaging and relabeling of drug products, while retaining the oversight of the Food and Drug Administration in all phases of a clinical trial of a drug

Thank you for your time


Denish Moorthy