FDA AND DECLARATION OF HELSINKI

FDA regulations with Declaration of Helsink

Should FDA be permitted to have regulations that are not consistent with Declaration of Helsink

Abstract

After years of a power struggle between the American law makers and the World Medical Association (WMA), in 2008 the US Food and Drug Administration (FDA) took the drastic step of removing references to the Declaration of Helsinki from their documents. In April 2008, the FDA published a regulatory change ending the need for clinical trials conducted outside of the US to comply with the Declaration of Helsinki, for them to accept the data from those trials. The FDA preferred the 1989 version and publicly criticized the Declaration. Indirectly, they gained support from the EU regulators, who in their 2001 Clinical Trial Directive (2001/20/EC)  AND in their 2005 GCP Directive (2005/28/EC) refer to the 1996 version of the Declaration of Helsinki, blatantly ignoring the 2000 version and the 2002/2004 notes of clarification.

Thesis Statement

In this paper we are going to analyze that the FDA should not be permitted to have regulations that are not consistent with Declaration of Helsink.

Generalized obstacles

The Declaration of Geneva of the World health Association binds the physician with the phrases, the health of my patient will be my first consideration, and the International cipher of health Ethics affirms that, a doctor will act only in the patient's interest when supplying medical care which might have the effect of weakening the personal and mental status of the patient (Goodyear & Sprumont, 2009).

When the WMA published the fourth revision of the Declaration (1996), the FDA chose the side of the pharmaceutical industry, and fought the addition to the 1996 Declaration which intended to limit the use of placebos in clinical research where proven interventions had become established. 

In the Declaration of Helsinki 2000, the WMA states that investigational products "be tested against those of the best current prophylactic, diagnostic, and therapeutic methods." They continue to say that "this does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists."

The FDA preferred the 1989 version and publicly criticized the Declaration. Indirectly, they gained support from the EU regulators, who in their 2001 Clinical Trial Directive (2001/20/EC)  AND in their 2005 GCP Directive (2005/28/EC) refer to the 1996 version of the Declaration of Helsinki, blatantly ignoring the 2000 version and the 2002/2004 notes of clarification.

In 2006 the FDA pre-announced their intention to remove all references to the Declaration of Helsinki from their regulations. The WMA published their sixth (2008) revision on October 18, 2008, not budging to the pressure of the FDA, who published the Final Rule in April 2008 . The Final Rule became effective October 27, 2008:

"The final direct restores the obligation that [non-IND foreign clinical investigations] be undertook in agreement with ethical values asserted in the affirmation of Helsinki (affirmation) issued by the World Medical Association (WMA), expressly the 1989 version (1989 Declaration), with a obligation that the investigations be undertook in agreement with good clinical practice (GCP), encompassing reconsider and acceptance ...