Posted 10/1/07 (By Travis)
SOMA Resolution on FDA approval
This past weekend,
SOMA (Student Osteopathic Medical Organization), representing over 14,000* Medical Students, 15%* of
the total medical students in the United States, passed the following resolution (only the final
'RESOLVED' statement was officially passed, the 'WHEREAS' parts are included here only for
completeness):
Subject: SOMA Resolution on FDA approval
1) WHEREAS, New pharmacological advances have resulted in major healthcare
2)
3) advances and enabled physicians to enhance patient care (4),
4)
5) WHEREAS, This year the FDA has so far approved only 7 NCE (new
6)
7) chemical entities), down 31% from last year (1),
8)
9) WHEREAS, It takes an average of 12-10 years and $400-800 billion to
10)
11) bring a new drug from lab to marketplace, in large part due to legal and
12)
13) current regulatory compliance (2), (3),
14)
15) WHEREAS, Generic drugs take over 20 months for approval,
16)
17) increasing cost and decreasing access (6), (7), (8),
18)
19) WHEREAS, Terminally ill patients are routinely denied opportunity to
20)
21) try new or experimental drugs and therapies (5), (9), (10), (11),
22)
23) therefore be it;
24)
25) RESOLVED, SOMA recommend agencies investigate ways to: 1)
24)
25) Review, reform, and hasten the current regulatory processes regarding
26)
27) the current FDA approval process for NCE (new chemical entities). 2)
28)
29) Review, reform, and hasten the current FDA approval process for
30)
31) generic brands. 3) Review, reform, and ease the FDA rules and
32)
33) regulations for entry of properly consenting terminally ill patients into
34)
35) clinical trials. Specifically, the FDA should not be allowed to prevent a
36)
34) terminally ill, properly consenting, educated, and fully lucid adult, from
35)
36) undergoing experimental treatment(s).
1) http://www.physorg.com/news106639362.html
2) http://www.allp.com/drug_dev.htm
3) http://www.fdareview.org/harm.shtml
4) http://www.telegraph.co.uk/news/main.jhtml
6) http://www.washingtonpost.com/wp-dyn/content/article/2006/02/03/AR2006020302598.html
7) http://www.medscape.com/viewarticle/421495_3
8) http://www.fda.gov/fdac/features/2003/503_drug.html
9)http://www.washingtonpost.com/wp-dyn/content/article/2007/07/05/AR2007070502149.html
10) http://reason.com/news/printer/120763.html
11) http://www.abigail-alliance.org/
This resolution will be passed onto the pertinent committee(s) at the AOA (American Osteopathic Association), which represents 52,000 DOs, 5% of the country's physicians, for their review.