{"id":925,"date":"2004-06-19T10:49:47","date_gmt":"2004-06-19T15:49:47","guid":{"rendered":"https:\/\/rojisan.com\/blog\/2004\/06\/fda-memo-may-show-politics-over-science\/"},"modified":"2004-06-19T10:49:47","modified_gmt":"2004-06-19T15:49:47","slug":"fda-memo-may-show-politics-over-science","status":"publish","type":"post","link":"https:\/\/rojisan.com\/blog\/2004\/06\/fda-memo-may-show-politics-over-science\/","title":{"rendered":"fda memo may show politics over science"},"content":{"rendered":"

from the san francisco chronicle, but originally broken by the washington post (which requires registration, so we avoid it when possible), today we have some more information on the relative merits of science<\/a> in the formulation of bush administration policy. in this case, we’re talking about the health of americans and the fda, as opposed to, for example, the department of defense and a missile shield<\/a>.<\/p>\n

to refresh the story, the fda denied approval<\/a> for over-the-counter access to a morning-after contraceptive in early may. the actual letter is here<\/a> [pdf], and a q&a page is available here<\/a>.<\/p>\n

\n
FDA Issues Not Approvable Letter to Barr Labs; Outlines Pathway for Future Approval<\/a> [fda]<\/div>\n

FDA\u2019s letter to the sponsor notes that the application does not provide adequate data to support use of Plan B by young adolescent women without the intervention of a physician.<\/p><\/blockquote>\n

the new information suggests that this is a new approach to the health issue:<\/p>\n

\n
Experts not behind reversal on Plan B FDA bowed to politics, critics say<\/a> [san francisco chronicle, june 18]<\/div>\n

“The agency has not (previously) distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case,” wrote John Jenkins, director of the FDA’s Office of New Drugs, which oversees all drug reviews for the agency.<\/p><\/blockquote>\n

yet-another-leaked-memo and yet-another-agenda-over-science-policy-criticism. is the bush administration in for death by a thousand pricks?<\/p>\n","protected":false},"excerpt":{"rendered":"

from the san francisco chronicle, but originally broken by the washington post (which requires registration, so we avoid it when possible), today we have some more information on the relative merits of science in the formulation of bush administration policy. in this case, we’re talking about the health of americans and the fda, as opposed […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[12],"tags":[],"_links":{"self":[{"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/posts\/925"}],"collection":[{"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/comments?post=925"}],"version-history":[{"count":0,"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/posts\/925\/revisions"}],"wp:attachment":[{"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/media?parent=925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/categories?post=925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rojisan.com\/blog\/wp-json\/wp\/v2\/tags?post=925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}