{"id":11661,"date":"2009-03-17T23:41:27","date_gmt":"2009-03-18T03:41:27","guid":{"rendered":"https:\/\/www.policymed.com\/2009\/03\/fda-dont-leak-thisdont-leak-this.html"},"modified":"2009-03-17T23:41:27","modified_gmt":"2009-03-18T03:41:27","slug":"fda-dont-leak-thisdont-leak-this","status":"publish","type":"post","link":"https:\/\/www.policymed.com\/2009\/03\/fda-dont-leak-thisdont-leak-this.html","title":{"rendered":"FDA: Don\u2019t Leak This\u2026\u2026Don\u2019t Leak This"},"content":{"rendered":"<p><font face=\"Arial\" size=\"3\"><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 10pt\"><img loading=\"lazy\" decoding=\"async\" height=\"444\" src=\"http:\/\/a5.vox.com\/6a00cdf7ed27ab094f010980c4625d000b-500pi\" style=\"WIDTH: 141px; HEIGHT: 155px\" width=\"444\" \/><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">Do do do do\u2026.do do do do don\u2019t leak this\u2026 this may sound like a line from the MC Hammer 1990 music hit <a href=\"http:\/\/en.wikipedia.org\/wiki\/U_Can't_Touch_This\"><span style=\"COLOR: purple\">U Can\u2019t Touch This<\/span><\/a>.<span style=\"mso-spacerun: yes\">  <\/span><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">But it is actually the theme of an internal Food and Drug Administration (<a href=\"http:\/\/www.windhover.com\/pdf\/3-13-09_pm_3-52_Torti_Agency-WIde_Email_about_Confidential_Information.pdf\"><span style=\"COLOR: purple\">FDA) memo<\/span><\/a><span style=\"text-decoration: underline;\"><span style=\"COLOR: purple\">randum <\/span><\/span>sent to all employees and you guessed, the memorandum was leaked to the press.<span style=\"mso-spacerun: yes\">  <\/span>(That lasted about mmmm\u2026 20 seconds or just enough time to press the forward button.)<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">The FDA cited several very legitimate reasons for not sharing e-mails and other information with the world including:<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt 38.25pt; TEXT-INDENT: -38.25pt; LINE-HEIGHT: normal; mso-list: l0 level1 lfo1\"><span style=\"FONT-FAMILY: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol\"><span style=\"mso-list: Ignore\">\u00b7<span style=\"FONT: 7pt 'Times New Roman'\">                      <\/span><\/span><\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\">Trade Secrets<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt 38.25pt; TEXT-INDENT: -38.25pt; LINE-HEIGHT: normal; mso-list: l0 level1 lfo1\"><span style=\"FONT-FAMILY: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol\"><span style=\"mso-list: Ignore\">\u00b7<span style=\"FONT: 7pt 'Times New Roman'\">                      <\/span><\/span><\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\">Confidential Commercial Information (CCI)<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt 38.25pt; TEXT-INDENT: -38.25pt; LINE-HEIGHT: normal; mso-list: l0 level1 lfo1\"><span style=\"FONT-FAMILY: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol\"><span style=\"mso-list: Ignore\">\u00b7<span style=\"FONT: 7pt 'Times New Roman'\">                      <\/span><\/span><\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\">Personal Privacy Information<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt 38.25pt; TEXT-INDENT: -38.25pt; LINE-HEIGHT: normal; mso-list: l0 level1 lfo1\"><span style=\"FONT-FAMILY: Symbol; mso-bidi-font-family: Symbol; mso-fareast-font-family: Symbol\"><span style=\"mso-list: Ignore\">\u00b7<span style=\"FONT: 7pt 'Times New Roman'\">                      <\/span><\/span><\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\">Law Enforcement Records and Information<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">But, they added a new one to the list that seems to be a catch all:<span style=\"mso-spacerun: yes\">  <\/span>Privileged Intra-Agency and Inter-agency documents.<span style=\"mso-spacerun: yes\">  <\/span>This covers everything, including e-mails, letters to and from employees within the FDA.<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">I believe there is some reasonableness to all of this, who wants their comments or drafts of a letter shared with the world.<span style=\"mso-spacerun: yes\">  <\/span>We all have said dumb things in e-mails and drafts of documents that, after they have been pointed out, make perfect sense.<span style=\"mso-spacerun: yes\">  <\/span>If you read this column enough you probably understand.<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">There is a need for transparency, but the internal workings are not exactly something that has to become transparent, especially when you are fixing someone\u2019s writing.<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">We saw that just last week, when according to leaked memoranda, the <a href=\"http:\/\/online.wsj.com\/public\/resources\/documents\/WSJ_regenLetter_090303.pdf\"><span style=\"COLOR: purple\">FDA bent over backwards<\/span><\/a> to accommodate RenGen, a small medical device company, despite <a href=\"http:\/\/online.wsj.com\/public\/resources\/documents\/WSJ_510K_090303.pdf\"><span style=\"COLOR: purple\">serious reservations from one of their reviewers<\/span><\/a> (according to <em style=\"mso-bidi-font-style: normal\"><span style=\"text-decoration: underline;\"><span style=\"COLOR: purple\">The <\/span><\/span><a href=\"http:\/\/online.wsj.com\/article\/SB123629954783946701-search.html\"><span style=\"COLOR: purple\">Wall Street Journal<\/span><\/a><\/em>, the FDA was pushed by members of Congress to approve the RenGen device, which now has <a href=\"http:\/\/finance.senate.gov\/press\/Gpress\/2009\/prg030609d.pdf\"><span style=\"COLOR: purple\">Senator Grassley investigating the FDA<\/span><\/a><span style=\"mso-spacerun: yes\">  <\/span>for allowing themselves to be pushed by members of Congress) what a vicious cycle.<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">There is certain information that government agencies should make available to public and is not.<span style=\"mso-spacerun: yes\">  <\/span>For instance, just today, I requested some transcripts from an Institute of Medicine (IOM) open public session which they recorded and got the \u201csorry, but we can\u2019t help you\u201d response.<span style=\"mso-spacerun: yes\">  <\/span>Also, I asked about some grants that the IOM received and was told they do not have any online reporting of their grants and have no plans to publish them.<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">The government is calling for greater transparency from everyone else, perhaps it is time they had some of their own.<o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><em style=\"mso-bidi-font-style: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">The <a href=\"http:\/\/blogs.wsj.com\/health\/2009\/03\/17\/memo-to-fda-staff-dont-leak-this\/\"><span style=\"COLOR: purple\">Wall Street Journal Blog<\/span><\/a><\/span><\/em><span style=\"mso-fareast-font-family: 'Times New Roman'\"> and <a href=\"http:\/\/invivoblog.blogspot.com\/2009\/03\/fda-commish-to-employees-keep-quiet-or.html\"><span style=\"COLOR: purple\">Invivo Blog<\/span><\/a> both have more information on the memorandum, enjoy\u2026.<span style=\"mso-spacerun: yes\">  <\/span><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"BACKGROUND: white; MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal; mso-outline-level: 1\"><strong><span style=\"mso-fareast-font-family: 'Times New Roman'\">Press<\/span><\/strong><span style=\"mso-fareast-font-family: 'Times New Roman'\"><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"BACKGROUND: white; MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal; mso-outline-level: 1\"><em style=\"mso-bidi-font-style: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">The Wall Street Journal Blog<\/span><\/em><span style=\"mso-fareast-font-family: 'Times New Roman'\">: <span style=\"COLOR: black; mso-font-kerning: 18.0pt\"><a href=\"http:\/\/blogs.wsj.com\/health\/2009\/03\/10\/grassley-says-knee-device-maker-was-calling-the-shots-at-fda\/\"><span style=\"COLOR: purple\">Grassley Says Knee Device Maker Was \u2018Calling the Shots\u2019 at FDA<\/span><\/a> <\/span><span style=\"mso-spacerun: yes\"> <\/span><a href=\"http:\/\/blogs.wsj.com\/health\/2009\/03\/17\/memo-to-fda-staff-dont-leak-this\/\"><span style=\"COLOR: purple\">Memo to FDA Staff:<span style=\"mso-spacerun: yes\">  <\/span>Don\u2019t Leak This<\/span><\/a><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><em style=\"mso-bidi-font-style: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">The Wall Street Journal<\/span><\/em><span style=\"mso-fareast-font-family: 'Times New Roman'\">: <a href=\"http:\/\/online.wsj.com\/article\/SB123629954783946701-search.html\"><span style=\"COLOR: purple\">Political Lobbying Drove FDA Process<\/span><\/a><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><span style=\"mso-fareast-font-family: 'Times New Roman'\">InVivo Blog: <a href=\"http:\/\/invivoblog.blogspot.com\/2009\/03\/fda-commish-to-employees-keep-quiet-or.html\"><span style=\"COLOR: purple\">FDA Commissioner to Employees:<span style=\"mso-spacerun: yes\">  <\/span>Keep Quite or Else<\/span><\/a><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"BACKGROUND: white; MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal; mso-margin-top-alt: auto\"><strong style=\"mso-bidi-font-weight: normal\"><span lang=\"EN\" style=\"COLOR: black; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN\">FDA<\/span><\/strong><span style=\"mso-fareast-font-family: 'Times New Roman'\"><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"BACKGROUND: white; MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal; mso-margin-top-alt: auto\"><span lang=\"EN\" style=\"COLOR: black; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN\"><a href=\"http:\/\/www.windhover.com\/pdf\/3-13-09_pm_3-52_Torti_Agency-WIde_Email_about_Confidential_Information.pdf\"><span style=\"COLOR: purple\">Memorandum from Frank Torti, M.D., Acting Commissioner<\/span><\/a> on protecting confidential information (March 13, 2009)<\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\"><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"BACKGROUND: white; MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal; mso-margin-top-alt: auto\"><span lang=\"EN\" style=\"COLOR: black; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN\"><a href=\"http:\/\/online.wsj.com\/public\/resources\/documents\/WSJ_510K_090303.pdf\"><span style=\"COLOR: purple\">Memorandum from FDA Review Team Leader, John S. Goode<\/span><\/a>, detailing why he opposed approving the RenGen device (Aug. 14, 2008 )<\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\"><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"BACKGROUND: white; MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal; mso-margin-top-alt: auto\"><span lang=\"EN\" style=\"COLOR: black; mso-fareast-font-family: 'Times New Roman'; mso-ansi-language: EN\"><a href=\"http:\/\/online.wsj.com\/public\/resources\/documents\/WSJ_regenLetter_090303.pdf\"><span style=\"COLOR: purple\">FDA lawyers' memoranda<\/span><\/a> about language that might "document special treatment" for RenGen (Nov. 3, 2008)<\/span><span style=\"mso-fareast-font-family: 'Times New Roman'\"><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 12pt; LINE-HEIGHT: normal\"><strong style=\"mso-bidi-font-weight: normal\">Senator Grassley:<\/strong><span style=\"mso-spacerun: yes\">  <\/span><a href=\"http:\/\/finance.senate.gov\/press\/Gpress\/2009\/prg030609d.pdf\"><span style=\"COLOR: purple\">Letter to FDA and RenGen<\/span><\/a><span style=\"mso-fareast-font-family: 'Times New Roman'\"><o:p><\/o:p><\/span><\/p>\n<p class=\"MsoNormal\" style=\"MARGIN: 0in 0in 10pt\">\n<p><\/font><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Do do do do\u2026.do do do do don\u2019t leak this\u2026 this may sound like a line from the MC Hammer 1990 music hit U Can\u2019t Touch This.  But it is actually the theme of an internal Food and Drug Administration (FDA) memorandum sent to all employees and you guessed, the memorandum was leaked to the press.  (That […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[1101],"class_list":["post-11661","post","type-post","status-publish","format-standard","hentry","category-fda","tag-new"],"_links":{"self":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/11661","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/comments?post=11661"}],"version-history":[{"count":0,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/posts\/11661\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/media?parent=11661"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/categories?post=11661"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.policymed.com\/wp-json\/wp\/v2\/tags?post=11661"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}