{"id":69383,"date":"2016-12-06T14:01:15","date_gmt":"2016-12-06T19:01:15","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=69383"},"modified":"2016-12-07T08:53:52","modified_gmt":"2016-12-07T13:53:52","slug":"is-there-no-bottom","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2016\/12\/06\/is-there-no-bottom\/","title":{"rendered":"is there no bottom?…"},"content":{"rendered":"\n
Just when you think you’ve found the bottom of a rotten barrel, you poke through and there’s even more corruption below. Read these [because you can’t not read them]… <\/div>\n
\n
New Report Exposes “Patient Advocacy” Groups as a Big Pharma Scam<\/a><\/div>\n
The Intercept<\/font><\/strong><\/div>\n
by David Dayen<\/div>\n
December 1, 2016<\/div>\n<\/blockquote>\n
\n
DRUG MONEY: PART I<\/font><\/strong><\/div>\n
FDA Depends on Industry Funding; Money Comes with “Strings Attached”<\/a><\/div>\n
POGO<\/font><\/strong><\/div>\n
by David Hilzenrath<\/div>\n
December 1, 2016<\/div>\n<\/blockquote>\n
\n
DRUG MONEY: PART II<\/font><\/strong><\/div>\n
In FDA Meetings, "Voice" of the Patient Often Funded by Drug Companies<\/a><\/div>\n
POGO<\/font><\/strong><\/div>\n
by David Hilzenrath<\/div>\n
December 1, 2016<\/div>\n<\/blockquote>\n

<\/p>\n\n\n\n
POGO <\/font><\/strong>Recommendations<\/font><\/strong><\/td>\n<\/tr>\n
\n
End Reliance on User Fees<\/font><\/strong>. One way to enhance the FDA’s independence and help prevent the problems identified in this report would be to end the FDA’s reliance on user fees. These are direct payments by manufacturers for certain services provided to them by the FDA. In return, the manufacturers count on special consideration, including faster approvals of drugs. Often “faster” means “less careful” or “less independent.” Congress should not reauthorize the Prescription Drug User Fee Act (PDUFA). Instead, it should use federal appropriations to fund all of the FDA’s work on prescription drugs.<\/div>\n

Eliminate Requirement for FDA to Negotiate User Fees with Regulated Industry.<\/font><\/strong> A short term solution and a more immediate fix to the problems described in this report would be to eliminate the legislative requirement that the FDA negotiate with “the regulated industry” in advance of user fee reauthorization.<\/p>\n

Increase Transparency of Negotiation and Consultation Meetings<\/font><\/strong>. In the absence of either of the previous suggested changes, Congress should require much more transparency in the user fee reauthorization process. It should open to the public the FDA’s negotiating sessions with industry and its consultation meetings with other stakeholders, including patient and consumer groups. Congress should also require online posting of live webcasts, permanent video recordings, and transcripts of those meetings. Consumer groups that do not receive funding from the pharmaceutical or biotech industries should be included in these meetings. Transparency would allow the public and Congress to better oversee the agreements the FDA negotiates with the drug industry over the agency’s funding and its approach to reviewing drugs. It would help the public and Congress determine whether additional reforms are needed to protect public health and safety.<\/p>\n

Require Conflict of Interest Disclosure for Stakeholders.<\/font><\/strong> POGO’s investigation found that the vast majority of the patient advocacy groups that the FDA consulted in the latest round of user fee meetings received funding from the pharmaceutical industry. Congress should require that all stakeholders who participate in meetings with the FDA over user fee renewal disclose all potential personal and financial conflicts of interest. Those disclosures should be posted online when the meetings take place. The disclosures should include, but not be limited to, industry funding of stakeholder groups, industry representation on the boards and staffs of those groups, and board members who serve as employees or contractors to companies in FDA-regulated businesses—e.g., makers of medical devices and contract research organizations, which manage clinical trials for drug companies.<\/div>\n<\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Just when you think you’ve found the bottom of a rotten barrel, you poke through and there’s even more corruption below. Read these [because you can’t not read them]… New Report Exposes “Patient Advocacy” Groups as a Big Pharma Scam The Intercept by David Dayen December 1, 2016 DRUG MONEY: PART I FDA Depends on […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-69383","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/69383","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=69383"}],"version-history":[{"count":7,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/69383\/revisions"}],"predecessor-version":[{"id":69399,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/69383\/revisions\/69399"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=69383"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=69383"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=69383"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}