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Download OVERVIEW OF INFORMATION DISCLOSURE FDA WORKSHOP
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Disclosure: And now for the rest of the story … April 5, 2003 Nancy Roach Marti Nelson Cancer Foundation www.CancerActionNOW.org What is disclosure? • • The act or process of revealing or uncovering. Something uncovered; a revelation. www.dictionary.com Why does “disclosure” exist? • Freedom of Information Act • Any person has a right, enforceable in court, of access to Federal agency records except for records protected by nine exemptions • Exemptions intended to protect individuals, corporate entities and national security Two big FOIA exemptions: • Trade secrets – valuable formulas, processes • Confidential business information including sales data, technical designs, customer lists, supplier lists, financial data, research data What does “disclosure” mean in FDA-talk? • FDA: it’s a criminal act to disclose any preapproval information without sponsor permission, including … – Confirmation that a drug is being reviewed – Reasons for being slow, halting a trial or turning down an application – Corrections to faulty information in news articles or press releases – Great results • Applies only to non-public information. Once info is made public anywhere, it’s no longer protected by FDA Why does this matter to us? <yawn> Will this treatment help me more than it harms me? How do you find out? • Prior to approval, all public information about a drug is controlled by the drug’s sponsor, generally a drug or biotech company • Who do you trust? – Popular media: TV and People Magazine “miracle of the month” stories – Company press releases: aimed at investors – News stories: where do they get their info? – Medical journals, medical professionals, other patients FDA regulations: • prohibit disclosure of proprietary information • intended to protect corporate trade secrets and financial information • permit free-flowing FDA communication with drug’s sponsor prior to approval • prohibit FDA communication with the public, including patients and investors, prior to approval End result: • FDA regulations create an impenetrable shield behind which the FDA and drug companies hold their discussions. • FDA cannot correct misinformation or offer their perspective on drugs prior to approval without the drug company’s permission. Resources An FDA official’s presentation on disclosure: • http://www.fda.gov/cber/summaries/binkleytrg.ppt Marti Nelson Cancer Foundation’s efforts on disclosure • http://www.canceractionnow.org/news/ouragenda/disclosure/index.html Code of Federal Regulations • http://www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1 CITE: 21CFR314.430 FDA presentation on ImClone – who knew what, when • http://www.fda.gov/cber/summaries/erbitux101002sj.htm More Questions? Nancy Roach Marti Nelson Cancer Foundation [email protected]
