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Disclosure: And now for the rest of the story …

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?.

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Disclosure: And now for the rest of the story …

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  1. Disclosure: And now for the rest of the story … April 5, 2003 Nancy Roach Marti Nelson Cancer Foundation www.CancerActionNOW.org

  2. What is disclosure? • The act or process of revealing or uncovering. • Something uncovered; a revelation. www.dictionary.com

  3. 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

  4. 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

  5. What does “disclosure” mean in FDA-talk? • FDA: it’s a criminal act to disclose any pre-approvalinformation 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

  6. Why does this matter to us? <yawn>

  7. Will this treatment help me more than it harms me?

  8. 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

  9. 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.

  10. 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

  11. More Questions? Nancy Roach Marti Nelson Cancer Foundation nancyroa@aol.com

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