1. Standing on the Shoulders of Others Marlene Bobka Vice-President FOI Services, Inc. www.foiservices.com

2. FOIA Use to see what US has done Passed in 1966 Given teeth in 1975 Any person, any reason Administered by DOJ

3. Exemptions Nine in all Three common at FDA Personal privacy Confidential commercial info Ongoing legal action

4. Requesting an FDA document Identify self Invoke FOIA Be specific State fees you’re willing to pay All vs. Disclosable

5. The reality 20-day limit largely theoretical Multi-year waits possible Fees can be prohibitive in broad requests Waits vary by document type Things get lost People work at FDA Older documents have quality issues

6. What’s Commonly Requested? Consult the FDA Log FDA Log available under FOIA States who requested what when Especially good for identifying media Tells you where requests are routed Use file numbers for partial blinding

7. Drawbacks of the Log Your requests are published Abbreviations are heavily used No translation key available Limited number of characters allowed No “standing order” permitted Format sometimes changes

8. What’ll You Get? Really ugly documents Redacted with broad swipes of ink Microfiche often cut-up with knife Copier has a molecule of toner left Odd angles not uncommon This is NOT published literature

9. Examples of Requests Establishment Inspection Reports (EIRs) Don’t forget 483s, Correspondence (C/R) Include time frame, co name, location “Most recent” is OK (M/R) DON’T send request to District Districts vary in response time

10. Drug Documents SBOAs not really available any more SBOA Equivalent is pack of reviews Medical Officer’s Review (MOR) Statistical Review (S/R) Labelling Review (L/R) Approval Letter (A/L)

11. Generic Drugs Don’t have all the same sections Bioequivalence Review Bioavailability Review Can often get pre-approval EIR

12. Other Fun Things to Request Reviewer, Investigator CV or SF-171 Meeting Minutes/Transcripts Investigator Diaries Correspondence Training Modules

13. So Where’s the Intelligence? Know your documents EIRs: Look for Overview; Discussion 483s provide a nice list of transgressions In big drug packages, look at A/L first Consider only ordering part of drug package (e.g. MOR) Correspondence points out issues

14. Synthesizing FOIA Info How to do it good (EIR + Clinical from SBOA) Hints on FDA employee likes and dislikes (EIRS, diaries, discussion w/ mgmt) Hints on hiring (correspondence, discussion w/mgmt) Research private company – due diligence through EIRs, Warning Letters, C/R

15. Thank You! Marlene Bobka Mbobka@foiservices.com June, 2006