Transcript OVERVIEW OF INFORMATION DISCLOSURE FDA WORKSHOP

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]