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Behind closed doors

Confidential business information is commonly used to hide data about industry products from public view. Researchers, regulators and companies are currently struggling to redefine who needs to know what about commercial products and when they need to know it.

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Figure 1: Large swaths of regulatory documents—sometimes running into tens of pages—can be redacted by regulatory agencies if they feel the information can produce competitive harm.
Figure 2: CBI has increased over the last 20 years, whereas the number of field tests peaked in 2002 and declined.


  1. Rowe, E. Striking a balance: when should trade secret law shield disclosures from the government. Iowa Law Rev. 96, 791–835 (2011).

    Google Scholar 

  2. Code of Federal Regulations. Trade secrets and commercial or financial information which is privileged or confidential. 21 CFR 20.61. (Federal Register, 2002).

  3. Rader, R. Citizen Petition requests biopharmaceutical names and information be disclosed by FDA.

  4. Doshi, P. Transparency interrupted: the curtailment of the European Medicines Agency's policy of access to documents. JAMA Intern. Med. 173, 2009–2011 (2013).

    Article  Google Scholar 

  5. Clinical trials regulation protect human health: choose transparency. (Cochrane, 2013).

  6. European Medicines Agency. Publication and access to clinical trial data. (EMA, 2013).

  7. FDA. Availability of masked and de-identified non-summary safety and efficacy data. Requests for comments. (Federal Register, 2013).

  8. PhRMA & EFPIA. Principles for responsible clinical trial data sharing. (July 18, 2013).

  9. Biotechnology Industry Organization. BIO principles on clinical trial data sharing. (BIO, 2014).

  10. Gymrek, M. et al. Identifying personal genomes by surname inference. Science 339, 321–324 (2013).

    Article  CAS  Google Scholar 

  11. Staton, T. Pfizer settles 2,000-plus Chantix lawsuits, takes $273 million charge. Fierce Pharma (March 4, 2013).

  12. Sipahi, I. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomized controlled trials. Lancet Oncol. 11, 627–636 (2010).

    Article  CAS  Google Scholar 

  13. EMA. Questions and answers on the review of angiotensin II receptor antagonists and the risk of cancer. (EMA, 2011).

  14. Singh, S. et al. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease. J. Am. Med. Assoc. 300, 1439–1450 (2008).

    Article  CAS  Google Scholar 

  15. Butler, D. Tamiflu report comes under fire. Nature 508, 439–440 (2014).

    Article  CAS  Google Scholar 

  16. Research America. National Poll on Clinical Research. (Zogby Analytics, 2013).

  17. Schoen, D.J. et al. Transgene escape monitoring, population genetics, and the law. Bioscience 58, 71–77 (2008).

    Article  Google Scholar 

  18. Committee on the Environmental Impacts Associated with Commercialization of Transgenic Plants. Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation (National Academies Press, 2002).

  19. 5 U.S.C. § 552. FOIA update: The Freedom of Information Act (US Department of Justice, 1996).

  20. US House of Representatives Committee on Oversight and Government Reform. Report card on Federal Government's efforts to track and manage FOIA requests, March 15, 2012 (March 15, 2012).

  21. Baker, G. & Moulton, S. Making the grade. (Center for Effective Government, 2014).

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DeFrancesco, L. Behind closed doors. Nat Biotechnol 32, 528–535 (2014).

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