Tools to Access Federal Documents or Petition the Government

TELL THE FEDS WHAT'S UP!

Freedom of Information Act
The Freedom of Information Act (FOIA) requires federal agencies to make available records requested by individuals. Public Citizen is a great resource for information regarding the use of FOIA requests and examples of FOIA requests for health-related legal cases.

Orange Book
The "Orange Book" (technically, "Approved Drug Products with Therapeutic Equivalence Evaluations"), is maintained and published by the Food & Drug Administration. The O.B. contains information on formulations, dosages, names, and manufacturers of all FDA-approved drugs. It also contains patent information which, since the Hatch-Waxman Act was passed in 1984, is used to facilitate and regulate generic entry into the marketplace.

Petitioning FDA
Anyone can request a change in FDA policy. The guidelines for such a petition can be found at the link above. Public Citizen has used this process to petition the introduction of a potentially dangerous 3rd generation contraceptive and to petition for the removal of Crestor from the market.

Petitioning Center for Medicare and Medicaid Studies
Public Citizen also used a similar petition to request that CMS deny reimbursement of the Vagus Nerve Stimulation device, claiming it was neither 'safe and effective' nor 'reasonable and necessary. Private insurance companies usually follow the reimbursement limits of Medicare and Medicaid, so this action prevented the device from becoming widely available.

Patent Challenges
US patent law allows you to challenge patents that have already been awarded (called 'post-grant' opposition), while many other countries also allow challenges prior to award of a patent (called 'pre-grant' opposition). In the US, the Public Patent Foundation has had much success challenging patents, including key patents of Pfizer's Lipitor and the WARF stem cell patents.

In India, the Lawyer's Collective has used pre-grant opposition to prevent Novartis from obtaining an evergreen patent on its drug Gleevac, a treatment for leukemia that sells 8-12 times cheaper as a generic, unpatented drug. The Lawyer's Collective also used pre-grant opposition to challenge GlaxoSmithKline's patenting of Combivir, an important fixed dose combination therapy to treat AIDS. GSK withdrew its patent application.

Securities and Exchange Commission
Companies that are publicly traded in the US are required certain information quarterly and annually. This information can be found on the SEC website and give a glimpse of the cash flows of the companies and important events going on within the country, sometimes even revenues of specific drugs.

To use:

1. Go to www.sec.gov
2. Under the heading "Filings and Forms', click on 'Search for Company Filings'
3. Click on 'Companies & Other Filers'
4. Enter the name of company. On the next page, select the company that matches.
5. Once you have selected the companies profile, enter the name of the form type you desire in the top right.
   
   Main form types of interest:
   10-K (similar to the annual report)
   10-Q (quarterly version of the 10-K)
   8-K (another annual financial document)
   
   For descriptions of form types, go to the www.sec.gov, select 'Descriptions of SEC Filings' under "Filings and Forms' heading