Policy Intern Cassandra LaRussa researched and wrote this post.
In February, ProPublica reported on an almost $10 million fine imposed on the Red Cross by the Food and Drug Administration. The article highlights several safety violations including the following:
- Red Cross “offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner”
- Red Cross “failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood”
- Red Cross “failed to review records of donors who had bad reactions, such as a sixteen year old girl who lost consciousness and fell to the floor after giving a unit of blood”
Each of these, and many other violations, are outlined in the FDA’s Adverse Determination Letter to the Red Cross that was accessed via the FDA Office of Regulatory Affairs FOIA Electronic Reading Room on the FDA’s website. It is unlikely that ProPublica would have information about the specific violations that led to the monetary penalties without access to this letter.
The Electronic Freedom of Information Act Amendments of 1996 required electronic reading rooms contain documents in the public interest. The FDA sites the following guidelines for deciding which documents will be made available in the reading rooms:
“We are making these records publicly available either (1) proactively at our discretion or
(2) because they are “frequently requested” per the Electronic Freedom of Information Act Amendments of 1996.”
While the FDA determined that the “Adverse Determination Letter to the Red Cross” should be public, either through actual or anticipated requests, there is no legislative or agency requirement that the letter must be available to the public. Additionally, the requirements for making documents public are vague and they don’t guarantee that all documents that are of public interest – like ones similar to the letter to the Red Cross — will be placed in the reading rooms.
According to the 2010 FDA Transparency Initiative Report, documents are proactively posted in the Electronic Reading Room “when a high level of public interest is anticipated.” In addition, the report explains that the “FDA may post in the ORA Electronic Reading Room ‘frequently requested’ inspection reports as defined by the Electronic Freedom of Information Act Amendments of 1996.”
These amendments to FOIA attempt to clarify what documents will be placed in an electronic reading room.
“(D) copies of all records, regardless of form or format, which have been released to any person under paragraph (3) and which, because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records; and
(E) a general index of the records referred to under subparagraph (D)”
“The News Without Transparency” shows you what the news would look like without public access to information. Laws and regulations that force the government to make the data it has publicly available are absolutely vital, along with services that take that raw data and make it easy for reporters to write sentences like the ones we’ve redacted in the piece above. If you have an article you’d like us to put through the redaction machine, please send us an email at firstname.lastname@example.org.