Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Saturday, November 5, 2011

My brother was told that his FDA MedWatch #5009052 file could not be located.

FOIA Freedom of information Act  answers may include lies.

POGO Project On Government Oversight

Nov 04, 2011

Did Your FOIA Request Really Not Exist--Or is That Just What the DOJ Told You?

By DANA LIEBELSON
The Department of Justice (DOJ) came to its senses on Thursday and scrapped a controversial proposal that would model the Freedom of Information Act (FOIA) on the first rule of Fight Club. Then it backpedaled by saying it has actually been misleading FOIA requesters about the existence of certain documents for the last nearly 25 years--the proposed rule would have just put the practice into its regulations.
The nixed rule revision, which was originally proposed by the DOJ in March 2011, would have empowered agencies under DOJ—like the FBI and Drug Enforcement Administration—to tell FOIA requesters that some excluded records don’t exist—even when the record do, but are excludable under FOIA (like in the case of certain sensitive law enforcement and national security files.)
Unsurprisingly, this sparked backlash from a number of good government groups, several of whom said that the proposal was tantamount to authorizing the government to lie to U.S. citizens. At the request of POGO and allies, the DOJ reopened the comment period on the propose rule. 
Senators from both sides of the aisle also objected. In a strongly worded letter to Attorney General Eric Holder, Senator Charles Grassley (R-IA) said that the proposal stood “in stark contrast to both the President’s and your prior statements about FOIA, transparency and open government.”
In response to the media uproar that ensued, the DOJ dropped the proposal and issued a letter of response to Sen. Grassley—and that’s where things start to get interesting.
Since the 1970s, the DOJ has been allowed to issue the judicially-recognized “Glomar response” to FOIA requesters, which says that the DOJ can neither “confirm nor deny” the existence of a document in the interest of national security, and with an explanation. This rule came about in 1976, when the American mogul and press magnet, Howard Hughes built a ship, The Glomar Explorer, that was used by the CIA to search for a sunken Soviet submarine. When a hungry journalist caught whiff of the story and made a FOIA request, the CIA told her they could neither “confirm nor deny” the existence of the records—and the response was upheld in court.
But in the letter the DOJ sent to Sen. Grassley, Assistant Attorney General Ronald Weich pointed out the DOJ also has been following another policy since 1987, based on guidance issued by Attorney General Edwin Meese. This memo—which  was certainly not well known—says the same thing as the dropped proposed rule: “A requester can properly be advised…that ‘there exist no records responsive to your FOIA request.’”
Weich denied that this was equivalent to lying, adding that "When a citizen makes a request pursuant to the FOIA, either implicit or explicit in the request is that it seeks records that are subject to the FOIA…where the only records that exist are not subject to the FOIA, the statement that 'there exist no records responsive to your FOIA request' is wholly accurate."
The DOJ says they proposed the rule in an effort to make this “past practice more transparent.”
 The reality is that it’s still misleading and undermines the purpose of FOIA. According to a comments submitted sent by POGO’s allies in open government, ACLUCREW, and OpenTheGovernment.org, the practice is also problematic because it thwarts appeals and judicial review for obtaining the documents.
“Few reasonable requesters would litigate FOIA denials where their requests were denied on the grounds that no documents exist, because as far as they would know there would be nothing for a court to compel the government to disclose,” the groups wrote.
Though as it turns out, there may be a slew of new appeals of responses that records do not exist—as requesters from the past quarter century become aware that they may in fact exist.
Some groups have suggested that instead, DOJ simply acknowledge a FOIA request, but say the documents are not subject to disclosure requirements.
Angela Canterbury, POGO’s director of public policy, said “While it’s promising that the DOJ finally agreed to throw out this absurd proposed rule, it is disturbing to learn that they have had a practice of lying to requesters for nearly 25 years. Until that policy changes, there is more for DOJ to do to restore the integrity of FOIA and the administration.”
However, Canterbury is optimistic that the DOJ can find a way to be factual, but also protect national security and law enforcement investigations.
Senator Patrick Leahy (D-VT) offered this statement:
For five decades, the Freedom of Information Act has given life to the American value that in an open society, it is essential to carefully balance the public’s right to know and government’s need to keep some information secret.  The Justice Department’s decision to withdraw this proposal acknowledges and honors that careful balance, and will help ensure that the American people have confidence in the process for seeking information from their government.
 Dana Liebelson is POGO's Beth Daley Impact Fellow.

No comments:

Post a Comment