You are browsing the archive for FDA.

Dissenters’ Digest for July 22–August 4

1:32 pm in Uncategorized by MSPB Watch

ATF Director B. Todd Jones

Dissenters’ Digest takes a look back at news stories covering whistleblowers, watchdogs, and government accountability. Look for it every other Saturday evening at www.dissentersdigest.com.

Is the tide turning on whistleblower rights? There are signs of hope. First, ATF director B. Todd Jones clarified his remarks on what seemed to be a threat to his employees not to blow the whistle outside the chain of command. Now, Jones is reaffirming ATF employees’ rights under the Whistleblower Protection Act.

Second, a psychologist who blew the whistle about child abuse on an Indian reservation and was harassed for it is no longer under duress. Congressional and media pressure has resulted in a full reversal of several adverse actions taken against him by the Indian Health Service.

Not so fast: The Food and Drug Administration is apparently engaging in a classic character assassination campaign against the ringleader of the FDA 9, a group of scientist/whistleblowers who have been targeted for spying and harassment. The New York Times served up what has been received as a biased, personality-focused hit piece, but not before the editorial board criticized the FDA for engaging in spying. In some ways, this ambiguity completely reflects how people feel about whistleblowers. Still, NYTimes, wtf?

Below the Fold:

–Department of Justice HR officials are implicated in a nepotism ring.

–Open government groups, led by the Government Accountability Project, issued rules for prior restraint of whistleblowers’ speech. I have called for the lead lobbyist’s resignation after the end of this congressional session.

–A Senate bill would provide new protections for anti-trust whistleblowers.

–UBS whistleblower Bradley Birkenfeld, who helped the IRS uncover the biggest tax fraud in U.S. history, has been released from prison after 30 months.

Send tips to dissent@dissentersdigest.com.  

Dissenters’ Digest for July 8-21

10:00 am in Uncategorized by MSPB Watch

Dissenters’ Digest takes a look back at news stories covering whistleblowers, watchdogs, and government accountability. Look for it every other Saturday evening at www.dissentersdigest.com.

Chilling Effect: Acting ATF Director B. Todd Jones spoke in an internal video to ATF employees where he appeared to admonish his subordinates not to blow the whistle outside the chain of command, lest they face “consequences.” He did not mention they have the right to do so under numerous laws, including the Whistleblower Protection Act of 1989 and the Lloyd-La Follette Law of 1912, which allows civil servants to communicate with Congress without prior restraint. Sen. Chuck Grassley and Rep. Darrell Issa are investigating.

If Nixon had Keylogging Software: The New York Times reported last week that the Food and Drug Administration’s suspected surveillance of whistleblowers is bigger than previously believed, and includes tracking of sources outside the agency.

The FDA reportedly has developed an “enemies list” to push back against negative coverage of its oft-criticized review of drugs and medical devices. The list includes not only scientists employed within the FDA, but also congressmen, journalists, and outside medical researchers. These efforts have resulted in the collection of some 80,000 pages of documents that include private emails to Congress, draft whistleblower retaliation complaints, and communications with journalists and attorneys.

Senator Chuck Grassley took the lead in expressing outrage against what he previously called FDA’s “Gestapo” tactics.

Grassley’s review includes a demand for the legal memo authorizing the spying campaign, which began in mid-2010. Expect the focus to shift to FDA’s past and current chief counsels.

What’s In Your Wallet?: The Consumer Finance Protection Bureau announced its first enforcement action: a $210 million settlement with Capital One for deceptive marketing practices.

The allegations include misleading consumers about the benefits of Capital One products, which were not always depicted as optional. Some consumers were knowingly sold products they could not utilize, and others succumbed to “high-pressure tactics” to buy add-ons like payment protection and credit monitoring. In some instances, Capital One enrolled consumers in products without their consent, or led them to believe there was no additional cost.

Capital One will fully refund its customers at a cost of $140 million and pay another $25 million to the CFPB and another $35 million to the Office of the Comptroller of the Currency, totaling $210 million.

In other news, in-house corporate attorneys are concerned about CFPB enforcement actions.

Full disclosure: I have a Capital One card in my wallet.

Below the Fold:

–An environmental watchdog takes a look at Governor Romney’s anti-civil service track record in Massachusetts.

–24 percent of Wall Street executives believe they need to break the law to succeed; 16 percent would commit insider trading if they could get away with it, according to a survey done by the whistleblower law firm Labaton Sucharow.

–The Justice Department and the FBI are reviewing thousands of criminal cases to determine whether any defendants were wrongly convicted because of flawed forensic evidence. The whistleblower who first brought this to light almost 20 years ago will be monitoring progress. Legislation has already been introduced.

–A Navy whistleblower is now in charge of investigating whistleblower cases in the Defense Department.

–Penn State officials knew.

–A federal district court judge blew the whistle, in a way, about coercive plea bargain tactics that demand waiver of appeal rights in lieu of going to prison on unreasonably heavier charges.

–Some news outlets let political operatives approve quotes before they appear in print. Why not also let them write the articles?

FDA isn’t the only agency snooping on its employees.

Treasury officials, unauthorized gifts, prostitutes, and golf.

–The American Federation of Government Employees reached an agreement with the TSA to provide TSA officers personnel appeal rights at the Merit Systems Protection Board.

–The Equal Employment Opportunity Commission approved an 18-year-long race discrimination class action lawsuit brought by U.S. Marshals against the U.S. Marshal Service.

–The White House issued a memo to strengthen the rights of service members who return home and seek to reintegrate into the working force.

Send tips to dissent@dissentersdigest.com.

FDA’s spying campaign wider than previously believed

2:18 pm in Uncategorized by MSPB Watch

Even watching what you type (photo: Robbert van der Steeg / flickr)

In a story that almost defies comprehension, the New York Times is reporting that the Food and Drug Administration’s suspected surveillance of whistleblowers is bigger than previously reported, and includes tracking of sources outside the agency.

The FDA reportedly has developed an “enemies list” to push back against negative coverage of its oft-criticized review of drugs and medical devices. The list includes not only scientists employed within the FDA, but also congressmen, journalists, and outside medical researchers. These efforts have resulted in the collection of some 80,000 pages of documents that include private emails to Congress, draft whistleblower retaliation complaints, and communications with journalists and attorneys.

The FDA contracted with an outside firm to install “key logging” software in employees’ computers, which can record every key stroke and thus intercept draft letters and email passwords. The software was originally set up to collect and analyze surveillance results, but FDA officials used it to provide new leads and to map out new surveillance targets and issues of concern.

One of the congressmen on the list is Rep. Chris Van Hollen (D-MD), who is number 14. His aide is number 13.

Senator Chuck Grassley (R-IA) told the New York Times that FDA officials “have absolutely no business reading the private e-mails of their employees. They think they can be the Gestapo and do anything they want.”

An FDA contractor tasked with surveying real-time, intercepted communications apparently posted online a cache of documents by mistake. It has recently been taken down.

It is unknown if the surveillance continues to this day.

Source: In Vast Effort, F.D.A. Spied on E-Mails of Its Own Scientists

http://www.nytimes.com/2012/07/15/us/fda-surveillance-of-scientists-spread-to-outside-critics.html

Dissenters’ Digest for June 10-23

3:00 pm in Uncategorized by MSPB Watch

Stonewalled, Sen. Chuck Grassley (R-IA)

Dissenters’ Digest takes a look back at news stories covering whistleblowers, watchdogs, and government accountability. Look for it every other Saturday evening at www.dissentersdigest.com.

Contempt: A House committee voted to hold Attorney General Eric Holder in contempt for refusing to submit documents in connection with the Fast and Furious gunwalking scandal. President Obama invoked executive privilege, for the first time, to shield the documents from Congress. The measure may soon be presented to the House for a final vote. Meanwhile, Democrats are decrying the move as a political “witch hunt.”

Stonewalled: Senator Chuck Grassley is getting stonewalled by the Food and Drug Administration over an inquiry that it’s been spying on federal whistleblowers. The Senate and related House investigations were sparked by a lawsuit filed by six FDA whistleblowers who were allegedly targeted for surveillance. The National Whistleblowers Center is representing them in court. Relatedly, the Office of Special Counsel, which is also investigating the FDA over the same matter, released a memo this week to the federal government, urging agencies not to spy on whistleblowers. Doing so, the memo said, might lead OSC to conclude that retaliation is afoot.

Looking Backwards: President George W. Bush ignored a number of the CIA’s pre-9/11 warnings, according to new FOIA documents declassified and revealed this week.

Cover-Up: An Army Lt. General is accused of blocking a corruption probe in Afghanistan to help President Obama’s re-election.

Below the Fold:
Read the rest of this entry →

Dissenters’ Digest for April 1-7

2:00 pm in Uncategorized by MSPB Watch

Dissenters’ Digest takes a look back at the week’s stories covering whistleblowers, watchdogs, and government accountability. Look for it every Saturday evening at www.mspbwatch.net/digest.

Justice Department Indicts Former CIA Officer, Whistleblower, and Torture Opponent: NPR reports that John Kiriakou, a former CIA officer and outspoken torture opponent, has been charged with violating the Espionage Act by sharing secret information with reporters. The Government Accountability Project notes that Kiriakou is the first and only person to be indicted by the U.S. government who is associated with the Bush Administration’s torture program. GAP further notes that Kiriakou is the sixth whistleblower to be prosecuted by the Obama Administration. Emptywheel has additional coverage.

Watchdog Uncovers State Department Memo Casting Doubt on Legality of Bush Administration’s Interrogation Techniques: As reported by Firedoglake, a 2006 State Department memo casting doubt on Justice Department arguments approving the CIA’s “enhanced interrogation techniques” has been uncovered. The author of that memo, Philip Zelikow, was a counselor to Secretary of State Condoleezza Rice. It is believed that the Bush Administration attempted to destroy all copies of that memo, but the non-profit National Security Archive obtained one from the State Department through a Freedom of Information request. Emptywheel has additional coverage. Zelikow’s memo can be found here.

New York Times Report Portrays FDA as Victim of White House Politicization: The New York Times reports that FDA officials were instructed to reverse decisions such as publicizing the caloric content of movie-theater popcorn. The overall tenor of the piece portrays White House officials as shrewd and pragmatic, with FDA officials seen as public-minded, if not “naive.” However, there may be some image management going on following recent and troubling reports of retaliation and spying on whistleblowers, who came forward to allege corruption within FDA and the improper approval of unsafe medical devices. The Office of Special Counsel has opened an investigation into these allegations. GAP and the National Whistleblowers Center have coverage of the FDA.

Below the Fold:

–President Obama signs the STOCK Act, requiring financial disclosure by members of Congress and federal executives.

–Lavish Las Vegas conference costs top GSA officials their jobs. Congress is said to investigate.

–The Obama Administration quietly appoints a new FAA chief counsel with extensive ties to the White House.

–EEOC is urged to tackle conflicts of interest in discrimination complaint process.

–The U.S. government aims to protect secrecy in Bradley Manning’s court martial.

–The Office of Special Counsel is currently experiencing an 8-9 month delay in processing FOIA requests, according to recent communications with its FOIA officer.

Send tips to info at mspbwatch dot net.

Comparison of whistleblower stay requests: OSC vs. IRA

5:57 pm in Uncategorized by MSPB Watch

Last month, and to much fanfare, the Office of Special Counsel successfully sought from the Merit Systems Protection Board “stay requests” putting a hold on adverse personnel action against two whistleblowers.

In one case, OSC sought a 45-day stay on the proposed indefinite suspension without pay of Franz Gayl, a civilian advisor to the Marines. In another case, OSC sought a stay for the termination of Paul T. Hardy, an FDA adjunct employee who objected to the improper approval of a medical device.

Legal Authority

The authority for such requests through OSC stems from 5 U.S.C. 1214(b)(1)(A)(i), which states that

The Special Counsel may request any member of the Merit Systems Protection Board to order a stay of any personnel action for 45 days if the Special Counsel determines that there are reasonable grounds to believe that the personnel action was taken, or is to be taken, as a result of a prohibited personnel practice. [Emphasis added.]

This is codified in MSPB practice regulations, specifically 5 C.F.R. 1201.134(a), which states that

Request to stay personnel action. Under 5 U.S.C. 1214(b)(1), the Special Counsel may seek to stay a personnel action if the Special Counsel determines that there are reasonable grounds to believe that the action was taken or will be taken as a result of a prohibited personnel practice [Emphasis added.]

However, due to budget constraints, OSC is not able to represent most federal whistleblowers who suffer retaliation. Because of this, whistleblowers are granted the right to pursue their own Individual Right of Action (IRA) — granting them the right to sue the retaliatory agency in the MSPB pro se or with a private attorney.

Whistleblowers on an IRA also have the right to request stays from MSPB, pursuant to 5 U.S.C. 1221(c):

(1) Any employee, former employee, or applicant for employment seeking corrective action under subsection (a) may request that the Board order a stay of the personnel action involved.

This too is codified in MSPB practice regulations, under 5 C.F.R 1209.9(a)(6)(iii)

(a) Only an appellant, his or her designated representative, or a party properly substituted under 5 CFR 1201.35 may file a stay request. The request may be in any format, and must contain the following:

(6) Evidence and/or argument showing that:

(iii) There is a substantial likelihood that the appellant will prevail on the merits of the appeal; [Emphasis added.]

This difference in language is not insignificant; it raises the evidentiary bar for whistleblowers who are not represented by OSC. Moreover, MSPB’s “substantial likelihood” language may be contrary to Congress’ intent.

Legislative History

In 1988, when Congress was debating passing the Whistleblower Protection Act, the Senate Governmental Affairs Committee Report 100-413 stated the following:

S.508 would remove the monopoly the OSC has over many cases involving employees alleging reprisal for whistleblowing. The bill would provide that whistleblowers who are presently confined to using the OSC can individually petition the MSPB if the OSC terminates its investigation of the employee’s case or if the OSC fails to commit to pursuing the case within 90 days of receiving the complaint.

Whistleblowers filing with the Board through this individual right of action may also request the Board for a stay of the pending personnel action. It is expected the Board will be fairly liberal in granting these stays, since they would be only temporary and would not significantly affect the agency’s functioning.

That being said, what is the MSPB’s record in granting stay requests?

MSPB Statistics

In practice, MSPB only grants about 2 percent of the stay requests it receives, based on a FOIA request for FY 1994-FY 1998.* (A request for more recent data is in progress.) Compounding this problem, MSPB in its annual reports to Congress lists the number of stays requested but not those granted or denied. This is in contrast to every other category of decision it makes. See, e.g., Table 1 on page 25 ofMSPB’s FY 2010 Annual Report to Congress and compare with Table 2 on page 26. Compare with other Annual Reports here.

In addition, for the time period 1994-2000, MSPB denied IRA stay requests in 140 cases in which the requestor later got relief, but granted a stay in only one case where the requestor did not later get relief. This and the 2% statistic above support the contention that MSPB is not “fairly liberal” in granting stays, as imagined by Congress.

Why is this Important?

If federal whistleblowers received stays “liberally,” by newly enacted legislation such as the Whistleblower Protection Enhancement Act currently being debated in Congress, then agencies would be motivated to settle fairly instead of the whistleblower being forced into accepting unfair and one-sided settlements, as is the case when agencies approach the negotiating table. This is largely a function of an inability to retain an attorney and finance the tens of thousands of dollars required to achieve justice in this system.

Possible Remedies

Legislation such as H.R. 3289 and S. 743, the House and Senate versions of the Whistleblower Protection Enhancement Act, should direct MSPB to use “reasonable grounds to believe” as the evidentiary standard in whistleblower stay requests made as part of an IRA appeal.

Another remedy is for MSPB, upon request or sua sponte, to change rule 5 C.F.R 1209.9(a)(6)(iii) to provide parity between OSC petitioners and IRA petitioners.

*Many thanks to Joseph Carson for providing this information.

Cross-posted at MSPB Watch.