Tag Archives: sebelius

FDA staff calls for end to corruption, wrongdoing

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Scientists and doctors with the FDA have sent a strongly worded letter to President Barack Obama calling for “sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long.”

Excerpt of letter send by FDA staff.

Excerpt of letter send by FDA staff.

The letter, released in conjunction with a Senate finance committee hearing over Kansas Gov. Kathleen Sebelius’ nomination to be secretary of the U.S. Department of Health and Human Services, cites a number of times in which FDA officials rejected the opinions of the scientific staff.

It also details a culture in which the staff feared retaliation for speaking out to the media and to Congress. The letter notes that several FDA officials it says were guilty of wrongdoing have recently left the agency but “the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.”

The FDA employees advise the president to take action:

The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General.

Update

There have been some questions about why the names of the FDA scientists have been blacked out on these letters. Grassley explains in his statement that he did this to protect them from retaliation:

These letters are from a group of nine scientists at the FDA. They are writing for a second time to President Obama today regarding their grave concerns about the FDA. Governor Sebelius, I want to be sure that you aware of these concerns from whistleblowers inside the agency. I also want to note that I am providing copies for the record that do not identify the whistleblowers by name. They are afraid of retaliation particularly in light of the former acting FDA Commissioner’s recent statements and the President’s recent signing statement that seems to limit whistleblower protections.

Sebelius to testify at Senate committee hearing

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Kansas Gov. Kathleen Sebelius is expected to testify in a hearing in front of the Senate finance committee this morning in a hearing to consider her nomination to be secretary of the U.S. Department of Health and Human Services.

Sen. Max Baucus of Montana and Sen. Charles Grassley of Iowa are expected to make statements at the hearing.

UPDATE: See webcast of the hearing.

Watch Sebelius confirmation hearing

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

Sen. Edward Kennedy has opened the confirmation hearing for Kansas Gov. Kathleen Sebelius to become the secretary of the Department of Health and Human Services before the Committee on Health, Education, Labor, and Pensions. Opening comments and testimony (PDF) are available.

Sebelius coverage focuses on experience, abortion

She tries to work with both Republicans and Democrats, but is inexperienced when its comes to working with Congress. And her support for abortion rights is a flashpoint that will generate serious protest. These are among the observations from various corners now that President Barack Obama has nominated Kansas Gov. Kathleen Sebelius as U.S. Health and Human Services Secretary.

Several AHCJ members and staff visited Sebelius in Topeka on April 21, 2008, as part of AHCJ's Midwest Health Journalism Program Fellowships.

Several AHCJ members and staff visited Sebelius in Topeka on April 21, 2008, as part of AHCJ's Midwest Health Journalism Program Fellowships.

For instance, USA Today points out that Sebelius would bring “expertise as a former state health insurance regulator but not deep ties to the members of Congress who will decide the fate of the president’s health care proposals.” The paper quotes Norman Ornstein of conservative think tank American Enterprise Institute as saying “it’s a tough job for anybody to do right now,” but especially for a Washington outsider. “It’s like suddenly being inserted as quarterback in the second quarter of the Super Bowl, where you know the coach, you know the game, but you haven’t played with this team and you don’t know all the plays.”

On the other hand, CNNPolitics.com notes that Sebelius has “experience working with both Democrats and Republicans in her home state, which could be an asset to President Obama as he embarks on an effort at bipartisanship in reforming health care.”

The experience, however, may have been sobering, according to The New York Times, which pointed out that her “efforts to forge bipartisan consensus have rarely succeeded. She recently observed that the greatest frustration of her six years in office had been her inability to persuade lawmakers to raise tobacco taxes for a modest expansion of government health coverage.”

Meanwhile, The Washington Post writes that Sebelius, who was raised as a Roman Catholic in Ohio, has “endured fierce and often personal criticism from anti-abortion activists largely because she vetoed a bill that would have required doctors who perform late-term abortions to report a reason for the procedure.” The paper adds that, after the veto, the archbishop of Kansas City asked her to stop taking Communion. Underscoring the point, FoxNews.com reports how anti-abortion activists plan to fight her nomination.

Beyond the mainstream, blogs are reacting with passion. Catholic Fire writes that it would “certainly be good to get her out of Kansas.” On the other end of the spectrum, Women’s Voices for Change is thrilled that Sebelius was chosen for HHS and calls her a “Mistress of the Universe,” who is a tough administrator, deeply bipartisan and determined to get things right, even when faced with unpopular choices.

Related

Reports: Kansas governor Sebelius to lead HHS

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

The Associated Press is reporting that a White House source says Kansas Governor Kathleen Sebelius is President Obama’s choice to lead the Department of Health and Human Services.  The New York Times reports that Sebelius will be introduced by Obama on Monday.

Several AHCJ members and staff visited Sebelius in Topeka on April 21, 2008, as part of AHCJ's Midwest Health Journalism Program Fellowships.

Several AHCJ members and staff visited Sebelius in Topeka on April 21, 2008, as part of AHCJ's Midwest Health Journalism Program Fellowships.

According to AP, “Sebelius drew praise for the consumer watchdog role she played as Kansas insurance commissioner for eight years before she became governor.” Sebelius, an early Obama supporter, is in her second term as governor and cannot seek a third term.