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Aug 12, 2009

Comments

Dr. Smith

At a 2010 SQA meeting, CDRH officials indicated that they plan to inspect five labs. CDRH approved over 2500 applications last year. It is an improvement over 1 laboratory in 2008 and 4 in 2009.

e cigarette

I am beginning to really lose all faith and credibility in the FDA. It seems to me that instead of focusing their efforts on protecting the general public they are in-turn being influenced by corporate agenda and special interest. I take everything they say with a grain of salt.

Bryan Rahija

Dr. Johnson and Dr. Paller,

Thank you both for weighing in on this discussion. It's clear from this comment section that you all aren't alone in your concerns.

If any of readers have any experiences related to fraud or corruption, may contact us about them here:

http://www.pogo.org/report-corruption/


Bryan

Dr. V Johnson

Bryan

Numerous FDA scientists are hoping that POGO's meeting with the FDA Commissioner is successful. FDA Commissioner Hamburg must investigate the corruption at CDRH. CDRH cannot police itself. Its matrix post-market surveillance is a debacle – full with cronies; mainly from one offide in the Center. Many scientists who differed in opinion from management were threatened with disciplinary action. CDRH has gone out of its way to reward and even promote staff to reinforce negative behaviors: denying promotions, discouraging opportunities for advancement, and exiling talented scientists. For example, in 2007, it is widely known in CDRH that management denied a peer-review promotion of its Center's GLP expert and ostracized the scientist after he reported problems, including omissions in studies supporting numerous applications to management that could result in injury and death. After the expert's expulsion, the GLP Program was closed. Its own records will disclose these facts.

American people are at risk. Dr. Margaret Hamburg must order an OIG investigation of all practices and policies relating to your report. Dr. Hamburg should contact Congress to initiate a GAO audit. NTEU should investigate violations of labor laws. FDA should not value profit of industry over the health of the American public.

Dr. Paller

It is not all CDRH. The trend over the past 5 years is fewer not more GLP device inspections. Not all FDA regulated products are equally evaluated and protected. FDA has always favored pharmaceuticals (drugs and some biologics) over devices, and devices over foods. GLP device inspections represents a minuscule fraction of Bioresearch Monitoring inspections and foods even less. It is estimated that less 10 percent of all BIMO GLP inspections are devices; less than 3 percent for foods.

In last ten years, CDRH has devices inspections than CBER and CVM combined, even though these centers regulate devices. FOIA group and ORA acknowledged this fact. The February 2009 report fails to disclose the lack of enforcement for all centers with oversight of devices. The gamble of safety is not isolated to CDRH. CDRH has been more outspoken about it.

I agree with bloggers. CDRH leaders (supervisors and managers) are an assembly of unindicted criminals. Good employees were driven away. Politics preempt public health.

The American public needs to know the extent of the relaxed enforcement of GLP. Bryan, is there a sequel?

W Cho


CDRH needs reorganization rom the bottom up. CDRH does not need more authority. It has more power than it deserves to wield. It needs to prove that it can eliminated corruption and knows how to better manage the resources (and authority) it already has.

Dr. A. Swanson

Bryan,

I hope POGO's meeting with the FDA Commissioner is productive. If there's anyone with a justified reason to be very disappointed with FDA, it's new FDA Commissioner. FDA supposed to be a public health organization. Yet, CDRH's leadership believes they are above the law and subject to no rules whatsoever.

I saw your earlier blog. Employees are afraid to contact POGO or Congress. CDRH threats its staff just as CDER once threatened Dr. David Graham, and it will use every intimidation tactic at its disposal to discredit, dismiss, or demote any employee who dares challenge the power and authority.

CDRH has wonderful employees - dedicated scientists trying to save people's lives by making FDA approvals based on solid science and law. Instead, they're being routinely overruled by politics; which they know will result in the loss of human life as consumers are harmed or killed by dangerous combination products, electronic products, and medical devices.

Bryan Rahija

Dr. Swanson,

We are working on setting up a meeting with the Commissioner to discuss the issues you mentioned: transparency, accountability, and not the least of which, protection and recognition of whistleblowers. We're always looking out for instances where GLP is not followed—as far as I know, we have not published specific data regarding CBER and CVM adherence to GLP.

and to W Cho,

Indeed, the issue of whistleblower intimidation will not vanish with the departure of one administrator. We would certainly welcome any OIG or GAO audits.

Thank you for the comments!

If any readers would like to contact POGO I would refer them to this earlier post:

http://pogoblog.typepad.com/pogo/2009/03/fdas-oversight-of-medical-devices-congressional-interest.html

W Cho

The removal of Dr. Schultz will not create reform. The culture of intimidation and harassment is deeply embedded. Staff will continue to be ordered to modify scientific evaluations, conclusions, and recommendations. Managers will still accept data that is not scientifically valid and allow false statements in documents. I do not believe any manager in ODE and OC will ever face the consequences of their actions. Cronies are typically rewarded, not fired. Complainers are asked to leave.

POGO reported that CDRH completed only one GLP Bioresearch Monitoring inspection in 2008/2009. How many inspections did CBER and CVM perform to verify the safety of devices? I do not know. Bryan, do you know? It is probable that the attitude towards the safety of devices - human medical devices and electronic products, veterinary devices, and blood bank devices - are universal.

HHS OIG and GAO audits are needed. These audits must extend to include the records of all centers that oversee devices so that full disclosure of the risk to public health are known and meaningful improvements adopted.

Dr. A Swanson

Devices are reviewed by three centers. The Center for Biologics Evaluation and Research (CBER) reviews devices used in blood banking operations, CDRH reviews human medical devices, and the Center for Veterinary Medicine (CVM) reviews veterinary devices. Has POGO investigated the actions of CBER and CVM regarding premarket clearance of devices and GLP? I doubt the problems are limited to CDRH.

Dr. A Swanson

I agree with Dr. Feder's commentary and other bloggers. The first critical step in ANY reform is for FDA Commissioner Margaret Hamburg to quickly and openly correct the harm caused by retaliation against CDRH whistleblowers who have reached out to the Congress, the media, and public interest groups.

FDA must be transparent, equitable, accountable, trustworthy, and respectful in its decisions with employees and the American public. The American public has a right to know the devices approved by CDRH for marketing and research (clinical trials) based on false and misleading information. GAO and OIG audits are needed.

Bryan, has anyone in POGO addressed this matter recently with the FDA Commissioner or with Congress? Has anyone contacted FDA Transparency Task Force?

Bryan Rahija

Thank you for your comment—here's hoping that Commissioner Hamburg can help create a climate that protects and values its whistleblowers. Unfortunately, a lack of adequate funding exacerbates all of these problems. In fact, we've suggested that the agency requires three times it's current operating budget in order to do its job. The extra funding would go a long way to ensure the FDA can perform adequate testing, not to mention help shield the agency from influence by non-scientific actors.

Average Scientist

King Schultz is gone; however, his circle remains. A GAO or OIG is still needed to uncover whether any FDA activity has compromised the health and safety of America consumers.

I commend the FDA scientists; particularly the whistleblowers and the authors of the August 31, 2006, memorandum identified in your report, for courageously sounding the alarm on what appears to be a very serious problem.

However, some scientists were driven out of CDRH, including the Center's former GLP expert, for investigating criminal activity (bribery, fraud, and research misconduct) in applications. Their investigations raised serious questions about the scientific integrity of the FDA medical device approval process. Dr. Michael Marcarelli, Mr. Timothy Ulatowski, and Dr. Donna Bea Tillman know who they are. I look forward to return of these dedicated public servants. CDRH needs all of its talented employees to ensure that the medical devices Americans depend on are safe and effective.

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