FDA's Oversight of Medical Devices: Congressional Interest
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On February 18, POGO released a report, "The FDA's Deadly Gamble on the Safety of Medical Devices." An Appendix to the report contains excerpts from chilling statements made to POGO, anonymously, by scientists in the FDA. They describe a climate of fear in which they and other FDA scientists are sometimes not able to take the most obvious steps to protect patients in clinical trials (and ultimately the public) from inadequately tested and possibly unsafe medical devices such as cardiac pacemakers, internal defibrillators, artificial heart valves, and coronary artery stents. This blog post is addressed primarily to those scientists who wrote POGO previously, in case one or more of you decide to contact POGO again.
The POGO report on medical devices has attracted attention in the press (AP, Reuters, McClatchy, and U.S. News & World Report) and on Capitol Hill. For several years lawmakers concerned about the decline of the FDA have been considering specific legislative remedies. In recent private discussions with POGO staff, senior aides who are investigators for a congressional committee have expressed an interest in talking confidentially with some of POGO's sources.
It is possible that one or more of you would like to assist these congressional investigators. If so, please contact one of the undersigned, either by phone or email, so that we can provide specific information about how to do this and how to best protect yourself. Do not use a government phone or computer or other government resources when you contact us.
Ned Feder, M.D., Staff Scientist, nfeder@pogo.org
Danielle Brian, Executive Director, danielle@pogo.org
Project On Government Oversight
1100 G Street, NW
Washington, DC 20005
http://www.pogo.org
202-347-1122
You stated that FDA conducted 33 inspections of these early testing labs in 2005, seven in 2007 and one in 2008. None were scheduled for 2009. Based on your evidence, the internal decision to scale back lab inspections occurred before 2006 - the date in your report; perhaps as earlier as 2005. Nelson Labs received the last Warning Letter (2005) from CDRH. See FOIA website.
What happen in CDRH or FDA in 2005 to precipitate the need for the memo? Maybe CDRH or FDA began the relaxed enforcement of laboratories during that year.
One should investigate how many lab inspections classified as OAI but did not result in a Warning Letter from CDRH to the firm? How many lab inspections are actually OAI based on the severity of noncompliance but were down-classified to NAI and VAI? How many applicants were caught by CDRH lying in their (GLP) compliance statement? Are these outcomes restricted to CDRH or systemic throughout FDA?
Your report focused on CDRH, but it did not incorporate failings of Center for Veterinary Medicine (CVM). According to FDA website, CVM is responsible for veterinary medical devices – that’s 100+ species to 1 species for CDRH. If CVM can evaluate the safety and efficacy of new animal drugs, CVM can evaluate the safety and effectiveness of medical devices for animals. Why are there no regulations for a premarket application for veterinary devices or a 510(k) for veterinary devices? Have you investigated CVM and determine what actions, if any, has been performed to safeguard American consumers, their companion animals, and the food animals from untested and ineffective medical devices and materials?
Do veterinarians take an oath to ‘do no harm’ to animals? A large percentage of professionals in CVM including its director Dr. Bernadette Dunham are veterinarians. Are they betraying the animals and their profession by allowing untested veterinary products into the market?
If CDRH are not enforcing GLP regulations in its review of all medical device submissions and CVM has no premarket requirements for medical devices to enforce GLP, there ARE NO CHECKS by FDA that medical devices SOLD IN AMERICA ARE SAFE. If CDRH resumes enforcement, there will still be hundreds of untested - perhaps defective - devices in the market unless CVM creates an application to review veterinary medical devices and both have a rigorous post-market surveillance program.
What is FDA’s mission? Is it a public health agency? American consumers and pet owners trusted FDA to protect them and their pets.
Commissioner must investigate these scandals. Congress must investigate these scandals. America deserve better. These scandals could jeopardize healthcare reform and the nation’s confidence in government.
Posted on: Jun 15, 2009 at 03:30 AM
Many scientists who differed in opinion from management were threatened with disciplinary action. Some were exiled, denied promotions, and discouraged to pursue opportunities for advancement.
No one has ever been held to accountable for the corruption. CDRH has gone out of its way to reward and even promote staff to reinforce negative behaviors. American people are at risk. Dr. Margaret Hamburg must order an OIG investigation of CDRH's practices and policies and ALL records relating to your report. Dr. Hamburg should contact Congress to initiate a GAO audit. NTEU should investigate violations of labor laws.
Posted on: Jun 14, 2009 at 11:42 PM
The objectives of the CDRH's bioresearch monitoring program are twofold: (I) to ensure the quality and integrity of data and information submitted in support of investigational and marketing clearance applications or submissions [IDEs, PMAs, and 510(k)s]; and (II) to ensure that human subjects taking part in investigations are protected from undue hazard or risk. Although these objectives are clear, the management of this program ordered, intimidated and coerced staff to modify their scientific reviews, conclusions, and recommendations; some staff were transferred or terminated for executing ethical decisions. The FDA Commissioner must investigate to determine the justification for such decisions.
Posted on: Jun 14, 2009 at 11:06 PM
POGO should contact FDA Commissioner Hamburg to investigate the corruption at CDRH. CDRH cannot police itself. CDRH Senior management must be replaced. CDRH supervisors and managers cannot be trusted. Knowledgeable persons were expelled. Its own records will disclose these facts.
For example, In 2007, CDRH management ostracized the Center's GLP expert after the person reported problems in studies supporting IDE and PMA applications to management. After the expert's expulsion, the GLP Program was closed.
Posted on: Jun 14, 2009 at 03:57 PM
From sources at CDRH, the internal memorandum quoted in your February 2009 report was cleansed of known facts about the deaths and injuries resulting from the approval of products described in the memorandum. Everyone will know if GAO and OIG interview the Office of Device Evaluation and Office of Compliance. CDRH employees are afraid to speak out. Many have witnessed the black-listing of colleagues.
Posted on: May 17, 2009 at 05:02 PM
CDRH issued only one GLP inspection in 2008, so did CFSAN (human foods) issued only one GLP inspection for 2008.
Posted on: May 06, 2009 at 10:14 PM
People pay 1000's of dollars for their pets. FDA's mission statement is phony. Are there any combination products for both human and animals?
Also why are FDA scientists reviewing labeling of medical devices if they are not reviewing the materials? No premarket approval = No good laboratory practice, no good clinical practice, and no good manufacturing practices.
No cardiac pacemakers, internal defibrillators, artificial heart valves, coronary artery stents, and nanotechnology products ever reviewed and tested for sold on the market.
Animal devices are not excluded to companion animals. Imagine milk and beef cattle implanted with unsafe medical devices and the toxic effects of materials are passed to the unsuspected owners and buyers who consumed the milk and meat?
Posted on: May 04, 2009 at 11:46 PM
FDA CDRH is not the only one. Check out FDA website about animal devices. Companion animals do not have a chance: no medical device approval, listing, or registration.
Posted on: May 04, 2009 at 11:26 PM