Today's Article
The FDA's decision
not to test many
medical devices 'is a
high-stakes,
unknown-odds gamble
with the lives of
patients,' states a
POGO study.
not to test many
medical devices 'is a
high-stakes,
unknown-odds gamble
with the lives of
patients,' states a
POGO study.
The American Spark
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FDA Not Testing Medical Products
By Cliff Montgomery Feb. 22nd, 2009
Since 2006, the Food and Drug Administration (FDA) has failed to guarantee that such essential medical
devices as replacement heart valves, cardiac defibrillators, pacemakers and coronary artery stents are
properly tested, according to federal documents obtained by the Project On Government Oversight (POGO), a
government watchdog group.
The papers also show that top officials at the FDA's Center for Devices and Radiological Health (CDRH)--
which is supposed to oversee medical device safety--deliberately decided on this 'do-nothing' path that puts
numerous Americans' lives at risk.
Readers may download the entire fascinating POGO report, released on Feb. 18th, or read the short Executive
Summary from the POGO study, which The American Spark quotes below.
Executive Summary
This report by the Project On Government Oversight lays out a case against the officials in charge of a Center
of the Food and Drug Administration—the Center for Devices and Radiological Health (CDRH)—charged with
overseeing the safety of medical devices. A crucial internal document of August 2006 obtained by POGO
reveals a decision made by senior CDRH officials that puts patients' lives at risk. These officials decided,
without public notice, to ignore the long-standing Good Laboratory Practice (GLP) regulation.
The GLP regulation sets specific requirements for the testing of medical devices, including life-sustaining
devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents.
The requirements for GLP testing are supposed to be met before CDRH deems these devices safe enough to
be implanted in humans for the first time. But with CDRH ignoring the enforcement of the regulation,
manufacturers and testing facilities are now trusted to monitor their own GLP compliance.
CDRH's decision to not enforce the GLP regulation has weighed heavily on Center scientists, many of whom
believe that enforcement is required not only on regulatory but also on ethical grounds.
In 2006, the head of CDRH's Division of Bioresearch Monitoring confronted Center management about the
lack of enforcement. The response was swift and decisive—there would be no return to the previous policy of
enforcement.
That CDRH would not be enforcing the GLP regulation was reiterated by a Center employee at a meeting of
the Society of Quality Assurance, a position that astonished those in attendance.
The decision by top CDRH officials to not enforce the GLP regulation is stunning in its contempt for the
protection of patients and its indifference to standards that comply with federal regulations.
Their decision, which was made over the strong objections of CDRH scientists, is no harmless blunder. It is a
high-stakes, unknown-odds gamble with the lives of patients. It was also made without public notice.
The deliberate disregard of the GLP regulation can be understood better when viewed as one of a range of
serious problems in the FDA as a whole.
The FDA's troubles start with its budget, which has not kept up with its growing responsibilities. For years, the
agency has been under-funded, understaffed, and overworked. The gross inadequacy of the FDA's budget
has resulted in an agency that "can no longer fulfill its mission without substantial and sustained additional
appropriations."
Some critics of the FDA say that manufacturers' requests for evaluation of drugs and devices are processed
by the FDA too hastily and with a bias toward approval. They see the FDA leadership as frequently bowing to
political influence and to the wishes of the industry it regulates, leading the agency to exert improper pressure
on FDA scientists during their process of evaluating the safety of medical devices.
The FDA's mission—to protect the public health—depends on vigorous oversight and enforcement as a matter
of agency policy. When the FDA fails to enforce certain regulations, the consequences can be lethal.
Summary of Recommendations
Like what you're reading so far? Then why not order a full year (52 issues) of the The American Spark e-
newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!
By Cliff Montgomery Feb. 22nd, 2009
Since 2006, the Food and Drug Administration (FDA) has failed to guarantee that such essential medical
devices as replacement heart valves, cardiac defibrillators, pacemakers and coronary artery stents are
properly tested, according to federal documents obtained by the Project On Government Oversight (POGO), a
government watchdog group.
The papers also show that top officials at the FDA's Center for Devices and Radiological Health (CDRH)--
which is supposed to oversee medical device safety--deliberately decided on this 'do-nothing' path that puts
numerous Americans' lives at risk.
Readers may download the entire fascinating POGO report, released on Feb. 18th, or read the short Executive
Summary from the POGO study, which The American Spark quotes below.
Executive Summary
This report by the Project On Government Oversight lays out a case against the officials in charge of a Center
of the Food and Drug Administration—the Center for Devices and Radiological Health (CDRH)—charged with
overseeing the safety of medical devices. A crucial internal document of August 2006 obtained by POGO
reveals a decision made by senior CDRH officials that puts patients' lives at risk. These officials decided,
without public notice, to ignore the long-standing Good Laboratory Practice (GLP) regulation.
The GLP regulation sets specific requirements for the testing of medical devices, including life-sustaining
devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents.
The requirements for GLP testing are supposed to be met before CDRH deems these devices safe enough to
be implanted in humans for the first time. But with CDRH ignoring the enforcement of the regulation,
manufacturers and testing facilities are now trusted to monitor their own GLP compliance.
CDRH's decision to not enforce the GLP regulation has weighed heavily on Center scientists, many of whom
believe that enforcement is required not only on regulatory but also on ethical grounds.
In 2006, the head of CDRH's Division of Bioresearch Monitoring confronted Center management about the
lack of enforcement. The response was swift and decisive—there would be no return to the previous policy of
enforcement.
That CDRH would not be enforcing the GLP regulation was reiterated by a Center employee at a meeting of
the Society of Quality Assurance, a position that astonished those in attendance.
The decision by top CDRH officials to not enforce the GLP regulation is stunning in its contempt for the
protection of patients and its indifference to standards that comply with federal regulations.
Their decision, which was made over the strong objections of CDRH scientists, is no harmless blunder. It is a
high-stakes, unknown-odds gamble with the lives of patients. It was also made without public notice.
The deliberate disregard of the GLP regulation can be understood better when viewed as one of a range of
serious problems in the FDA as a whole.
The FDA's troubles start with its budget, which has not kept up with its growing responsibilities. For years, the
agency has been under-funded, understaffed, and overworked. The gross inadequacy of the FDA's budget
has resulted in an agency that "can no longer fulfill its mission without substantial and sustained additional
appropriations."
Some critics of the FDA say that manufacturers' requests for evaluation of drugs and devices are processed
by the FDA too hastily and with a bias toward approval. They see the FDA leadership as frequently bowing to
political influence and to the wishes of the industry it regulates, leading the agency to exert improper pressure
on FDA scientists during their process of evaluating the safety of medical devices.
The FDA's mission—to protect the public health—depends on vigorous oversight and enforcement as a matter
of agency policy. When the FDA fails to enforce certain regulations, the consequences can be lethal.
Summary of Recommendations
- Congress or HHS IG should conduct an investigation of the decision made by senior CDRH officials to
ignore or deemphasize enforcement of the GLP regulation without prior public announcement.
- The GAO or the HHS IG should audit those records related to GLP which may contain evidence of
device manufacturers' compliance or noncompliance with the GLP regulation.
- After auditing has established the facts, CDRH should implement a program of GLP enforcement.
- If serious violations of the GLP regulation are found, either during the audit recommended here or after
resumption of enforcement actions by CDRH, the range of possible responses should extend beyond
the usual Warning Letter and should include referral for possible criminal prosecution if circumstances
warrant it.
- The possible role of GLP non-compliance should be considered whenever a device malfunctions either
during clinical testing or after marketing.
- Senior FDA officials should require full transparency in all agency actions other than those whose public
disclosure is prohibited by regulation or law.
- Congress should pass legislation and the President should issue an Executive Order to strengthen
federal employee whistleblower protections.
- Congress should pass legislation that would make lawsuits by injured patients possible.
- Congress and the administration should at least double the budget of the FDA by 2012.
Like what you're reading so far? Then why not order a full year (52 issues) of the The American Spark e-
newsletter for only $15? A major article covering an story not being told in the Corporate Press will be
delivered to your email every Monday morning for a full year, for less than 30 cents an issue. Order Now!
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