The House Energy and Commerce Committee receiveda letter dated October 14 from a 'large group' of scientists and physicians at the FDA's Center for Devices and Radiological Health division, who complained that CDRH managers have "corrupted and interfered with the scientific review of medical devices."
In a statement, John Dingell, who chairs the committee, and Bart Stupak, who chairs the Subcommittee on Oversight and Investigations, say they are probing allegations that the FDA "approved or cleared medical device applications in gross violation of laws and regulations....such activity could allow potentially unsafe and ineffective medical devices into the US market."
The CDRH allegedly "ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law." The CDRH staffers also claim they were forced to use "unsound evaluation methods, and accept clinical and technical data that is not scientifically valid or obtained in accordance with legal requirements, such as obtaining proper informed consent from human subjects.”
And in a letter to FDA commish Andy von Eschenbach, the lawmakers note that the same CDRH employees wrote last May to FDA officials to complain, and that William McConagha, assistant commissioner for integrity and accountability, investigated the allegations and recommended removing some CDRH managers.
Although McConagha called the "evidence is 'compelling,’ ‘convincing,’ and ‘sufficient’ to justify disciplinary and curative actions," Dingell and Stupak say no action has been taken, and that retaliatory behavior against the employees occurred.
48 Comments
Ignoring science, safety, regulations, and retaliation again. Just business as usual at FDA.
Can't confirm it but I heard another reviewer, a medical officer this time, was escorted from the building by security this past week for raising safety issues or talking to congress. This is the second person in 3 months that I know of in addition to the pediatric psychopharmacologist.
I would have thought with all the noise congress has made about this that they would have at least released a letter to FDA managment.
Congressman Stupak,.. Parents across the United States hold you in the "highest Regard". We Thank You for keeping patient safety on the front burner!!!!!
Anyone want to defend the Supreme Court's Riegel decision, which upheld preemption in the device arena by an 8-1 vote, if these allegations are confirmed?
When the Riegel decision came down, preemptors both rejoiced and wrote reflective blogs about the FDA's "big responsibility" now that preemption had been affirmed for FDA-approved devices.
If we learn, yet again, that that repsonsibility has been betrayed - as many of us declared a certainty - what should our own response?
Ed - Do you happen to have a link to the letter (probably hasn't been made public) and/or responses of Dingell/Stupak? Thanks!!
Hi Justice,
I've just included the links. Sorry about that. They only just became available.
Best ed
This is great news! You think CDER has issues? The CDRH has them trumped tenfold. Hard to imagine, but device manufacturers are at a bottom-feeding level that even pharma can't attain. Go Dingel!
I hope President Obama appoints an Attorney General who'll send an army of FBI agents into each one of these Pharma criminal enterprises and haul the executive management committee members and board of directors out in handcuffs.
To see a different Pharma felon do a "perp walk" every day on the nightly news would make for some damn good TV!
Politics as usual. When the Dems start filling posts at the FDA, you guys watch to see if they will go after their own kind, all in the name of "patient safety."
I'm not sure I follow Random Walk's point. Is it that corruption of this sort is inevitable given the politization of FDA? That intimidation (and worse) of reviewers will go on, regardles? And/or, there is nothing to this, and it is all "politics"?
Gretchen,
I don't know if CDRH has it 10 times worse than CDER or not. Having your kids threatened is not something that I would wish on anyone. There's a lot of bad in all areas. I heard from different contacts about significant problems in CDRH a couple of years ago, as well as problems in biologics, blood banking, food, and the field. It's a systemic problem and the managers at the top who oversee all of it (like Woodcock) need to be held accountable. We've got a big job ahead of us to try to get it back to something even half-way reasonable and all the industry plants down to the very lowest levels are going to make it extremely difficult. Very few of them have done documentable things that would allow them to be eliminated. The Hydra will raise its' head again somewhere down the line.
Justice, you ask what our response should be concerning the current state of affairs that stand side by side with the preemption efforts... Of course the obvious things but one that maybe we haven't address enough has to do with our major media. Where are they? We have to begin to *demand* that our major public media address this issue. If they continue to ignore this issue it appears to me that they are willfully refusing to report on one of the most important issues of our times. It's time that we begin to question their motives. For me silence speaks volumes. The silence of preemption supporters (not withstanding our friends Nathan and others) is one example, the silence of our major media outlets is another.
If a story that involves The Supreme Court, Congress, The FDA, political influence, corruption, whistle blowers, one of the largest industries in the world and the American consumer is not enough to lead someone to do some serious investigative reporting, we have to assume the worst. I call on the NBC, CBS, ABC, Fox News and the rest to either report in prime time or tell us why they decline to report. If they decline we should hold them responsible as one of the parties involved in allowing preemption to be perpetrated on the uninformed citizens of our country.
Where's the petition?
Salmon, We can get a petition going but I think a better idea is to write to every major media commentator that we can find. Please copy and past into their email this letter or one of your own.
Dear ___________, Maybe you can tell me. Why aren’t the major media reporting in prime time the story about FDA preemption – which is policy that has circumvented Congressional lawmaking by the FDA and The Supreme Court? Policy that says simply if your drug or device is approved by the FDA you have freedom from product liability law suits (state tort). The justification for this elimination of our civil right to a day in court is that the FDA is the one and only able to determine what is safe and what is not safe to consume. http://www.cnbc.com/id/15840232?video=912767189
Today we find out that Congress has been informed by FDA staff (whistle blowers) that they have been coerced, threatened and otherwise caused to approve medical devices without support of their findings and good science. That FDA management has allowed unsafe medical devices to be approved for sale to the American public. http://www.pharmalot.com/2008/11/congress-probes-corrupted-fda-device-approvals/
Please explain to me why this isn’t as important as some Congress person taking a low interest loan for their home or their political campaign or a millionaire being charged with insider trading? I understand that we have some very important issues going on today but if you have a story involving: 1. The FDA 2. The Supreme Court 3. Congress 4. Both political parties (What has Bush done? What will Obama do?) 5. Our civil liberties (a day in court) 6. Big business (pharma - one of the biggest in the world) 7. Corrupt FDA Management 8. FDA Whistle blowers 9. Public Health (You and I) what would you think if there wasn’t a word said about this issue in prime time major media? Would you think that maybe it might have to do with advertising income? I don’t know, I’m just wondering.
If you were to ask 100 Americans today to tell you what FDA Preemption means what percentage would be able to tell you? I would guess maybe one in one hundred. Is it OK for this issue to go unreported and unnoticed by the American public when it could be the biggest public health story of our time? I am interested in your thoughts about this. Thanks
Of course, there is already a a petition that has been reported upon here. That has been very valuable for the comments, above all, and for providing people with at least one thing they can do.
Media reports when there is "news" - which means, usually, the day before and after a case like Levine. When the Court decides Levine, we can be sure there will also be a "major story" or two.
Meanwhile, there are specific Senate and House bills that would have the effect of reversing Riegel. There is no reason (and probably no good reason) to expect anything on these before the new Congress is seated.
Justice or Jaynesday, I guess I'm dense, but can you explain the link to preemption here? All I see is some corrupt individuals at the FDA who were identified. Note that this was found out without a lawsuit. I really don’t see the link to preemption: 1) Are you suggesting that lawsuits against a device manufacturer would have prevented this corruption? 2)Or are you suggesting that the proper retribution in a case like this is to hold a company liable for corruption at the FDA? That hardly seems fair. It says to me that, at least superficially, the system is able to root out corruption in the ABSENSE of lawsuits. (That’s what happened here, right?)
Nathan, In my mind it shines the light on two aspects of the FDA structure or proposed structure. Item one would be FDA preemption which requires that we have a "gold standard" organization that is the "last word" on our drug and device safety. This absolutely must be the case for preemption to work. As you know we have been saying that the FDA is not capable to carry this out for months. The counter structure to this, now standing side by side with preemption is FDA Management Corruption which is absolutely counter to a gold standard for safety. This news article further supports what we have heard from a number of others, not just our Pharmalot FDA friends but reports from others. I presume that you feel that now that the story is out the FDA is fix? I don't. I think we have to understand how and why it became what it is and then begin a basic structural change that will divorce it from industry influence. I can't even begin to imagine what it will take to accomplish this.
But until it's done we need to shelf preemption.
Misfit,
I think you missed that this is about FDA's Devices group and not pharmaceutical companies. I am still wondering how people are calling for the device and drug manufacturers to be arrested, when it is the agency that is having the issues.
Compliance Analyst,
This is a systemic problem across FDA and doesn't just effect devices.
It's just that the reviewers in devices were able to organize and put something out en masse. I would guess they are a smaller group with many more long timers than CDER. All power to them.
In CDER we tried to do the same thing only with all the shuffling around of reviewers and the absolute fear we could never able to get and maintain a critical mass.
An FDA Reviewer
Again...I was commenting on the person that is saying that "the pharmaceutical companies", (not the FDA) should be hauled away and put in jail. The upper management in the FDA is just as responsible.
I understand that pharmaceutical companies are in the crosshairs of many people, but making a comment about jailing people in the pharma industry on a post about CDRH corruption is totally unrelated and asinine.
Sometimes I wonder if what we write in these blogs is read by those at the FDA, the executives of pharmaceutical companies or others. I wonder if they consider the thoughts and concerns we struggle with here. We know that some do. I personally thank those in the FDA that are concerned enough for our safety that they risk their own well being to protect it. It is a immense responsibility and it touches the lives of so many people
To them I give a big Thank-you!
Without them we would certainly be at the mercy of some who have a disregard and apparent contempt for the American public; the same people who pay their salaries and have put their trust in them to protect their children, parents, spouses, friends and themselves. They have decided instead to look after their own best interests. I am saddened that these kinds of people have attained this level of trust in *our* FDA.
A quote from the FDA Staff letter to Congress says it all. This quote is from the November 2007 FDA Science Board Report found on the FDA’s own site under Dockets. The study title is - FDA Science and Mission at Risk. It says:
"A strong Food and Drug Administration (FDA) is crucial for the health of our country. The benefits of a robust, progressive Agency are enormous; the risks of a debilitated, under-performing organization are incalculable. The FDA constitutes a critical component of our nation's healthcare delivery and public health system. The FDA, as much as any public or private sector institution in this country, touches the lives, health and wellbeing of all Americans and is integral to the nation's economy and its security. The FDA's responsibilities for protecting the health of Americans are far-reaching. ... The FDA is also central to the economic health of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually. The industries that FDA regulates are among the most successful and innovative in our society, and are among the few that contribute to a positive balance of trade with other countries. The importance of the FDA in the nation's security is similarly profound. ... Thus, the nation is at risk if FDA science is at risk."
I imagine that this paragraph was an inspiration for the good people at the FDA. For the others it was ignored.
Compliance Analyst,
The connection is money. The FDA is in the pockets of Big Pharma. I don't differentiate between the pharmaceutical industry and medical device industry - Big Pharma companies like J&J, Abbott, Baxter and Pfizer operate in both sectors.
A revolving door exists between Big Pharma and the FDA. Big Pharma lobbies to get individuals with strong connection to the pharmaceutical industry appointed to high level positions within the FDA. Career employees at the FDA who do the bidding of Big Pharma have high paying jobs waiting for them in the pharmaceutical industry.
A good analogy to the criminal alliance between Big Pharma and the FDA is the criminal alliance between the Mafia and Labor Unions. Historically the mafia controlled labor unions. The mafia decided who to place in top union positions. It was the mafia that named union presidents like Jimmy Hoffa, Roy Washington, Jackie Presser and Ed Hanley. These guys were all paid off by the mob and did the bidding of the mob.
In the same way labor unions were beholden to the Mafia, the FDA is beholden to the PharMafia.
The PharMafia though, is much more dangerous than the Mafia. There was widespread support of law enforcement efforts to fight mafia infiltration into legitimate businesses and politics. The PharMafia has completely infiltrated legitimate businesses and politics, but citizens do not understand the extent of the corruption of this criminal enterprise.
The Mafia makes payoffs to business executives and politicians in the form of cash payments and ghost-jobs. The PharMafia makes payoffs to business executives and politicians in the form of campaign contributions, grants, and honorariums.
The Mafia makes targeted hits on members and business associates who understand the risks of dealing with the mob. The PharMafia, by hiding data that shows dangerous adverse events for their drugs, targets innocent consumers who are ignorant to the risks associated with the drugs they take. The mafia kills a handful to dozens of people each year. The PharMafia kills hundreds to thousands of people each year.
The FBI has had success in fighting mob infiltration into legitimate businesses through massive under-cover operations that have resulted in hundreds of felony convictions of corrupts businessmen, lawyers, judges, and politicians. Only by carrying out similar under-cover operations within the PharMafia will some of the thousands of made members of the PharMafia be brought to justice.
Ima Misfit,
Well said. the truth... but people can't accept the facts yet(denial), as it is white collar crime taken to the very extremes.
If you look at the documents you will notice that severe retaliation took place after the reviewers spoke complined to Dr. Von Eschenbach and he had them speak to William McConagha the Associate Commissioner for Integrity and Accountability.
Mr. McConagha is a lawyer who Dr. Von Eschenbach promoted to this position right after Congress had the agreement that FDA's Office of Internal Affairs (OIA) investigate criminal compliaints against FDAers instead of the Office of the Inspector General (OIG). This was a conflict of interest as OIA reported to the FDA Commissioner and it had been documented that on multiple occassions that they had started criminal investigations against FDA whistleblowers (Andy Mosholder - Antidepressant suicidality) and suspected whistleblowers (Leo Lutwak - Diabetes Drugs). Plus it was uniques throughout the entire government.
Part of Mr. McConagha's job is to act as Dr. Von Eschenbach' legal counsel regarding any criminal investigations by OIG.
Reviewers in CDER who have complained to Dr. Von Eschenbach about criminal activities within CDER with respect to drug reviews and approvals have also been directed to speak to Mr. McConagha only to be subsequently severely retaliated against.
Just out of curiosity, who does Pfizer own in the medical device arena?
I understand putting J&J and Abbott on the list as they are tops on both sides, but Baxter doesn't even crack into the top 20 pharmaceutical companies. I know our company discontinued our medical device because trying to play by two different rules is not worth the time and regulatory risk.
As someone who has direct interaction with the FDA when they come to inspect our site, I can say that they are not coming in as old friends and being buddy buddy with our management. The field inspectors are coming in to collect evidence every single time they come into our facility. We never hide anything from them and will never do so.
You can take your "mafia" reference to almost every single industry, since most industries give money to politicians.....it is called lobbying. The FDA needs to do their own cleaning and if you can find a "link" between pharmaceutical companies and those in power at the FDA, then you can start "marching them in handcuffs" down the middle of the street and charge them under RICO.
Compliance Analyst,
Regarding RICO I hope it will only be a matter of time.
We need to wait until we have a new attorney general who's not under Bush and then see if Obama allows the DOJ/AG to do anything or not.
I really hope they do something if there truly is a problem. I think companies that are bribing or caught doing some sort of malfeasance should be held accountable.
If people in my own company were involved in malfeasance, I would help kick them out the door. Remember that people in the industry have families, friends, etc. that are taking these medications. I do what I do (regulatory compliance) because I want to ensure that my company is doing the right things.
Compliance Analyst,
I mentioned J&J, Baxter, Abbott, and Pfizer because they all have internal groups that operate as powerful GPOs. While Baxter isn't nearly a stong as it once was, they along with J&J were among the first GPOs. In fact J&J's GPO - Health Care Systems (HCS) met with the other pioneering GPOs in the 1970s to implement a plan of action to inhibit price competition.
These groups have very affectively implemented policies and succesfully lobbied for legislation favorable to their oligopoly.
By bundling products from all OpCos; pharma, MDD, wound-care, diabetes care, institutional products etc... these Pharma/MDD/Consumer/GPO companies are able to charge higher prices for products that are inferior to their smaller competitors.
You own a small company that makes a hemostat that's better than any of your competitor's hemostats, and it's half the price of the competitors? Too bad.
If a hospital buys your better hemostat, the big pharma company that currently supplies their hemostats will no longer give them a 50% discount on the $100 million in pharmaceuticals they buy each year. The hospital will continue to buy the expensive shitty hemostat in order to get a discount on pharmaceuticals.
I am still curious as to who Pfizer's group GPO is...just for my own knowledge, I know they sold off their OTC division (to J&J).
I work mainly in the manufacturing world, and maybe don't know everything about the distribution side of things, but aren't most hospitals, pharmacies, and the like buying from a distributor? And even if they are buying directly from the manufacturer, what is wrong with offering a discount for buying in bulk? We see that every day in retail and other industries and commodities. Buy 10 get 1 free, BOGO deals, the more you buy = the less it costs, etc.
The thing is for almost any drug there is an equivalent from another company, there is another medical device from a different company....the hospital just wants to make profits....no shame on them?
The FDA has beaten up for the past four years because it has helped the Democrats gain points with the public. Now that Democrats are appointing staff heads at the FDA, CMS, etc., I'm just wondering whether politicians will continue to give the aforementioned appointed officials a hard time.
The FDA is not a partisan issue. Senator Grassley the ranking REPUBLICAN on the senate finance committee has been trying to hold the FDA accountable for years and is one of the FDA's most vocal critics. Much more so than any Democrat.
It's the party in the majority who controls the oversight committees that is able to hold any government agency accountable. The Republicans lost the senate in 2006, it was only then that the Democrats began to act aggressively to demand oversight. Even so Senator Grassley has continued to bring light onto the goings on at FDA. Senator Grassley supported Senator McCain and it is because of this that I suspect that they might have come to an agreement about cleaning up FDA. Senator Grassley was also clearly was working in a bipartisan manner with Senator Baucus to clean up the FDA. I hope that the next administration and congress both continue to work together to clean up the FDA.
The health and safety of the American public is not a partisan issue and even though I am registered as a Democrat I have found that many Republicans of varying stripes in the present administration are disgusted with what has occurred. FDA corruption is a real issue and is not a matter of partisan politics. Individuals of every political persuasian are working to correct the problems. In fact most of the whistleblowers I know are true conservatives, whether democrats or republicans. Many of us believe in conserving the constitution. Many of us believe in fiscal responsibility. Many of us believe in accountability and old fashioned ethics and civic responsibility.
I respect anyone based on their actions and not by what they claim or any political label they wear.
If President Elect Obama appoints people to these positions who act appropriately then I expect we won't need to see the same level of whistleblowing and oversight that we have seen under the Bush appointees. Time will tell.
On reflection, CDRH may be right that it's worse in medical devices. After all at least drugs have to be shown to be effective, devices don't.
Just now seeing Nathan's post above.
Shortly after the Riegel decision, the Drug and Device Law blog -- which has become the "voice" of preemption within the world of coroporate defense lawyers - posted, in part, this on the implications of preemption that the decision now afforded the device industry.
"The FDA will have to display, day in and day out, the “rigor” that the Riegel majority found in its approval and post-approval processes. If the Agency doesn’t provide strong regulatory oversight, then inevitably unsafe medical devices will enter the market and people – real flesh and blood people – are going to get hurt. So we expect the FDA to reject such devices, even though in specific instances this will cost companies a lot of money. We expect the FDA to come down like a ton of bricks on anybody who cheats on safety-related issues after approval, such as not reporting adverse incidents, or not following good manufacturing practices."
We will have to wait and see how systemic and deep was FDA's senior management alleged suppression/intimidation of its own scientists. The suggestion is that it was not a few "zealots" but representatives of agency policy at high level.
that turns out to be the case, the 'rigor' and 'strong regulatory oversight' that DDL references will turn out to be a house of cards, indeed. And, as a result of preemption, 'people - real flesh and blood people - are going to get hurt.'
Preemption is premised on the description of FDA that begins DDL's paragraph. That is what is own most vocal defenders tell us.
This in response to FDAer's post. I could not agree more. It is extraordinary that some number of "social conservatives" find themselves struggling to defend policies and practices that could not be further from "old fashioned ethics and civic responsibility."
Yet, as you suggest, there appear to be fewer and fewer. The chorus of disgust is growing, from all parties, and from all citizens.
Further thought to Nathan's thought. It may well be true that, to the extent preemption succeeds (as it has with devices), the more likely reviewers of conscience will risk being whistleblowers. At the same time, based on the report we've received here, the more tactics will appear to intimidate or eradicate those who do not tow the line.
So one would expect a flurry of protests, followed by retaliation, repression of the "troublemakers," and overall denial - more or less what is described by Dingell/Stupak in their summary of these events, which FDA itself had buried.
Ed, Maybe you could give us your opinion here. My question is why has this story not been picked up by the major media? Not to say that Pharmalot is not major, but I would have expected more coverage overall by the media on this subject. I understand if you might not want to interject your own opinion here but if not please do. Thanks
Hi Jaynesday,
Happy to oblige. First, The Wall Street Journal and The Minneapolis Star-Tribune both ran stories - The WSJ this morning and the Minneapolis paper late last night, as far as I can tell. Dow Jones actually was first to report this and did so yesterday. Bloomberg News also ran something yesterday, but the headline and lead sentence referred to earnings and litigation costs, while the DoJ investigation was secondary.
That said, there are a couple of factors at work. For one, unless a journalist has followed the story, the implications of this particular revelation may not be clear, even though the device was placed in 'x' number of people. The context may have been lacking yesterday. Why do I say that? The disclosure was not widely disseminated by the company - it was first mentioned in a conference call with analysts - and, therefore, was easily missed. I only knew because Dow Jones, which I cited in my post, pays regular attention to that sort of thing. So health editors and writers may not have been alerted.
Moreover, the mainstream media is shrinking - there are, literally, fewer journalists working in major newspapers and magazines now than at any time in the recent past. This means coverage of certain topics is actually handled either by overworked people or the base gets covered by using 'wire' stories from the Associated Press, Reuters, Dow Jones or Bloomberg. The Washington Post uses HealthDay News as well, to cite another example. Pick up any major paper and study it carefully over the course of a month and you'll see what I mean.
And so this particular story fell through the cracks. But those cracks are forever widening. Will web sites fill the void? Eventually, some will. That depends on business models validating their existence and, of course, which of those devote themselves to tracking such developments, for whatever economic reasons. We have entered what is going to be a very long transition period for mass media, as we think of it, and it will look very different whenever this evolution is completed.
In the meantime, some stories will not get the attention we have been trained to expect. Now, though, I will return to work, since my little diatribe is a bit off topic. Still, I hope this was helpful. It's a fascinating topic - one that puzzles, fascinates, concerns and motivates me every day.
Cheers ed
Great explanation, Ed. Thanks. Gardiner Harris did a short NYT piece yesterday too (sorry if I missed your mentioning it), but without much context, just as you suggest.
Ed, Sorry I didn't see the story on the Congressional probe anywhere but here. Good Job!
To Anon on Nov 18 at 11:13 am--
Very interesting about Mr. McConagha. Can you please provide more details? I think other persons at FDA need to know more about this. Thanks
Lawyer for Justice.
I can contact the Congressional Committee who released the letter about retaliation against the CDRH reviewers. Will this be useful?
Isn't this a funny environment we live in? The blogosphere allows voices from nowhere to be heard by many (I include myself of course). Names, backgrounds, motives and beliefs can be hidden or invented at will. Just a crazy thought. I'll go back to my real life now.
That would be very useful.
Anon, Why are you surprise about retaliation? Have you read about all the whistle blower cases? Especially against giant Novartis? All that happens is aggressive, well coordinated retaliation. Numerous legal complaints from Class actions, regional director, global director,...{sexual harassment, fraud in clinical trials, whistle blowers etc.). Novartis is now a den of monster bullies with employees are kept under mute surveillance. You complain, you are out, and followed around by the Swiss Mafias!
FDA stings when it comes to ethics. The system is fractured and obsolete. They conduct meaningless audits and refuse to publish the reports. "User fees" speak louder than science and ethics. Hopefully, and soon Obama team will rescue the masses.
They publish the audit reports....you just have to pay for them.
this is nothing new, the FDA does a lot of good things but more and more people have been dying w/ their so called Approved pharmaceuticals. We need to step up and use Natural products as mother nature knows what our bodies need. That's why not a single being has died using natural remedies. Did you know that The FDA will fire any medical doctor (MD) for using or recommending any natural product unless it's for a side effect from a pharma product? That's because if the people realized that they just should have used the natural product in the first place instead of the synthetic patented formula by the FDA, their multi-billion dollar profit would disappear. Not a single company or person can patent anything completely created by mother nature. It's like patenting an orange and taking all profits and rights, it's not possible thru the USPTO.GOV where companies register their products. The Green-Era'z Comin' thru anyways so keep fuckin' up FDA and proving our natural points.
All of you at FDA who care about the safety and effectiveness of drugs, devices and biologics PLEASE continue to speak out. Never let any product out to market that you DO NOT believe is safe or effective.
As the person who writes and submits PMAs and 510(k)s to CDRH and CBER, ask me lots of questions. If you DO NOT believe that the data shows to you that the product I am submitting is neither safe and/or effective, do not let me release the product to market!
Correspondence between POGO and the Center for Devices and Radiological Health (CDRH) of the FDA
October 9, 2008
POGO is examining a long-standing regulation, the Good Laboratory Practice (GLP) regulation, 21 CFR Part 58, which is meant to ensure the safety of medical devices. Specifically, POGO is examining the apparent failure of a large subdivision of the FDA – the Center for Devices and Radiological Health (CDRH) – to enforce the regulation. POGO is preparing a report on the findings of this examination.
On April 30, 2008, POGO wrote CDRH Director Daniel Schultz asking a series of questions about the apparent decision not to enforce the GLP regulation. On May 13, 2008 POGO sent him a follow-up letter, and on May 27, 2008 POGO received a reply from the Associate Director of a unit within CDRH.
Founded in 1981, the Project On Government Oversight (POGO) is an independent nonprofit that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open, and honest federal government.
# # #
Of concern is that in one of the blacked-out portions of the letter it seems that the words "cosmetic lasers" would fit perfectly. HUGE industry for $$$$$ while knowingly exposing people to dangerous radio frequency.
I'm looking for an "un" blacked out copy of this letter. Will that ever become available?