Waxman To Eschenbach: Whose Side Are You On?
12 CommentsBy Ed Silverman // September 17th, 2008 // 1:16 pm
Henry Waxman continues to have his suspicions about the FDA. In a letter today to FDA Commish Andy von Eschenbach (pictured to the left) after receiving internal FDA e-mails about agency decisions over the couple of years. His conclusion? “Political appointees at the agency may be promoting industry priorities at the expense of FDA’s core public health mission,” according to Waxman.
For instance, there was an e-mail dated June 15, 2007 from Sheldon Bradshaw, who was then FDA chief counsel to Scott Danzis, who was then Bradshaw’s special assistant. Bradshaw asks Danzis to provide a list of “the guidances/regulations you are working on or would like to work on.” Bradshaw goes on to write: “I’ll send that list to the Deputy Secretary who, in turn, will send it back to the FDA as his list of priority projects. That will ensure that our projects are moved in a timely fashion.”
And what are the priorities?
1 - Proposed rule to amend regulations permitting companies to update drug and device labels with new safety information;
2 - Guidance document on the distribution of journal articles;
3 - Guidance document on off-label promotion and manufacturer dissemination of off-label information;
4 - Guidance document on intended use with respect to drug and cosmetic claims;
5 - Proposed amendment to FDA regulations interpreting express preemption clause in FDCA for medical devices;
6 - Final guidance on: “Help-seeking” and Other Disease Awareness Communications by or on Behalf of drug and device Firms;
7 - Final guidance on: “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements;
8 - Final guidance on: “Consumer-Directed Broadcast Advertising of Restricted Devices.”
“Whether coincidental or not, the list that Mr. Danzis provided to Mr. Bradshaw contains several initiatives that are known to be long-sought goals of the drug and device industries. All appear to prioritize industry desires over consumer protection by reducing FDA regulation of industry marketing practices, eliminating industry liability for injuries caused by their products, and by making it easier for drug and device companies to advertise their products directly to consumers,” Waxman writes.
“There are many questions raised by this e-mail. The process for setting priorities described in the e-mails appears designed to bypass normal channels. Moreover, there is a major disconnect between the priorities identified by Mr. Danzis and the issues that public health experts have said should be FDA’s top priorities. Mr. Danzis’s list - and FDA’s subsequent actions - put initiatives that benefit the pharmaceutical industry at the top of FDA’s priority list.
“By contrast, your own FDA Science Board identified a very different set of issues in dire need of attention. The Science Board concluded in November 2007 that “American lives are at risk” because limitations in resources leave the agency unable to attend to a frightening number of critical regulatory and public health responsibilities.
Just A Thought
Can we add that a post marketing commitment be required for every new, copy cat, or reformulated product put to the public?
And for the manufacturers to not be allowed to enter into collaborations (CRADAs) with their regulators?
For MedWatch to take all instances of AEs equally seriously, anticipated or not?
How about if anyone defects from the FDA to work in the pharmaceutical industry to not be allowed rehiring by the agency?
To ditch any statute of limitations where it can be reasonably proven that delaying, denying, or suppression of information has taken place?
Jim
von Echenbach is in bed with big Pharma and the medical device companies. I know they do not look at their maude reporting system, if they did they would see that there are over 3000 adverse events filed for hernia mesh and polypropylene mesh in general. They know these products are having severe post market complications as stated by the letters I have recieved from Dr. Frank Torti, Dr. Daniel Schultz. Yet they do nothing for fear that the medical device companies will stop financing the FDA. If you want to read horror stories all one has to do is read what was reported to the FDA thru their own adverse reporting system on Hernia meshes, Bladder suspension slings or just polypropylene meshes in general. These products can disable even the healthiest person. There are many more in the FDA that know of the severe post market complications and are tied down by von Eschenbah and not allowed to protect the public.
Justice in MI
For those of us following the apparent “game plan,” and suggesting the connections between various FDA initiatives, the list is pretty connects those dots.
Ima Misfit
We know which side von Eschenbach is on; the same side as all those who came before him.
The corruption that is systemic to United States government agencies like FDA, MMA, OSHA, State Department, FAA, CMS, DOD, etc.. cannot be corrected by the handful of good senators and the dozen or so good representatives who can no longer rely on the disgraced Justice Department to enforce the law.
Justice in MI
There have been some strong, no bs FDA Commissioners - especially Goddard in the 60s. Kessler was mixed, but certainly relative to who’s been there since…
Salmon
Von Eschenbach said
‘direct-to-consumer advertising is a First Amendment right’
‘He won’t tolerate whistleblowers who go outside the agency just because they don’t agree with an outcome.’
“The people have to understand to go outside that process is not constructive. It is actually destructive.”
New Jersey Star Ledger
Thursday February 22, 2007
harpy
Wow. Every so often I start thinking it’s all conspiracy theory, then I see something like this.
Anyone see any apologists around? They’re always so scarce on these posts.
Justice in MI
Harpy - One person’s conspiracy is someone else’s game plan. The agenda has been around for some time, but the current administration allowed full regulatory capture.
I think apologists are too busy digesting the henhouse, but maybe someone will come out to burp and say a few words.
truthman30
Wake up America..
The FDA and Pharma are two sides of the same coin..
Its the same with the MHRA in the UK..
Hen House
Before I’m gone, I’d just like to say
American4Science
On sure fire way to make sure that political appointees have the same values as we do is to get someone who shares our ideals about how the FDA should be run and regulated in office and appointing people. This election gives us a good opportunity to decide who will choose the next appointees. Both McCain and Obama have responded to question 10 of the Your Candidates - Your Health questionnaire which talks about the funding priorities for FDA. Hopefully we can be proactive in getting the people we want making the decisions we need.
jooe
The one person from JNJ who stood up and tried to get the Ortho Evra Patch withdrawn from the market was fired. Many of us women have had strokes, heart attacks and blood clots, all because of JNJ and the FDA.
Pharmaceutical Whistleblower
Former Johnson & Johnson Chief Medical Examiner Dr. Joel Lippman recently blew the whistle on his old company. Lippman claims that during 15 years in high-ranking medical positions at Johnson & Johnson, the company repeatedly released or refused to recall dangerous products to which he objected, including the Ortho Evra birth control patch. In a whistleblower suit brought against his former employer, Lippman claimed, “The clinical research had revealed that the estrogen dose released by the Evra patch as a means of birth control may increase the risk of deep venous thrombosis and pulmonary embolisms.”