Back in 2008, private eyes working for Amphastar Pharmaceuticals gathered info about Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research, collecting details about her husband, two daughters, and in-laws, and retracing her steps on a business trip she took to Thailand, writesPolitico, which essentially rehashes and fleshes out a juicy piece in The Wall Street Journal last fall ( see here).
Amphastar paid more than $100,000 to Kroll for the low down. At one point, the investigators hired a freelance reporter to file Freedom of Information Act requests, using her status as a journalist to request Woodcock’s emails, phone records, voicemails, calendar and expense reports, among other documents – without mentioning that she was being paid for her efforts by a private investigative firm. (OUR TWO CENTS: Really? That's not kosher).
Why the fuss? Amphastar worried the FDA wouldn't allow it to market a generic version of the Heparin blood thinner, a market worth more than $3 billion. So Ahphastar turned to Kroll after becoming frustrated the FDA was delaying. The company also worried the FDA was favoring a competitor, Momenta Pharmaceuticals, and suspected Woodcock was somehow allied with Momenta, Politico writes. However, we should note the FDA legal counsel recently declared there was no conflict (look here).
Kroll also investigated Moheb Nasr, director of the FDA’s Office of New Drug Quality Assessment, creating a file included the price he paid for his home, and details of his education and professional background. Amphastar says the investigation was done in order to find out if Woodcock or Nasr were unfairly favoring a competitor in the drug approval process, and that it did nothing wrong.
“I feel like as a citizen you have a right to question your government and a right to look a at public information. There was no impropriety here,” Amphastar general counsel Jason Shandell tells Politico, adding that the investigation was limited to public records, database searches and other information available to the general public.
The case has greatly interested the Senate Finance Committee, whose chairman Max Baucus calls this “an outrage,” and demanded Kroll tell him how often private detectives target public officials. “Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families,” he tells Politico.
14 Comments
So, just a few flags on the play here...
1.) What if something came up with the husband, two daughters or in-laws?
2.) What if during the trip to Thailand, Ms. Woodcock gave herself some umm"personal time"? - whatever...
3.) What was the intention of the investigation, how would the information be used?
I am hearing whispers of the the word blackmail in here, anyone else?
Maybe now that we know about this, others will come forward.
This was inappropriate, the minute you hired a reporter to pose as something she wasn't to invoke freedom of information there is a problem.
Then of course this raises the issues of you cannot trust others, if you yourself feel you cannot be trusted - no?
Well my Dear Dr. Woodcock, welcome to the club!!! Im sure it made her feel loved.
These detectives, just dont look for public information, but extremely private information. Senator Baucus should request a copy of the Investigatros' notes. Darn, I forgot, the company will argue that the notes are, a work product, of the Company's attorney.
Shame, Shame, on the reporter.
Lisa,
Actually I would be willing to bet Senator Baucus has the company's investigators notes. Along with many other senators which explains how they got into Politico's hands. But I find Baucus's comments laughable considering the drug has been sitting at the FDA for several years long since the patent has expired. Why isn't Baucus worried about all the needless dollars spent because a generic has yet to be approved for Lovenox???!! (Long after the patent has expired). Ed cites a $3 billion dollar figure - wouldn't some of those resources be better used on other things if there was generic savings?
Some facts. Amphastar is not some huge drug company. They are a mid-size to small US generic manufacturer. They filed their petition in 2003 and achieved FDA's prerequisites for approval back in 2007. All of a sudden, Woodcock stepped in and began favoring Amphastar's competitor, which is sponsored by big pharma (foreign icons) Aventis (French) and Sandoz (Swiss), and Amphastar's approval ground to a halt while Woodcock cavorted around the world with Momenta executives. Amphastar has paid a fortune in taxes year after year, employing Americans in CA and MA. Momenta is a shell company of big pharma, on whose pockets Janet Woodcock has been for years. This story is incredibly unfair, because the real issue is what manner of lying and deceit from FDA finally drove Amphastar to hire help to find out what was going on while they waited and waited. If you people who are attacking their actions knew the real story, you might take some pause and realize that this story is being manipulated by the same liars and crooks who have been trying to keep prescription costs high and kill health care. I hope Amphastar gets their approval. There are three companies applying for this drug, and they filed first, proved their case and happen to be the only one that is American.
More interesting is the fact that Baucus and Grassley are the Chairman and ranking member of the Senate committee investigating Kroll and Amphstar. Mark Hayes of Grassley's staff is married to a woman named Katherine Hayes, who is a lobbyist for Momenta, the Aventis/Sandoz shell outfit that Amphastar believes is working with Woodcock to hold up their approval. Another Grassley staffer is sending this story all over town, trying to generate interest. Someone needs to investigate these people--Woodcock, Momenta, Sandoz, Aventis, Hayes, maybe even Grassley and Baucus, who never wanted single payer because he is a wholly-owned subsidiary of the insurance industry. Baucus's quote is precious: he tells Amphastar to focus on their science and stop investigating innocent government officials. Amphastar did focus on its science, and got screwed. Why should anyone blame them for doing what any investigative reporter does every day.
This was a fascinating story, but not the one Javers intended. The real story is how people like Woodcock, Baucus, Grassley, the Hayes's and others scratch each other's backs at the expense of consumers. I'm sorry, but those of you defending Woodcock need to do some homework. Start with Alicia Mundy's book: Dispensing With the Truth. You'll never look at FDA the same way again.
Finally, this is old news. Mundy published this same story many months ago. It is recycled stuff, probably leaked at Momenta's urging (since a Grassley staffer is married to one of Momenta's lobbyists). Woodcock should be in jail not approving drugs.
"Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science"
Boy, have they got a lot to learn about this industry
I think I'll stick with believing the version of the story posted above by Anonymous 7581l. I remember reading tidbits about this tale and the whole thing blowing up like this does not make any sense. Woodcock the Saint - yea right.
Like the big drug companies haven't stooped to much more devious plots than this to destroy a competitor or a whistleblower or a plaintiff in a lawsuit.
Baucus acting all alarmed is absolutely laughable, why doesn't he go after the real thugs.
Based on the story given to us by Anonymous 7581, I would change my stance.
But clearly this shows us all something.
Not all cases are about the science, it is about people abusing their power and playing favorites...
Big Pharma abuses their mandate and so does the FDA. One of them has to get cleaned up, it has to be the FDA because they are only given their power through the people, citizens they represent. How can they "pretend" to function in the best interest of the people and examine and approve drugs and devices when in fact they are not. Penalties and fines should be given to any person at the FDA caught usurping their position in government. No second chances either, once you've been caught, your integrity is destroyed...look for work elsewhere.
if that's true, Anon 7851, then why didn't Kroll find any evidence of wrongdoing? you say that someone needs to investigate these people, but some of them have been investigated. and Ed mentions Alicia Mundy's article in the first paragraph.
Kroll was probably looking for $$$. No more details here but I already gave Doctors Sharfstein and Hamburg what I know about what went on. They chose to do nothing. That is the way it has been for years inside FDA. Saint Janet is untouchable but the truth is going to come out sooner or later but more likely later. A lot of us thought Obama was going to encourage whistle blowers but nothing has changed here at all. Same old same old.
But then again, two wrongs do not make a right...
As a result of these stories and allegations FDA's Office of Chief Counsel conducted an "investigation." In a public statement, FDA's lawyer noted that there was no impropriety on the part of Dr. Woodcock because she had no financial interest in any of the involved parties. Nonetheless, she had "graciously agreed to step aside," and not be involved in the enoxaparin approval process in the future.
In fact, she has continued to direct the process behind the scenes, although it's hardly a process. After ensuring that the Office of Compliance had built a case sufficiently strong to prevent an Amphastar approval anytime soon, Momenta's application was moved forward and readied for approval. However, all the publicity associated with the allegations of favoritism caused great consternation on the lawyers part and serious backfilling began with meeting after meeting, the sole focus of which was to speculate about "appearances." This led to increased inspectional scrutiny, essentially designed to repeat the treatment accorded to Amphastar, even though, as with Amphastar at one point, the inspectors had signed off already. During this process it became clear to me and others that the 'inspections' and interpretation of the results were simply used as justification for whatever regulatory path Dr. Woodcock wished to follow.
As time goes by, it seems less and less likely that the American consusmer will benefit anytime soon from the increased availability of enoxaparin. This much safer anticoagulant alternative to heparin will continue to line the coffers of pharma giant Aventis, to the tune of $3+ billion per year.
What astounds me and others involved in this process is that nobody seems upset by the obvious conflict of interest for Woodcock, Nasr, et. al. Irrespective of financial interest, it is unbelievable to me that our Commissioner/Deputy Commissioner, Congress, and others have not reacted at all to the public information documenting meetings, trips, and scientific collaboration with Momenta officials.
Welcome CDER Employee.
Of course it's the same old stuff that they always do.
I hope DOJ has an extra special place for the FDA lawyers for after the S hits the fan.
ex-FDAer
janet woodcock attended a meeting with momenta pharmaceuticals in february of this year. apparently woodcock enjoys cavorting with selected industry at these meetings. this is a conflict of interest. patients do not have the same access to ms woodcock. she also had a phone call with eschenbach on fda time and phone. see FDA calendar.
Please. This is nothing. You wouldn't believe the meetings Janet has had on Wall St. and with whom.