The Journal on page one today shines a bright light on some shady doings at the FDA, finding that Democratic politicians, doing a corporation’s bidding, put pressure on administrators to approve a medical device, causing corners to be cut, lies to be told, and the product to be approved on a fast track.
This is the kind of work we love to see, even though, as a commenter on the Journal’s site says about the headline “Political Lobbying Drove FDA Process”:
“This headline is akin to “Sun Rises in East”.
Granted (I discuss WSJ heds down below, for all you copy editors out there), but it’s essential to get a look inside the sausage factory every once in a while.
The Journal describes a process in this case that’s, well, corrupt. I don’t know what else you’d call it. It even has a smoking gun:
In November, agency officials drafted a letter to ReGen saying the FDA had taken into account the company’s “criteria” for the “structure and composition” of the panel, according to emails reviewed by the Journal.
The FDA’s acting chief counsel warned against that language, saying it would “document special treatment for ReGen.” Another FDA lawyer said the wording would “cause significant problems for the agency” because other companies don’t have the same “opportunity.”
The director of the FDA’s integrity office replied, “I’ll excise the language.”
The final letter didn’t include the language.
There you go. It’s so obvious that reporter Alicia Mundy even pulled a mea culpa out of somebody responsible:
“There’s something wrong with how that decision [to go the fast-track route] was made,” said Andrew von Eschenbach, who was head of the FDA in December, when Menaflex got the go-ahead. “We fumbled that process.”
Hey, you’ve got to give the guy some credit for owning up to it. How many other Washington (or Wall Street) creatures have done that?
Here’s some background on what happened. The FDA, apparently correctly, declined to let ReGen’s knee-implant product go in for fast-track approval. After the second time, a bunch of Democrats in Congress from New Jersey, where ReGen is based, went to see the FDA chief. Two days later, the FDA chief handed the request to an underling, who took a shortcut through the normal approval process, let ReGen influence who got on the approval panel, distorted what the panel said, and approved it.
The FDA’s regular committee process was circumvented, says Dr. Mabrey, the Baylor surgeon and committee chair, because members were given only six days to review hundreds of pages of documents instead of the usual several weeks.
When Dr. Schultz summed up the meeting in a letter afterward, he said the committee “clearly and unanimously” found Menaflex to be at least as effective as other surgical meshes on the market.
A majority of the eight committee members, including Dr. Mabrey, said in interviews that Dr. Schultz was wrong in saying the members were unanimous. “I made a point of noting that we were not unanimous,” Dr. Mabrey says. “The important thing is that we didn’t say the device was substantially equivalent to other devices.” In addition to Dr. Mabrey, at least two committee members expressed reservations. Dr. Mabrey says if he had known Dr. Schultz was going to approve the device citing the panel, he would have strongly spoken out against it.
Good work by the Journal.
Although as a side note: It’s sad to see that the paper’s signature leders, like this piece, are relegated to below-the-fold status under the Murdoch regime. This seems to pretty much be a permanent change.
And you’re not going to sell papers with giant fonts that result in five-word headlines like this one. The old Journal triparte headlines drew readers in. These push them away.
Fortunately, the “aheds” still have them, like this one from a couple of weeks ago:
A Florida Court’s ‘Rocket Docket’ Blasts Through Foreclosure Cases
2 Questions, 15 Seconds, 45 Days to Get Out; ‘What’s to Talk About?’ Says a Judge
Sure sounds a lot more interesting than “Political Lobbying Drove FDA Process.” Zzzz.