Journalists To FDA: Take Off Those Muzzles
11 CommentsBy Ed Silverman // December 2nd, 2009 // 12:30 pm
Eleven major journalism organizations want the FDA to end requirements that journalists and FDA employees notify or obtain permission from an agency official in order to talk to one another. They argue the restrictions prevent journalists from gathering as much info and insight as possible, because agency employees may be inhibited or barred from providing important details and data.
And so several groups, including the Association of Health Care Journalists, the Society of Professional Journalists, the National Newspaper Association, and the Radio Television Digital News Association, among others, have sent a letter to the FDA’s Transparency Task Force. The journalists, by the way, also object to public information officers listening in on interviews.
“These restrictions have become increasingly widespread in federal agencies and other organizations,” Charlie Ornstein, president of the Association of Health Care Journalists, says in a statement. He notes reporters are forced to apply, usually through the public relations office, for each interview and often wait days for permission to speak to a staff member. Sometimes, they say, requests are ignored or denied.
The move comes in the wake of controversies over the drug approval process and product safety (such as Vioxx) and overseas inspection of manufacturing facilities, particularly in China (see the Heparin imbroglio), as well as numerous instances involving tainted food and related recalls.
The groups contend that restrictions have increased greatly in recent years, but nearly all prior administrations allowed “open, unfettered communication between agency employees and the media.” During the last two administrations, the groups maintain, rules have been implemented and grown steadily more constraining.
“We are tremendously heartened by President Obama’s pledge to create an unprecedented level of government openness,” says Kevin Smith, president of the Society of Professional Journalists, in the same statement. “It’s in that spirit we want to tell the administration that it’s not possible to do that and maintain these inherited constraints which did not exist under most administrations.”
[Full disclosure - Ed Silverman, who runs Pharmalot and is a bureau chief at the Pink Sheet, is a member of the Association of Health Care Journalists and signed this letter as an individual journalist.]
talbot
The fact that there’s something called a Transparency Task Force should be enough to give pause. Transparency doesn’t need a task force–that’s the point. Transparency means, what they’re doing internally is OK. And they’re happy to have anybody see that. Which means no preplanned interviews, gag orders on employees, etc.
Somebody–or many somebodies–either don’t understand what “transparency” means, or they’re so cynical they think that saying “we’re looking into this transparency stuff” will fool people whose livelihoods depend on digging for answers.
FDAer
The public wouldn’t believe what actually goes on at the FDA.
Restriction on access to the press is the least of it.
Managers routinely threaten reviewers. Threats are actually carried out and managers brag about it to other reviewers in order to intimidate them.
Is it any wonder that reviewers are terrified and very few will speak out.
Brian Orelli
I’m probably in the minority here, but I don’t want the agency opened up. The tight-lipped nature of the FDA puts retail investors on a (mostly) level playing field. Once staffers start talking to reporters freely, they’re likely to be a lot more loose lipped with analysts (who won’t share the information in the same ways that reporters will).
OK, I would actually like to know why they make the decisions they do, but that could be as simple as releasing CRL (although I’m sure the companies wouldn’t fight it all the way).
SLAPP Survivor
Freedom of speech? HA!
FDAer
I don’t think there’s much risk of FDA staff spilling any confidential commercial info. It wasn’t a problem before, FDA staff don’t spill such info now to their families or friends, and FDA staff can go to jail if they do. Plus we’re used to the companies themselves trying to pump us for info on the potential decisions and know how to handle ourselves. The problem is really the phone calls between FDA management (division directors and higher) about what’s happening with reviews that result in insider stock trades. Yes we often know when these things are going on. In fact when I realized it I was told by a group of more senior reviewers that it happens all the time.
The issue with speaking to reporters is really more about talking about processes and general policies after they are decided on. For example many policies are geared to favor specific companies and hide toxicities with their drugs. Reviewers should have the ability to talk about the published scientific literature and reveal problems with these policies or guidances. As it is now if you later challenge a drug because they don’t even meet published guidances that are too loose to begin with you are subjected to retaliation. Current policies prohibit reviewers from even saying anything that puts the agency in a negative light and violating this policy can result in official sanctions.
cliffintokyo
Talbot:
The Transparency TF mission might be to make sure that FDA publishes enough info (perhaps more like EU EMEA?) so that staffers don’t NEED to talk to reporters because there would be nothing to talk about if all the *non-con* detail is already *officially* out there.
FDAer:
“many policies are geared to favor specific companies and hide toxicities with their drugs”
Wow! Like, WOW!!
The great American public just might forgive
you if you had written “….to favor American companies…” BUT….
“…to hide toxicities with their drugs”
If, for one nanosec, I believed that, then boy, has Dr. Hamburg ever got herself a workload!
Suggest you go away and bake literal hot potatoes instead of political ones….keep you warm in your coming glacial old age.
FDAer
You may not believe it but I and others have seen it on multiple occassions.
When a potential issue is raised during the IND phase with a particular drug there will suddenly be ‘draft guidances’ within a matter of weeks. These draft guidances will be written in such a way so that they give a few pass to that particular drug, i.e. they will use the company’s proposed cut off limit for doing anything about a potential safety issue which will thereby prevent any additional work on the issue. The guidances then remain in draft form for years, not official but every company is essentially required to follow them as are reviewers and special permission is needed to go outside of them which of course never granted. These guidances will often not be finalized until years later right as the company’s drug is under review thus locking the free pass in stone. Some recent guidances have recently been issued that reflect science from over 20 years ago, while ignoring the more recent science in the area that would catch even more causes of those toxicities. This is done is such a way so that it never effected drugs that are now off patent and where the companies long ago included those limits in their internal criteria for screening out compounds. Meanwhile the newer science in not reflected as it might cause additional work or identify problems with drugs that are currently under development.
As for reporters. We don’t go to reporters as they’re not interested in the science. They want to speak to us when there are things they are interested in.
Cliff, Would you be interested in some lakefront property in the Sahara I have for sale.
SLAPP Survivor
Redundant to say, but FDA & industry are partners & this is what partners do for one another. Can’t retrofit FDA with ethics. More rational & realistic to take lessons learned & build new separate agency that is of the people, by the people, and for the people.
JaT
Best of luck in this endeavor. So much going on- so little information.
DTC ads being stringently regulated and FDA non-disclosure is a conflict in public safety.
On The Side:
Look into ‘branded generics’. Another win/win where drug makers can sell their products as generics (which approved ANDAs do make true- in my opinion) but also have the benefit of keeping brand names allowing them to sell the same products as branded drugs- depending on the country, or insurance company formulary, or patient preference, etc..
Some people will be paying more for the exact same product.
harry
pharma reporters have agendas too. the rule prob cuts down on the flow of bribes to lower level employees. in the future, fda has to engage with all consumers not just a select group of reporters and their pharma friends. that is democratic.
cliffintokyo
FDAer;
Thanks for your suggestion.
Actually, I am thinking about moving out, but my Eastern connections limit my horizons for the present. Waterfront vista would be cool, though!