How The FDA Will Spend Some PDUFA Fees
7 CommentsBy Ed Silverman // May 7th, 2008 // 7:56 am
Where will the money go? Well, the agency says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act, FDA News reports.
The agency plans to spend fees to fund epidemiology “best practices” and data acquisition ($7 million in fiscal 2008, increasing to $9.5 million in fiscal 2012); new drug trade name review ($5.3 million in fiscal 2008, rising to $6.5 million in fiscal 2012); and risk management and communication ($4 million in fiscal 2008, rising to $5 million in fiscal 2012), according to FDA News.
In a draft Drug Safety Five-Year Plan that the agency updates annually and issued for comment last Friday, the FDA signals its intention to use the fees to increase the number of employees dedicated to adopting new scientific approaches to drug safety, reducing the risk of medication errors and improving adverse event detection and prevention programs, FDA news continues.
The FDA blamed problems in adverse event reporting on “underreporting, the often poor quality of reports and the lack of systematic feedback to healthcare providers and consumers.” Mea culpa? So the plan calls for hiring a contractor “to study the various mechanisms for collecting adverse events and determine optimal strategies for collecting adverse event data throughout the product lifecycle,” FDA News writes.
Dan
Those are words. Let’s wait and see if they are followed by actions obligated by such statements.
Justice in Michigan
And words we have heard many times before - not only in the last five years, or fifteen years, or however one wants to slice it.
When you add up the numbers, drug safety remains a very small proportion of PDUFA funding - bigger than it was, yes, but still a very small proportion.
And what is “trade name review”? I understand some drug names can be too much like each other and cause serious problems. But this is more $ than committed to “risk management and communication” and almost as much as for “data acquisition.”
We’ll see.
Justice in Michigan
Good grief again. Went to the original release that Ed well summarizes and was struck again by this bit:
“The FDA cites problems in adverse event reporting for marketed drugs due to “under-reporting, the often poor quality of reports and the lack of systematic feedback to healthcare providers and consumers.” To address this, the agency plans to hire a contractor “to study the various mechanisms for collecting adverse events and determine optimal strategies for collecting adverse event data throughout the product lifecycle,” according to the plan.”
So are we to understand that there is no one at FDA itself who already knows enough about “the various mechanisms for collected adverse event data” etc.?
This is the gold standard agency whose rigor and unquestionable expertise the preemptors are always telling us about?
It if weren’t grotesque, it would be funny. As it stands, it’s simply grotesque.
Bob Freeman
One of the very disturbing trends, in my opinion, is the privatization of essential government services. This is just another example of taking another essential service and outsourcing it.
To your point, Justice, I don’t believe the FDA is staffed adequately to communicate effectively. Instead of addressing fundamental infrastructure, it’s “easier” to out-source it.
Regrettable.
Justice in Michigan
Pitiful indeed, Bob. As you well know, these problems have been assessed at least since the 1970s in NSF reviews of the FDA. And now that there is a tad bit more PDUFA money, suddenly it becomes possible to … well, maybe find someone, who, well, maybe knows something, about, well, some of these things….
I’m not mainly blaming the FDA. As I’ve said elsewhere, and in synch with what you’re saying, the agency has been starved to death for years - by successive administrations of both major parties and by Congress (of both major parties).
I wonder again what sort of national death wish this expresses?
Bob Freeman
Indeed, Justice. I don’t find that fault lies with the agency other than the recent appointment of shall we say less than competent Commissioners. I believe that the Agency was headed by “acting” Commissioners for much of the past seven years.
It’s fairly obvious that drug safety has not become a national public health priority at least as far as the appropriations process is concerned.
Dan
Have They Switched Sides?
The Food and Drug Administration originated in its primitive form at the time several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed, as they appear to have formed a pathological alliance with the pharmaceutical industry through the money the industry gives the FDA for various reasons, yet so large amounts of funds are issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income. Results of this relationship, one could posit, have been the approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform, and have failed to do so as much as they should for our benefit.
And the intimacy between the two organizations seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and some have been penalized for this behavior in the past in the form of monetary settlements with the Department of Justice.
This FDA protocol that is being considered, called, “Good Reprint Practices”, would require reps to use what does not truly exist, which is truthful and authentic clinical trials when they do speak off-label to prescribers. This in itself lacks etiology for such discussions by reps, as most clinical trials are flawed due to the trials being possibly manufactured by the pharmaceutical companies of the meds involved in such trials. Additional trial deception involves ghostwriting and invalid authors of such trials. These facts can be validated and have been discovered by others.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability to analyze data regarding this issue accurately is unlikely, for the most part, I surmise. This complicates the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into our harmful association by suggesting such practices with deliberate intent and reckless disregard for public health, so it seems. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse.
However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that are overall covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves.
“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
—- Carl Jung
Dan Abshear