Should The FDA Have Mandatory Recall Powers?
58 CommentsBy Ed Silverman // May 28th, 2010 // 10:07 am
That’s what Ed Towns would like to see. The chair of the House Committee on Oversight and Government Reform, which yesterday held a hearing into the Johnson & Johnson recall scandal, vowed to introduce legislation that would permit the FDA to be able to conduct mandatory recalls (see this).
This came after hearing how Johnson & Johnson’s McNeil Consumer Healthcare unit committed numerous violations - various pediatric meds, including Children’s Tylenol, may have contained too much active ingredient, metal specks or inactive ingredients that failed testing requirements, according to testimony by FDA deputy commish Josh Sharfstein. There were also lengthy and inexplicable delays in reporting and rectifying the problems. Moreover, a contractor was hired to surreptitiously remove Motrin from stores, which amounts to an unannounced recall (see the memo).
In the wake of consumer complaints and more than 30 deaths that some congressman tried to blame on J&J, the FDA has referred the episode to its Office of Criminal Investigations. But some committee members want to go further and allow the FDA to mandate recalls, rather than wait for drugmakers to take voluntary action. Right now, the FDA does not have such power. What do you think?
Should The FDA Have Mandatory Recall Powers?
- Yes (86%, 96 Votes)
- No (14%, 16 Votes)
Total Voters: 111
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Justice in MI
I would be genuninely interested in hearing from those who voted “no” on this question. What are the best arguments against?
As I recall (so to speak), having such powers was part of an early version of the FDAAA but, like a lot of other good things (in my view), it was removed.
Of course, we know that FDA can, legally, move to enforce recall if a company balks, and we know that very rarely happens. I think there are only one or two instances in which FDA went through the kind of sustained legal process needed to enforce a recall.
My students are consistently amazed FDA doesn’t already have this authority. I’d guess the vast majority of folks assume it does.
Cliff Mintz
While FDA cannot unilaterally remove products from the market via a recall, it does have the ability to pressure companies through a variety of administrative and judicial actions to induce companies to recall products that are tainted.
The bottom line here is that FDA is usually well aware of issues before products are recalled. In other words, FDA tries to manage these problems behind the scene and out of public view. Companies know that FDA is underfunded and understaffed and as a result non-compliant companies know that have enormous leeway with regard to regulatory action. I think what is becoming readily apparent was how ineffective the FDA had become under the eight years of the Bush regimen. Unfortunately, it will take many years to fix the internal problems at the agency. At least the Obama administration is aware of the problems and taking positive steps to correct them
Condor
I voted “yes” — FDA should possess this express power.
Having said that, I do think this issue gets more ink than it might really need.
Except for handling truly fly-by-night fraudster entities, the power (while desirable) is probably not actually needed, as a practical matter, in the vast majority of cases.
In the vast majority of cases, the drug company will want to be able to remain “in business“, for the long haul. As such, the drug company will not want to force the FDA to go through proceedings to order the entire line in dispute off of the market. That would amount to a long-term business-killer.
I do support giving the FDA this express power — once a company says in writing it will not immediately recall “XXX-YYY batches” of a given drug — I just think most companies (if they don’t want to be regulated completely out of existence) will see there is no percentage in pushing it, over the long haul.
In truth, if one company flouts the FDA’s authority in writing, the FDA has every right to conduct intensive inspections (as such written refusal amounts to probable cause that other violations are being condoned inside the company’s plants), week after week after week — in each of the facilities of that company. And we all know — from hard experience — that if FDA looks closely enough, it will find at least some minor “record-keeping” violations — in practically every facility of size. Even at the best of the best.
So — except for truly sleazeball operations (ones trying to make a killing in the US market, then flee our shores, to a non-extradition treaty-haven) — i.e., the truly rare case, the practical utility of this power is likely overestimated.
Just my $0.02.
Namaste — remember the war dead (of all nations) this weekend.
pharmavet
If you study the “Pink Sheets”, you’ll find that there are thousands of recalls every year, the vast majority in the food arena. As JiM said the voluntary recall system, with FDA exerting pressure behind the scenes has, with one or two exceptions worked well over the years. The FDA allows the company to recall their own products based on a Roman Numeral Classification system depending on the seriousness of the problem. This is a system that has actually worked well. Most of the time the company initiates the recall on its own, then notifies FDA in timely fashion.
One example is about 10 years ago my company initiated a voluntary nationwide recall of a product because of excess peroxide in the cotton that plugged the bottles. The drug was being oxidized and became subpotent. We formed a crisis team, initiated the recall, quickly informed the FDA and got the problem fixed. Consumers were compensated for their monetary loss.
Another reason that I vote “no” may be less apparent. FDA firmly sticks to its mandate not to interfere in the practice of medeicine. By empowering FDA to mandate recalls they will be open to political influence as to what and what not to recall. This is de facto practicing medicine because FDA is limiting choice. Don’t believe that the FDA is immune from being influenced. Anyone who has studied the generic drug scandal of the 1980’s will know what I’m talking about.
JiM, I don’t know what you teach, but if it involves the law, your students should be reminded that The Bill of Rights LIMITS the power of the Federal Government to encroach on our freedoms, one of those freedoms is not to have a regulatory agency determine which drugs we should be entitled to outside of its role in the drug approval process.
Texas RA
I voted no, and thought I would share my thoughts. I believe that the FDA needs to be able to protect the public, but not at the loss of due process (Fifth Amendment) or the risk of unreasonable seizure (Forth Amendment).
The FDA like many of us, sometimes draws a conservative conclusion before getting all the facts. I personally have been involved in approximately 50 FDA and 100 state health agency inspections, and I have witnessed incidents where the agency made a wrong interpretation of the law and it wasn’t until the appeal process, where the observation(s) were overturned. If instant recall authority had been exercised, it would have taken months to years to recover from the lost revenue and damage to the trade name.
As Condor mentioned, the majority of companies are looking at the long term affects. Also, most companies will comply with an FDA request for recall, or actually do a voluntary recall to show good faith. A company does not want to deal with a long term battle with the FDA which could end in consent decrees, closure, and/or trade name damage to the extent customer trust becomes non-repairable.
As mentioned earlier, I fully believe the FDA needs the power to protect the public. I just feel that there needs to be some level of check and balance. A simple review from a federal judge would work.
M. Black
“Office of Criminal instigations”???
Is EVERYONE at J&J bedridden? Seems like FDA knows what’s going on, but don’t want to touch it with a 10 foot pole, because the FDA doesn’t want to avoiding any fingers thrown at them.
For things like this to stop, DRAMATIC fines need to be drawn. Removal, jail time, redicuously massive fines, and shutdown with facility, production, testing, released materias processes, qualification of vendors use, etc.
The legal “to set examples” should be applied in many cases.
“Mommy, why is Daddy in jail?”
“Because he is a crook, honey.
That needs to happen to get rid of the “fines are just costs of the business” philosophy will light a fire to EFFECTIVELY get these bastard companies?
To FDA: Tou suck. Retire ASAP for the good of society as a whole. You are failing miserably.
~M. Black
Condor
While I do not share (that portion of) the view expressed by Texas RA and Pharmavet — that these matters raise the spectre of unconstitutional searches, seizures or other violations of the Bill of Rights, I do see the intuitive appeal of what they’ve written.
It happens that, when one sells an inherently dangerous good — a drug, biologic or medical device, to be precise — into interstate commerce, the existing federal scheme permits, in fact demands, a high degree of vigilance from both the manuafcturer, and the regulator.
So, in short, these are not fundamental “rights” cases — these are “privileges” cases: there is no “right” to sell prescription drugs — only a “privilege”.
And that “privilege” may be foreclosed — in any number of ways — without offending the Constitution. That said, the FDA doesn’t want to unduly interfere with the physician patient relationship — so long as the drug is deemed “safe” (and recalls generally speaking are matters of safety), that is.
Great dialogue!
I am still convinced that FDA ought to hold this power, even if it would only — as a matter of practical effect, use it sparingly — and then, only after a manufacturer refused in writing to address an FDA safety or efficiacy concern, in good faith. It just won’t come up all that often.
Namaste
JaT
Playing devil’s advocate:
It could lead to some very beneficial favoritism. I’ll stop short of getting into the existing situation of fast-tracking.
I haven’t voted- but the ability to pull a product doesn’t change that the FDA reaction to damages is far too slow. On the surface it does seem reasonable that FDA should be allowed to use any tool available to them- for our safety. Maybe if they had done more to keep me safe while participating in their CRADA…
“Since pilot-scale manufacturing facilities are not available at the FDA, this collaboration provides the Agency with an opportunity to conduct on-line research related to the implementation and validation of PAT tools. It also provides access to Pfizer’s industry leading expertise in the area of on-line PAT and chemical imaging of pharmaceutical products.”
Could some ~select~ tails wag the dog?
Condor
No doubt, JaT, no doubt. But it was always thus. That is, having the power won’t change that, will it?
I don’t think you mean to suggest that FDA would wrongly order a drug off the market to improperly benefit a favored competitor to that company, do you?
For my part, I’ll sleep soundly knowing that FDA is highly unlikely to engage in that level of improper gamesmanship (at least for so long as a Democrat remains in the Oval Office).
Kind regards.
Justice in MI
Good points. I think some of the specific cases are relevant–how many times has FDA ever seriously suggested recall when, later on, it turned out not to be warranted? That history is relevant.
Re: Vet’s point, this is not a law course, but it is one on the stuggles to find the right balance of regulation and lack thereof. I do not agree that “one of those freedoms is not to have a regulatory agency determine which drugs we should be entitled to outside of its role in the drug approval process.”
The FDA does a lot more than approve drugs. That’s why we have ORA, the OCI, regulation of promotion, etc. etc. etc.
Vet’s point seems to me to be at a level of generality that misses the genuinely tough questions re: extent, form, and arena of regulation.
Anne PME
Question: If the FDA is given the right to recall, who would be responsible for paying the bill?
Condor
The company, Anne.
It is a “privilege” to sell the prescription pharma products — avery valuable one, at that — one that garners VAST profits, and so, manufactureres must be willing to bear some additional “safety” costs, if the recall implicates safety. Seems fair.
[I am tempted to say -- by analogy, here -- BP (which earned literally "world record" profits over the last few years) is likewise required to pay to clean up the Gulf of Mexico -- but we can't be sure that will happen -- yet.]
Namaste
Stephany
Condor said, “I don’t think you mean to suggest that FDA would wrongly order a drug off the market to improperly benefit a favored competitor to that company, do you?”
That just rolls off the tongue doesn’t it?
JaT
No Condor,
My thought was more in line with FDA not having the capability to conduct their research without a drug makers assistance. Because it was Pfizer’s process, no one knows better than Pfizer how to get the results they want. FDA did approve the product under different criteria than usual. How do you go back and say ooops after you praise your own work and the drug makers facilities? So favoritism, whether for CDER to sing it’s own praises- and/or Pfizer’s, is suspect. The results were never really addressed. FDA found it acceptable. You have to wonder if they would have accepted it without their own participation.
Texas RA
I agree Condor. This is a great dialogue. It is nice to have a grown up conversation about controversial topic. Also, thanks for pointing out privileges cases and rights cases. I never thought of that POV before.
Quick question. Even though selling a pharm product is a privilege, doesn’t the due process law fall under constitutional law (i.e. not just a right, but a law)? For example, once a firm has the privilege of interstate pharmaceutical commerce (i.e. state licenses and federal registration), wouldn’t the due process law still be applicable to the firm’s rights under constitutional law?
Sorry I’m not a lawyer and would like to understand the privileges cases and rights cases a little more. Thanks.
Stephany
Which drug was that pharmavet?
Texas RA
Justice, I’m not sure your comment, “how many times has FDA ever seriously suggested recall when, later on, it turned out not to be warranted?”, was a response to my early comment, but just in case it was.
My initial comment was directed to the FDA making errors in recall orders if they had mandatory recall authority without a check and balance system. At my firm, we have experienced 3 incidents within the last 5 years (including 1 warning letter), where the initial FDA ruling was incorrect and retracted. With the warning letter incident, I could see the FDA potentially exercising their immediate recall authority if they had it. In our case, it took a couple weeks before the FDA retracted the warning letter. In 2 weeks, the trade name damage and lost sales would be tough to recover from.
JaT
Okay, yes that is exactly what I meant. Favoritism for some companies over others. It is no secret that pharma has pilfered FDA of their employees. It’s a pretty cozy relationship, IMHO.
If I’m not mistaking, FDA made a call for better ways to monitor drugs in about 2005- and the companies that came through with those systems had to be appreciated. One of the questions that came up is- why would a drug company go to the expence of changing a process for a drug as old as Dilantin. It had to be quite the investment. It was probably on the tax payers dime for research.
Justice in MI
Thanks, Texas RA. Yes, I was thinking of such examples. I think a mistaken recall goes far beyond a warning letter, but I take your point.
It occurs to me another issue enters in. Even within our present system, if the FDA advises recall, and the company balks, not only will there be potential litigation between the two, but I would assume the company’s vulnerability to product liability suits would also significantly increase. Certainly, the burden to prove FDA was wrong would be substantial. Among other reasons, I assume that’s also why companies so rarely balk when FDA reaches that point.
Cassandra
Look at it from the other end: Giving the FDA the authority to order a recall, would also make it responsible and accountable. As the law stands, the FDA can probably pressure a company into issuing a recall. But as it does not actually make the decision it is not accountable for what it chooses to do, or perhaps not to do.
Towns may appear to be targeting J&J, but I think there also is a real concern that the FDA did too little, too late — and that it is using its lack of formal authority as an excuse.
Texas RA
Agree Justice. The company’s vulnerability to product liability is a major concern. If the FDA requests a recall, a firm would really need to think it through before venturing out on the limb and say no. Luckily, I’ve never been in that position. The firms I’ve worked for have all been very proactive and typically execute a voluntary recall before the FDA even gets involved.
Condor
Again — lovin’ the diverse, and thought-provoking, dialogue underway here.
Texas RA asks:
. . .For example, once a firm has the privilege of interstate pharmaceutical commerce (i.e. state licenses and federal registration), wouldn’t the due process law still be applicable to the firm’s rights under constitutional law?
As my Con Law Prof used to say, the key question — for certain — is “how much process” is “due“?
That is — if the state proposes to take your liberty, for the rest of your natural life, you are “due” a pretty significant amount of “process” (procedural safeguards, via presumptions of innocence, right to confront witnesses against you, etc., at trial).
If, on the other hand, you were selling very dangerous fireworks (albeit lawful ones) — and a kid lost his hand (or eye), when one exploded (while the kid was still inside the store, in line to purchase it — to make it a truly provocative example), we would all probably agree that not too much “process” would be “due” — before we ordered that brand of fireworks off the shelves, right? I do think so.
Certainly, we would not require a full-trial on the merits, and a series of appeals all the way to the US Supreme Court, before we empowered the state fireworks commission, or the federal ATF to sieze the goods.
So — in practice — “due process” varies, depending on the interests at stake: a death penalty case? BIG processes are “due”.
Selling a very-dangerous good? Much smaller “due process” — by state — need be shown.
Hope this helps.
Namaste
Salmon
I expect that if Congress gives the FDA the power to demand a recall then any such law will have provisions for due process.
Since yesterday there have been news reports of possible criminal charges against JNJ. If you look at the Food Drug and Cosmetics Act Chapter III Prohibited Acts and Penalties there the following section:
21 CFR SEC. 305. [21 USC §335]
Hearing Before Report of Criminal Violation
Before any violation of this Act is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding.
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIIIProhibitedActsandPenalties/ucm107319.htm
The FD&CA also has specific due process procedures before taking drugs off the market due to safety issues (remember Vioxx), if the drug is to be condemned and seized as misbranded or adulterated (which may occur with the JNJ products), as well as if a new drug application is turned down.
As I said any changes to the FD&CA would entail a specific process.
Salmon
pharmavet
Stephany, the drug was Synthroid, which at the time was the third most frequently prescribed medication in the United States. Given the drug’s popularity, I’m sure that if the FDA had ordered a recall and made it public, it would have triggered a panic among the 14 million users of the product.
When we did the recall we kept FDA abreast every step of the way. We established a critical path task force, which inside of one week traced the problem to a faulty peroxide removal process from the cotton in one of our major repackaging plants. Working 24/7, within one month we had an alternative repackager validated and up an running. A nationwide alert to all pharmacies with the defective lot numbers was done within seven working days. Every member of the crisis team was on call 24/7 until all pharmacy shelves were fully restocked.
This was all accomplished behind the scenes, without assistance from FDA and without panicking consumers. This is why I am confident that industry can handle these situations without FDA mandates.
As far as I’m concerned our experience would qualify as a case study for the Harvard Business Review on how private enterprise can clean up its own problems without government interference. I would recommend it to Interior Secretary Ken Salazar before he threatens to “keep the bootheel of the federal government on the neck of BP”.
Justice in MI
I agree with Vet that self-regulation is the key, and is successful most of the time. As we’ve discussed here before, companies will always know more about their products than FDA. The key is what they do about it.
Again, it’s about balance and ways to incentivize the kind of self-regulation Vet describes. There are many such stories. And there are also those instances (which, indeed, get more attention here) when a different tale prevails.
So, again, invocations of “bootheels” does not help think through rational and effective regulatory policy.
Justice in MI
I agree with Vet that self-regulation is the key, and is successful most of the time. As we’ve discussed here before, companies will always know more about their products than FDA. The key is what they do about it.
Again, it’s about balance and ways to incentivize the kind of self-regulation Vet describes. There are many such stories. And there are also those instances (which, indeed, get more attention here) when a different tale prevails.
So, again, invocations of “bootheels” does not help us think through rational and effective regulatory policy.
M. Black
Cliff,
As a response to your first question, yes, the FDA is understaffed. However, this is not necessarily a prerequisite as it sounds to progress. It’s the decisionmakers and those writing the 483’s and warning letters. In fact, I’d take half of the numbers of staff with twice as much ::ahem:: enforcement.
MB
M. Black
The most effective change begins from the inside. Get there, then do it if it’s needed. Seeing it and whining on a blog site is a waste of time, and for the most part does nothing to achieve the desired result.
MB
John
Excellent thread, I learned quite a bit from the comments above.
My 2 cents: The European system, in which the European Commission can withdraw marketing authorization for a drug (and has done so on the recommendation of the EMEA in the case of Acomplia, for example), seems to have worked reasonably well.
patrons99
@ Cliff - “I think what is becoming readily apparent was how ineffective the FDA had become under the eight years of the Bush regimen. ”
Amen to that. Mercifully, we’re beyond that regimen. I voted yes to mandatory recall powers.
On the subject of FDA reform in general, has it now reached the point where FDA has far too much on its plate? Why not break it up, into a few autonomous units? e.g. safety, devices, biologics, drugs, foods. Then chronically underfunded, understaffed units can be more readily identified.
Stephany
thanks for the explanation pharmavet–
Though it appears to be a smooth self-regulated recall, the problem I can see with that not going public via an FDA announced recall, are the patients who had a supply of Synthroid on hand who used the drug due to having say a 3 month supply etc. Esp with regard to Thyroid regulating, it gives a chance to look back and wonder if for example someone having a ‘dip’ in wellness could have actually taken a non-potent drug.
I don’t believe it would have caused panic, in fact I believe public announcements with lot #’s etc given to the public empowers consumers to be diligent and watch their meds closely.
I remember one time when Zyprexa and Zyrtec were being bottled erroneously by pharmacist error due to the “Z” and Lilly changed the bottles to ZyPrexa, so that wouldn’t happen again—imagine an allergy med switched for an antipsychotic!
Thanks for the discussion, this thread is interesting from all commenters.
patrons99
Yes, this thread has a lot “nuggets”…food for thought. Sorry, I can’t resist “bootheels”. BP and castrophe in the Gulf is a perfect example. Here is where the federal government needed to step in much sooner. Leaving the crisis to BP to manage, alone, is unconscionable.
Another perfect example is the recent non-human DNA found in rotavirus vaccines AFTER it was administered to about 31 million “subjects”, worldwide. Here, the FDA stepped in and applied the Precautionary Principle. This was prudent, from where I stand.
We need an FDA, but perhaps it should be revamped. It’s sheer size alone, has to be a challenge to manage. There needs to be an autonomous unit focusing solely on ethics, and making tough decisions as to when and where it is appropriate to apply the Precautionary Principle.
patrons99
There are regulatory “turf wars” between DOJ, OIG, and FDA. This makes for a confusing state of affairs. It provides the opportunity for a lots of “buck passing” whenever it’s politically expedient. If you pass the buck often enough, and enough time goes by with relative regulatory inactivity, many “problems” will just quietly whither on the vine. In whose hands should the real regulatory “teeth” lie? DOJ? OIG? FDA? Perhaps, FDA has been relatively feckless as a regulatory body is that it lacks regulatory “teeth”…it’s basically edentulous.
pharmavet
Stephany, here’s the irony of the drug naming issue. When a new drug is in the approval process, the company submits a list of proposed brand names to the FDA for clearance. FDA then either approves or rejects those names based on a number of criteria, with similarity in spelling or pronunciation being one of those criteria. Once the company receives the name approval from FDA, it then proceeds on its branding and brand awareness campaign, which usually costs in the tens of millions of dollars.
After the product is launched, if there is a problematic pattern in the marketplace such as Zyrtec Rx substituted for Zyprexa or vice verse the FDA will order said new product to be renamed. This involves recalling and destroying tens of millions of dollars worth of drug, literature, package inserts marketing materials DTC ads, not to mention all of the pens, pencils, paper weights and coffee mugs, etc that pharma used to give away. The company’s product is now misbranded through the fault of the FDA. How much monetary compensation comes back to the company for the FDA’s error? I’ll give you three guesses. If they are all zero, then you are correct.
The most egregious and expensive screw-up in this regard was when FDA approved the original name of Astrazeneca’s product Losec (omeprazole) for GERD. There was reported confusion and pharmacy switches with the product Lasix, which is a diuretic. AZ then switched the name to Prilosec. What then began as the FDA’s error ultimately was passed on to the patient in terms of higher costs.
If we mandated electronic prescribing and got rid of hand written Rx’s, that would go a long way towards solving this problem and saving wasted money.
pharmavet
Patrons, to be fair to the Bushes, Dr. David Kessler, arguably one of the better FDA Commisioners was appointed by President George HW Bush in 1990.
M. Black
If there is “too much on the plate of the FDA,” then dispose of the utensils they
ate using permanently, impose absurldy massive, life-breaking (NO EFFING PARACHUTES OF ANY COLOR) fines on FDA employees that didn’t live up to their own jobs, and, if necessary, inprison in addition to fine those who knew what was right and wrong, and did not do it. If we don’t do this NOW, while there is a fleeting chance of success, the door of opportunity may close for at least another generation.
SWIFT and MASSIVE will blow the hell out of “shock and awe”.
And pray Barry-O tackles this problem in a no nonsesnse way, which will send corrupt Executives, and heck, middle management to face massive fines and imprisonment.
Examples must be made ASAP. As in NOW!
When you see it, then get the urge to just swallow it, DON’T. Spit it out through official means and spend less time bitching about it.
As for the ever pampered and whiny baby boomers who saw their dream of retirement shrivel away because they put a jackass in office for 8 years, cry me a river and get your @$$e$ to work.
DO SOMETHING FOR JHC’s SAKE.
~ M. Black
patrons99
M. Black - Wow! Let it never be said that you are not passionate about this stuff! Bravo!
But…perhaps you might want to chill-out for a little bit. You’re about to blow a head-gasket. We’d hate to loose you.
Sincerely, Whiny baby boomer
Lana Keeton
The question is: If the FDA had the power to recall, would they use it?
They do not currently use the full regulatory authority they have (think patient labeling for medical devices) to protect patients. There is supposedly a 3 year investigation of synthetic surgical mesh ongoing at the FDA. Yet they have done nothing to warn patients considering hernia repair with mesh of the thousands of adverse event reports currently in their data base or the nature of the irreversible complications.
Lana Keeton
Truth in Medicine
Patient Advocate
patrons99
@ Pharmavet 1:45 PM -
We might need to get our seafood from the West Coast, henceforth, given the quantities of crude oil, detergents, and heavy mud, being pumped into the Gulf.
Where are all of those Republicans now, who shouted “drill baby drill”?
Where are all of those Republicans now, who shouted “go Pharma, go” during the 8 dreary years of the Bush regime?
It feels like the world is getting a whole lot smaller. Will man’s hubris lead to our extinction? Will runaway “science” and Pharma be the death of us all?
I am a former Pharma, former Republican, baby boomer. Now, I’m an independent. I’d have to say that Donna Shalala was preferable to Tommy Thompson over DHHS. As for John Ashcroft’s tenure over DOJ, well, you be the judge. I have concerns over Margaret Hamburg’s “independence” from Pharma.
http://www.toxicteeth.org/natcamp_fedgovt_fda_ethical_problems.cfm
http://www.truthout.org/how-bushs-doj-killed-a-criminal-probe-into-bp-that-threatened-net-top-officials59648
http://www.scribd.com/doc/17300806/John-Ashcroft-the-PDUFA-and-the-Federal-Judiciary
pharmavet
Patrons, I’m not a conspiracy theorist but there are some who believe that Obama deliberately delayed the government’s response to the BP spill in order for the spill to grow out of control and make the anti-drilling efforts of Obama’s extreme far left wing environmentalist supporters a self-fulfilling prophecy. Republican La. Governor Bobby Jindal was rooting around on the mud-slicked coastline before Obama was even sized for work boots. His main man Rahm Emmanuel was out of touch while vacationing in Isreal, and Obama had to be talked out of a second vacation in 40 days.
There is an old band you may remember called “Asleep at the Wheel”. The administration’s response to the oil spill is a good metaphor. Still waiting for Ken Salazar to put those bootheels on BP’s neck.
Obama may be a slick politician, but he has no answer for this “slick” In addition to his eloquent request to “plug the damn hole”, maybe he can make a side trip to the Minerals Management Agency and shake them up, or at least get them to stop watching pornography while the oil well gushes.
As a student of marine biology at The University of Miami in the late 1960’s I know something about the fragility of marine life in the Atlantic and the Gulf. The largest living coral reef off Key West is threatened by extinction. I do give kudos to University President Donna Shalala, however. She has turned UM into a top tier school.
patrons99
@ Lana -
“The question is: If the FDA had the power to recall, would they use it?”
Excellent point! Enforcement actions requires a certain degree of political will from above. Even with the power to recall, FDA could easily continue to suffer from regulatory malaise. Couple this with the wrong-headed notion that Pharma will police itself, is a recipe for perpetuation of the status quo. The status quo is unacceptable. People are literally dying, in increasing numbers.
pharmavet
Patrons, you speak of Pharma as a monolith in terms of Pharma not policing itself. There are many examples of successful self-regulation, per the exmaple I stated above, so that we should be careful not to paint with too broad a brush. I admit that there is no such thing as the perfectly executed self-regulated recall, but given that some manufacturing plants have not been inspected in 10 years (instead of the self-mandated two years) do we really want to wait for the FDA to mandate recalls? Even today, as someone above suggested why doesn’t FDA use its enforcement powers to shut down plants? They can do this at a moment’s notice, bring in the US Marshall’s service if necessary, and padlock the doors.
pharmavet
Patrons, I agree. M. Black needs to chill out.
John
JiM, Condor, Pharmavet and others got this thread off to a remarkably good start. Looking back over the posts, the key seems to have been setting a tone of genuine interest in the POV of others, focusing on shared values, and avoiding presenting one’s own conclusions and opinions as established facts. In short, excellent party manners.
I will try to do a little better at this myself.
patrons99
Thank you, John. Very well stated. I too will resolve to be less dogmatic, less confrontational, and more polite. Sometimes I feel outnumbered, though. But hey, we’re all grownups here. I shouldn’t blog if I can stand the heat. Ed’s pharmalot blog is an invaluable resource for analyzing current events and trends in Pharma. Without pharmalot, where are we going to find the uncensored, unedited, dialogue and debate?
M. Black
I’m chilled, no worries.
However, people need a good tazer-ing in a special place to change what we all claim we care about.
MB
Mr. Experience
For the most part, those that post here are judgmental wind bags.
The question if the FDA should have mandatory powers is easy to answer. Why give them more control when they can’t take care of their own house?
I am sure I will now get more superfluous paragraph after paragraph answers,(maybe even pages)where one short reply will do.
Some of you remind me of the person who asked what time it is and a bloated response about how to build a clock.
JaT
Interesting how some of these subjects move to poilitics and party. Not every republican administration has a republican congress- or the other way around. It isn’t completely unimportant but is worthy of consideration. Considering the potential change of power every 2 or 4 years, and considering how long it takes for FDA to recognize and alert consumers to a problem, party doesn’t feel very relevant to me- as an independent. Drug makers know this and lobby both sides fairly equally. That does not go so far as to say that I don’t believe republicans are more sympathetic to drug makers. Just that both sides of the aisle owe favors.
Because of this, my thinking on most decisions usually leads to- just because you trust this administration with something- will you trust every future administration with the same power?
patrons99
Pharmavet -
The problem I have with Pharma continuing to police itself is this. It’s discretionary. How can anyone serve two masters? Corporate profiteering ($$$) and the public safety. If Pharma knew that FDA held a sword (mandatory recall) over their heads, might they be more apt to initiate voluntary recalls?
The way the system is now, Pharma knows that FDA is effectively edentulous. Who is really looking out for the “endangered and the dead”? Pharma? FDA? Other? Does anyone deny that people are dying in greater numbers?
It gives some comfort to see that the poll was about 9 to 1 in favor of empowering FDA. I guess we could start a petition to Congress. Maybe pharmalot should spin off a political action arm?
Cassandra
The case for self-regulation is that it serves the long-term interests of pharma best. The case for government regulation is that on the short term, pharma companies may take a different view. It is hard to separate the “slow and unsatisfactory” response from J&J that made the FDA so irate, from the possible reluctance of its managers to order yet another Tylenol recall. And while J&J’s senior management was warned again by the FDA in February, it is tempting to think that they didn’t want to raise a stink shortly before J&J’s annual meeting of shareholders, which was held late in April and generally gave the directors its blessing.
The logical conclusion is that self-regulation would work better if the penalties for flunking it were higher. Although I still think that giving the FDA the power to order a recall would be beneficial, I am sensitive to the argument that the effectiveness of this would be limited because it lacks the manpower to inspect frequently enough, or the will to actually order precautionary recalls. Self-regulation could potentially be more comprehensive.
But to make it work better, the penalties for neglect might need to be raised. Although the FDA has been extracting huge fines in some recent cases, that doesn’t seem to affect the behavior of companies much. Besides, the companies are likely to recover such fines in their pricing, and therefore ultimately from the taxpayer. Criminal prosecution has been threatened in this case, but convictions are almost unheard of. Perhaps it is time to get tougher.
We could also consider some innovations. Perhaps, as considered in the banking sectors, denying the senior management a bonus if a disaster happens under their watch. Losing the patent right on a product might also be sensible penalty for companies that go too far wrong in its development, production or marketing — although the patent is irrelevant in this case, the FDA’s decision to recommend generic alternatives comes close.
ex-FDAer
I don’t think mandatory recalls will mean much.
Currently FDA has a mandatory obligation to pull marketing authorization when drug approval is based on fraud.
There are a number of cases where FDA management is aware of fraud by drug companies that entail significant public health risks. Even with this mandate for required pulling of approval FDA does not do anything. In fact FDA managers are actually complicate with companies in perpetrating these frauds by interfering with the staff reviewers. It’s well known by FDA staff that one of the worst offenders in this regard (as well as the companies involved) admit to them communicating outside approved channels and within a day or two it’s clear that there’s interference by this or other managers. Even so when safety signals are seen this senior manager will tell reviewers “where are the bodies in the street” i.e. the press and Congress isn’t yelling at us to loudly yet. This manager will even deny that safety signals that have been clear predictors for drugs killing people and the drugs being pulled from the market mean anything at all.
No I don’t believe having the mandatory recall authority will amount to much. I still think it’s worth a shot and besides at the very least politically it will seem like Congress is doing something.
Condor
Mr. Experience writes:
“. . .The question if the FDA should have mandatory powers is easy to answer. Why give them more control when they can’t take care of their own house?”
I’ll be brief: His is a classic non sequitur. If pharma has compliance problems — it does, in my opinion — and the agency empowered to regulate it doesn’t have a needed power-tool (note here, however, my view that perhaps this power’s practical utility is overstated) on its work-bench — then bestow that power. The issue is pharma’s non-compliance, not the FDA’s less than perfect track record. Unless Mr. Experience proposes a new regulatory scheme, his answer is. . . no answer at all.
Simple. Short. Clear. Don’t be duped by arguments with premises and conclusions that are not logically connected.
Namaste
Mr. Experience
Okay, no real argument there but, I look at the whole picture, not one thing and then the next, etc.. I have seen more FDA executive changes than a baby diaper sale (don’t forget interim executives). To have more authority could be dangerous, as they haven’t run their ship smoothly with what they have. One has to show their value before moving onward. (Sticking to my earlier comment, this is short.)
M. Black
Tough times demand tough talk, followed by tough actions.
MB
R. Boyce
How could VAERS play in here? What if a drug or vaccine is showing a majority of adverse events in the VAERS system, then clearly there is argument for giving the FDA the ability to recall something like this. Gardasil is now showing 23% of the ENTIRE database … should the FDA really have its hands tied with not being able to react? Something has to be done … how else can we get very dangerous drugs off the market in a hurry? … and I would agree with Condor … it’s a PRIVILEGE to provide drugs through our system … not a right.
What about giving Homeland Security a power like this rather than the FDA … then you would avoid potential conflict of interest and any bio-terror drug could be pulled immediately.
hectormon
As much as I would like the see the power or recall with the FDA, they too, like any other large company can be influenced by politics.. their own.
If I can recall the case of Chiron, who manufactured Fluviron, with all the issues the company had (warning letter worthy), they were still going to be able to release the product with additional testing. This was going to be allowed until our friends over the pond pulled their license in the UK. Only then was the FDA pressured into pulling there license here and the lots were destroyed, along with the company, which was purchased by Novartis and the manufacturing was moved.
Had the FDA had the power of recall then, would they have used it? Seems the answer was No then, so I do not know how that would change.
In addition, the traditional good old boys club of the FDA continues. Once an inspector leaves the FDA, they can become an independent consultant or work for a pharma/biologic/biotech/device. I am very aware of inspections where “issues” were commented on rather than documented because “person x” was Ex-FDA. Similar to the Chiron case, would that continue?
M. Black
Patrons:
To your comment regarding a spin off to other policy matters, how environmental policy? In their truest of forms, they both should be one in the same.
Even judgemental windbags would agree to that.
And you?
~ M. Black
patrons99
M. Black - with the current Apocalypse in the Gulf, it’s become clear that the world is getting much smaller. The environment IS fragile. Current events show that there is much less room for policy mistakes, both environmental policy and global health policy mistakes. We think are making “correct” policy choices. What if our policy choice are based upon a “shakey” foundation? The conflict between xenobiotic and natural health can be likened to two worlds about to collide. We think that we understand the secret of life so well now, that we are prepared to give Pharma, BIO, and iBIO, carte blanche to do whatever they choose.
http://www.saynotogmos.org/dna_myth.html
http://www.s3support.com/members/scientific/publications/rationale.cfm
http://www.i-sis.org.uk/FSAopenmeeting.php
Sincerely, Judgmental Windbag