Woodcock: Drugmakers Are Responsible For Quality
22 CommentsBy Ed Silverman // April 25th, 2008 // 8:28 am
The FDA’s deputy commish told a Senate panel that the increasingly large number of pharmaceutical ingredients manufactured abroad makes it nearly impossible for the agency to ensure the safety of all drugs sold in the US, according to Congressional Quarterly.* “We cannot be the quality-control unit for the world,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee.
While the FDA welcomes additional resources to improve its inspection of foreign manufacturing facilities, additional improvements - such as a better information technology system and a registry of all manufacturers producing products imported into the US - are necessary to help improve efforts to stop contaminated drugs from entering the country, Woodcock said. She also told the panel that manufacturers must assume greater responsibility for the quality of their products, CQ writes.
Senate HELP Chairman Ted Kennedy, the Democrat from Massachusetts, said the FDA needs more resources to monitor products produced overseas, but manufacturers also must use better tests to detect impurities and contaminants in their products, CQ writes. The panel’s ranking Republican, Mike Enzi of Wyoming, said putting more money into inspections would not guarantee safe imports. “The reality of the global economy is that testing every food and drug product from outside the (US) is not currently possible, nor will it every be,” he said
After her testimony, Woodcock reiterated that much of the responsibility for quality products rests with drugmakers themselves. “We’re holding them accountable for their quality system, not being their quality system,” she told reporters. “Any legislative fixes that do not address quality by design will fail.”
*- subscription may be required
James
There is the truth. They cannot protect you. And, truthfully, I don’t believe that if all Americans were taxed at a 100% rate that they would have enough resources to make everything safe–there are just too many food, drug, and medical device producers to ensure it.
They are policemen. They come to a crime scene after the fact, track down the violators, and punish them. They may, on occasion, bumble upon a crime in progress and shut it down. But you have to exercise care and caution when walking alone at night (or, in this case, the drugs that you take and food that you eat).
That’s the reality.
Melody
I believe Woodcock has it right. Place the responsibility for safety where it belongs–on the American corporations who use off-shore facilities, foreign employees and sub-contractors to improve their bottom lines. Currently they have their cake and eat it, too. They shift manufacturing to low-cost countries (costing American jobs), and then claim “they didn’t know” that re-imported products or components were substandard or contaminated. It is THEIR responsibility to KNOW and to provide adequate quality control. The FDA shouldn’t need to or have to inspect foreign plants. They should only have to police American manufacturing facilities. But if an American product is labeled by an American corporation, and sold to Americans, if it is found to be deficient or defective–the FDA should have enforcement “teeth” to exact compliance.
I think the FDA now finds its integrity besmirched by corporate actions that place profits-before-patients. The FDA shouldn’t have to police the world–just do its job and protect American consumers . . . which is NOT synonmous with protecting American corporations.
Laurie
I agree that the FDA cannot assure safety of every single drug, and using that “standard”, preemption is a travesty. If the FDA makes the “we can’t protect you” argument, then liability sits with the manufacturer solely. To free that manufacturer from lawsuit leaves the public with no recourse for a defective drug.
The FDA is saying “We can’t protect you and we’re also going to prevent you from bringing a problem to light”.
Justice in Michigan
Not surprisingly, I agree with Laurie 100%. And, to borrow a phrase from Melody, FDA _cannot_ have its cake and eat it too. If they cannot be the sole institution of accountability, and I agree that they cannot be, then FDA preemption is fully realized as the bankrupt doctrine that it is.
The only counter would be to say that FDA has its own potential enforcement through OCI/DOJ. But, once again, police work is appropriately lowest on FDA’s priority. And they are not going to be able to do it if they don’t really know what’s going on. That is why they have almost always relied on whistleblowers and discovery in lawsuits to find out.
It is too bad that the genuinely responsbile companies, and the great people in all companies, are not enough. But we all know the reality. It only takes a small number of folks, in certain circumstances, to do a lot of hurt.
For those folks, in those circumstances, credible accountability is the only hope we have.
Nathan
JIM and Laurie,
Do you really think that preemption would shelter pharma companies from lawsuits involving medicines that were not manufactured up the standards set by the FDA? I find that hard to believe…
Jack2
Drugs, especially once they go generic, operate like commodities instead of other consumer products. Right now, if you invest in oil futures, or gold futures, or wheat futures then you assume that every given barrel of oil, or ounce of gold, or pound of wheat is identical no matter who made it or where it came from.
That’s how wholesalers treat generic drugs, which results in razor thin profit margins. The ultimate consumer/patient probably doesn’t even know who manufactured the generic drug they just received.
In contrast, when a consumer faces an array of choices for the same product (a car, a toy, a piece of furniture etc), they can decide for themself whether it is worth a bit more money to buy something made by a manufacturer whom the consumer associates with higher quality.
I don’t offer any solutions, or suggestions, or even propose that this system is problematic. I just want to point out that unless this system changes, companies making generic drugs will need to move jobs to the cheapest manufacturing location and produce the cheapest product to stay in business. Likely, oversite will remain lax.
I don’t know if it’s so much profits before patients as Melody describe - I doubt Baxter was breaking the bank on the heparin they made.
Ghost of Warren G. Harding
Hi Nathan - Believe it. FDA preemption means no private litigation, including instances of fraud or whatever form of cover-up.
Such companies _would_ technically be subject to criminal prosecution by the FDA’s own Office of Criminal Investigation which works with the Department of Justice. But, as has been reiterated, actions taken by the COI/DOJ are extremely rare.
In a FOIA I submitted last year, I asked specifically how many times there was OCI prosecution since 1992 (when OCI was created in the wake of the generic drug scandal) for felony fraud, including just the circumstances you mention - covering-up manufacturing defects, as well as other kinds of cover-ups.
The answer is four (4). It is not because there haven’t been plenty of other instances, as also acknowledged to me by FDA. It is because criminal prosecution rarely happens. Instead, there are warning letters, withdrawal of bad batches, remedial plans, settlements, etc.
None of these actions - including successful felony fraud prosecution for covering up manufacturing defects - opens the door to lawsuits. FDA and DOJ are explicit about this point in their amicus brief in the WL v. Kent case.
There _may_ be grounds for suits under the False Claims Act, but these are also extremely rare (Neurontin being the most famous). These are not for damages done to individuals, but to fraud against government agencies (Medicare, Medicaid, etc.). Under such circumstances, the person bringing the action - effectively a whistleblower - gets a share, like a “reward leading to the arrest” kind of thing.
Victims get nothing.
Justice in Michigan
Whoops. I guess I blew my cover. I was temporarily taken over the the Ghost of Warren G. Harding. I am now back as Abe Lincoln.
Laurie
Yup, I do believe this. Preemption is being used in cases today where suppressed data is discovered post FDA approval. How would a manufacturing problem differ from the “if we didn’t know about a problem and approved the drug, then you can’t sue for problems associated with it”?
I don’t see the huge difference in a drug development problem and a manufacturing problem. If there is no FDA standard to be enforced, then the consumer is left with very little recourse for liability. The public would be in a better position if there was no FDA at all and each situation was on a case by case. At least this would take away the “The FDA doesn’t require us to do this, so we’re covered”. It would place the accountability squarely on the manufacturer for it’s practices.
Bottom line is if the FDA can’t police something completely, then the public needs to know this. And if they can’t achieve the standards that the majority of the public holds them to(based on their claims of being the “gold standard”) , they are useless.
Nathan
Don’t manditory childhood vaccines already have a form of preemption? Yet there are still liability lawsuits. It’s just that the federal government pays rather than the company paying. Am I correct?
CMC guy
Woodcock is echoing fundamental cGMP principles however the other reality is that no system ever can reach 100% guarantee. FDA needs to provide consistent guidance and enforcement which they too often have failed to do so in the past (IMO due to inadequate funding). Sponsors need to go back to strong levels of pride and meaning in putting their name on a label (IMO currently dollars > reputation).
I may have missed a mention on this blog but a statement in an USP press release of last week (14th) on Heparin testing development has a very telling lesson on this topic: “According to Roger L. Williams, M.D., USP’s chief executive officer, “It is difficult for analytical procedures to detect and identify all adulterants. USP monographs are designed to test for known impurities that result from manufacture or degradation, not for unknown contaminants that may be added either accidentally or deliberately.”
Although I agree that a Sponsors Quality Systems (again basic cGMP) need to be rigorous and watchful/responsive when dealing with Suppliers/Contactors there are limits to what can be done scientifically and practically, especially in cases of overt sabotage.
I have mixed reaction to preemption debate. I trust lawyers (who always seem to make out well) much less than I do pharma companies so lean to reasonable barriers to proliferation of suits against drug developers who conducted appropriate work to get FDA approval yet unfortunately harmful effects later are uncovered. At the same time if fraud or other malfeasance was used then I think lawyers do have a useful role.
Justice in Michigan
Quick response -
Nathan - yes, there is a modified preemption for about twelve vaccines. However, pts or survivors retain the right to file suit on their own if they do not accept the result of federal review and compensation offer (if any).
Based on Riegel and the Med Device Act, there is now full preemption in the medical device arena. Congress may or may not pass a law that challenges that.
To CMC guy - I am not a huge fan of many lawyers as well. But, of course, there are the lawyers who defend pharma and those who bring suit against them. So it’s lawyer v. lawyer on that level.
In any event, imperfect as it is, I think civil justice and FDA together, as we’ve had for a long time, is better than either one of these very imperfect systems alone.
That’s really the whole preemption ballgame. FDA becomes everything. Civil liability disappears. Not rocket science.
The NYT called preemption “a perverse legal doctrine” in a recent editorial. As I often cite, NEJM described it as having a disastrous impact on patient rights and industry accountability.
Jack2
JIM I have no opinion on preemption.
Frivolous lawsuits raise the price of medications for everyone, clog the court system, and reduce profits. Valid lawsuits help ensure companies act responsibly. I see good and bad to both.
But lots of things have an upside and a downside. I could wear a seat-belt or not wear a seat-belt. In some types of accidents wearing a seat-belt reduces the risk of injury. In other types of accidents, wearing a seat-belt increases your risk of an injury. But the relative risks are no where close to equal - quite simply I’m much more likely to suffer an accident where wearing a seat-belt will help me than hurt me.
We have no idea how much frivolous there are, and how much they cost. We have no idea how much more irresponsibly companies would act if preemption protected them from lawsuits.
So how can I figure out which system is better?
I don’t know a whole lot about how the justice system works. Will we ever get close to fairly guestimating either of those numbers?
Justice in Michigan
Jack 2 - As we’ve discussed before here, the issue is about as politicized as it gets. So there are claims in every direction, figures which are challenged by all sides, etc.. Yes, I have my own view about where the balance of the truth lies. But you know what that is.
Without trying to debate the matter, I will say that we know of only one case, Benedectin for morning sickness, where it appears that lawsuits ended up taking a drug off the market that did not have the risks claimed. That is why preemptors, if you listen to them, constantly invoke it as an example. There simply do not appear to be others.
So I would suggest that may be relevant, along with the well known cases and their outcomes. Along with asking: On balance, how much that was “frivolous” do you really see - both in claims and in results? The “frivolous lawsuit” may have as much reality, in the end, as “evil pharma.” Both ways we demonize without taking the time to analyze.
Finally, there is the difficult cost/benefit analysis of what we _lose_ by taking civil liability out of the picture. We invoke, and rightfully should, rights for _legitimate_ compensation, the issue of accountability, safety data otherwise unrevealed, and so on.
Does the argument for making FDA the sole arbiter really counter-balance all of these? That is the question.
Jack2
You’re much closer to this issue than me JIM. So, while you recognize preemption has both plusses and minuses, in your expert opinion the minuses of preemption exceed the plusses of preemption. Is that a fair statement?
Just A Thought
If you find a restaurant is serving dog meat instead of beef, that restaurant is going to suffer fines, suits, humiliation, and possible closure. Even if they did not know they were buying dog meat.
Why should the pharmaceutical industry have it any better? They are a business just like any other.
If they are sold a bogus excipient, it is the pharmaceutical company’s responsibility to recoup their losses from that supplier. It is not the tax payer’s responsibility.
Insist on fines large enough to make it more cost effective to instill more precautionary systems. Release the lessor product information to the media IMMEDIATELY, and do not allow them to pass the buck. Humiliation is a wonderful deterent.
It is their responsibility to produce their products just as they were when they applied for and gained approval. (The FDA would do good to remember that themselves)
Tossing more money at this protective body is not going to resolve the issue.
Justice in Michigan
To Jack2 - Yes, I feel the minuses of FDA preemption strongly outweigh the plusses, although I do not think I can claim “expert” status - just someone who has been involved for a number of years because of our unique Michigan law (we have had one-state FDA preemption since 1995).
As I’ve said elsewhere, there are numerous other ways to accomplish lawsuit reform, which I think has merits, besides what I view as this “nuclear option” - total destruction. As you will know, some of that has happened already - limits on punitive damages, class action suits, and so on.
I guess it helps not to be a lawyer! If/when “academic reform” happens, I may sound differently!
Sam
I guess I am too much of an old timer concerning the responsibility of drug
quality. Before PHARMA bought 80% of raw drugs from the world, especially
China, they, for the most part manufactured and packaged their own drugs.
At least I thought they did.
In those days, professional journals for pharmacists would note FDA citations
for various manufacturers whose product(s() or plant operations were substandard of FDA criteria. In some cases manufacturing plants were closed until standards of the FDA were met.
If PHARMA was not always compliant with FDA standards before - for what
ever reason (human error, equipment breakdown, etc) how can we make them
completely responsible for the quality of our drugs? We always talk about
over sight committees to ensure quality of product or the waste of money,
therefore the FDA must take an active roll for this responsibility.
Quality assurance is always talked about when people’s lives are concerned whether it be in a hospitals, the food we eat or the cars that we drive. I
would like to to see the import of raw drugs eliminated; give the American
workers jobs and eliminate the need for FDA agents flying to other countries.
CMC guy
JIM I appreciate your comments and admittedly have not fully studied the issue thoroughly as did not think it was as completely FDA vs Civil Liability pendulum as described. Your later responses that end in “Both ways we demonize without taking the time to analyze” is I believe true although would argue in terms of accountability there are limits as to what can be done/expected in drug development just as in quality systems.
Sam I do think PHARMA (like most industries) has slipped from a prevailing attitude to make best and safest product possible if your label is affixed, even if acquired components from overseas (which think has been done for many years although concentration in Far East accelerated in past 20 years). I am in favor of keeping US based manufacturing jobs and lessening burden on FDA inspectors but realities of differential burden costs I do not see willingness of consumers to bear the higher cost it would demand.
Sam
CMC guy- you said - realities of differential burden costs I do not see willingness of consumers to bear the higher cost it would demand.
Don’t you think that if PHARMA stopped spending up to $57 billing in marketing
of which $4.8 billion is spent on direct to consumer ads, plus $2.7 billion
by their lobbyists on member of congress, the price of USA made drugs would
not rise?
My career goes beyond 20 years and my experience goes back to the 60s.
Jack2
This was a generic drug. Baxter doesn’t spend $57 billion on marketing.
CMC guy
Sam I was thinking in terms of Costs of Goods factors as likely to have a direct impact (although aware is often a small percentage overall) that most consumers will not care about.
Even though implication sounds logical I am not sure how not spending/redirecting expenditures on marketing (and lobbyist) would really influence drug prices since sales are on revenue generation side (DTC is a bane IMO but ROI is significant I hear) with connection to price nebulus to me. I have experienced revenues down resulting in reducing R&D spend and layoffs in Manufacturing which may not be linked to prices either but effects long term viability.