Latest KV BK Coming

K-V says it will go bankrupt without FDA intervention

Agency's lack of action on Makena, compounds K-V's financial troubles


July 6, 2012 | By Eric Palmer

K-V Pharmaceutical ($KV.A) claims in a lawsuit that if the FDA does not allow it to exclusively make the premature birth drug Makena and charge 35 times more per injection than compounders, its business is kaput.

In a lawsuit filed Thursday against the FDA, K-V says without the protection it will be bankrupt in three to 6 months, reports Reuters.

Makena is a hormone that is injected to lower the risk of premature birth in women who have had babies prematurely in the past. The company and the agency have been circling each other for months over the drug, which women have traditionally gotten for $10 to $20 per injection in compounded form, compared with the $1,500 K-V initially wanted to charge when the FDA approved its version in February 2011. It dropped the price to $695, a 55% cut, after charges that it was price gouging.

The agency has publicly declared that the approved version is preferable, but left the compounds on the market. When K-V complained that they may not provide safe, effective and consistent treatment, the FDA tested a bunch of them and decided that in fact they did. Insurers have naturally sided with compounders and the FDA on the matter.

The K-V legal complaint contends FDA does not have the authority to rule on drugs based on price, only on science, and that the science shows an FDA approved drug is better than one that is unapproved. The agency declined to comment about the lawsuit.

K-V claims of being on the ropes is not just legal hyperbole. The company has been in trouble for years after the feds discovered it had covered up manufacturing problems and fined it $25.8 million. Its former CEO was sent to jail and the company is facing a $1.5 billion lawsuit claiming it hid problems from shareholders as well. Unable to make the drugs it previously manufactured, it sees Makena as its last hope against a premature demise.

- here is the Reuters story

The FDA has to be laughing out loud on this request. What idiot thought it would be a good idea to ask the FDA to help KV? This is hysterical. I'm sure the FDA will be working overtime to help the company charging 40X more for a product already available that is proven to be safe and effective on the market today. Who is making these decisions?

Layoffs coming for the entire company in the next few weeks.

This place is so done. I'm double dipping and taking Therx for all its worth.

The FDA should hurry up and close down this execuse of a pharmaceutical company. The BOD should clean house and then throw out everyone in the office and throw away the keys. This company is done and over.

Way to go Greg. Why did you wait to sue the FDA? This should've been done two years ago. Before we all get fired the BOD should take Divis and fire his ass.

Originally Posted by Anonymous

Way to go Greg. Why did you wait to sue the FDA? This should've been done two years ago. Before we all get fired the BOD should take Divis and fire his ass.

I seriously doubt Divis is losing any sleep behind any of this. Afterall, he has made a ceo's salary for the past several years and should be pretty set. The sales reps on the other hand...

It is a real shame.
Shame on you Divis! And the Board!
Snatching defeat from the jaws of victory.
Shameless.

Only shame here is the bulk of you wannabe reps.
I'd say the win HUGE with the FDA, settlement and crackdown with 17 puke, business takes off and they fire half you geeks

Originally Posted by Anonymous

Only shame here is the bulk of you wannabe reps.
I'd say the win HUGE with the FDA, settlement and crackdown with 17 puke, business takes off and they fire half you geeks

The real shame is seeing a moron from the yahoo board coming here on cafepharma making stupid comments (hint: I am talking about you). Do you really think it will help boost the stock? Get real. You bought a turd of a stock and the money is running out. Kiss your $$$ goodbye.

K-V Pharmaceutical orders a beer in last-chance saloon
Source EP Vantage
Company K-V Pharmaceutical Company, Hologic
Tags Comment, Free Content, Corporate Relations, Fines & Regulatory Issues, Litigation, USA, Genito-Urinary
Date July 10, 2012
When K-V Pharmaceutical, maker of the premature birth drug Makena whose price is at the centre of a storm in the US, decided last week to sue the FDA it probably thought it had no friends left to lose.
Still, when you consider that the company made a $102m net loss on sales of just $23m last year, and has $132m of debt falling due in the next 12 months, you can start to understand its desperation. With K-V capitalised at $27m but carrying a massive $552m of total debt, it seems that little short of a miracle can prevent it from going out of business.
K-V’s spat with the US regulator concerns what the company contends to be the agency’s failure to crack down on pharmacies that have been selling compounded versions of Makena at a fraction of the drug’s cost. The FDA denies not taking enforcement action, but says it will only act on a case-by-case basis – something K-V contends is at odds with its long-standing stance of prohibiting compounded drugs when FDA-approved versions exist.
On June 15 the agency revealed findings from its own studies showing that compounded Makena falls largely within potency guidelines, without major safety problems. As if there had been any doubt, this was seen as a green light for compounding.
Anomalous development
Development of Makena was unusual from the start. The drug went through the NDA procedure while relying on an investigator-sponsored study, and is basically a version of Delalutin, a premature birth preventive first approved in the 1950s but now withdrawn.
The fact Makena was given seven years of orphan drug exclusivity just added to the anomaly. This exclusivity provides the only barrier to a direct competitor, so perhaps K-V has a right to feel aggrieved that the FDA’s purported inaction has effectively allowed the Orphan Drug Act to be circumvented.
Trouble is, K-V lost the battle for the moral high ground a long time ago. Its hugely misguided pricing strategy for Makena caused any support it might have had to fall away, and turned the issue of access to safe medicines into a politically charged argument about corporate greed.
It was the fact that Makena, launched in March 2011, came with the shockingly high price tag of $1,500 per injection that compounding became an issue at all. Insurers saw little need to shell out for the drug when compounded versions cost a mere $10 or so. After an outcry K-V agreed to lower the list price to $690 the following month, but the damage had already been done.
March of Dimes, a US charity working to reduce infant mortality, severed its ties with K-V, which had been a significant sponsor. The charity, which had called for a significant reduction to the $1,500 price, says $690 is still too high. “There is not enough patient access,” a spokesperson told EP Vantage.
Averting bankruptcy
Analysts at Imperial Capital believe that current Makena patient take-up translates into some $38.5m of annual sales – a level that K-V must at least triple “to avert a bankruptcy”. They speculate that slashing Makena’s price to $200 would generate $123.6m of revenue at 40% market penetration.
A K-V spokesperson said the company had worked with payors to create a pricing structure to ensure access to Makena. He also pointed out that the company had found that the active ingredient used by compounding pharmacists most often came from unregistered manufacturing facilities in China.
The FDA told EP Vantage that it would not comment on ongoing litigation.
In the meantime, Imperial Capital believes K-V must try to renegotiate upcoming licensing payments to Hologic, Makena’s originator, which represent a large near-term liability. This might help delay the cash crunch, as might cutting operating costs. “We do not understand why K-V is conducting a [long-term] Makena clinical trial,” they wrote in a June 27 note. The trial is not due to report until 2016.
Just how much headroom there is for further price reductions, and whether these might do anything to change the FDA’s stance, are two key issues with which the company must now grapple, assuming that it is not already too late. To be sure the grim reaper is now knocking at K-V’s door.

Saturday, July 7, 2012
FDA's Mermaid Problem
By Michael McCaughan / Email the Author

The Makena controversy is moving to court, and likely to a very unhappy ending for KV Pharma. But FDA’s decidedly unusual communications about compounding in the midst of that controversy may have longer term implications.

On June 27, the National Oceanic and Atmospheric Administration issued a seemingly unnecessary notice on its website: There is no such thing as a mermaid. Actually, NOAA wasn’t that blunt about it: the headline stuck to the facts—“No evidence of aquatic humanoids has ever been found.”

That's right: the federal government officially denies the existence of human fish half-breeds.

The denial was prompted by questions NOAA received in response to a documentary on the Discovery Channel, NOAA explained to Reuters. The documentary apparently suggested some sort of NOAA cover-up in play.

Still, we can't help suspecting that NOAA’s denial may have backfired. Count us among those who never considered that there might be evidence of “aquatic humanoids.” And, while the statement is in fact a beautifully crafted brief reflection on the mermaid legend, it probably didn’t ease anyone’s confusion about the difference between fantasy and reality. After all, anyone who even knows what NOAA is already knows mermaids are a creature of myth. On the other hand, if you believe in mermaids, you aren't likely to believe NOAA.

FDA may have a mermaid problem of its own.

In this case, the half-breed is very real: compounded medicines. These products look and feel like FDA approved medicines, but they aren’t. At least not entirely—the active ingredient often is FDA approved, but the formulation is created (or modified) by a pharmacist into something that isn’t FDA regulated. For consumers, these medicines don’t even seem special in any way. They are prescribed by a doctor and dispensed by a pharmacy. They come in the same vial as FDA approved medicines. But they aren't FDA approved. Mermaid medicines, if you will.

Unlike NOAA, FDA doesn’t need to deny the existence of these mermaids. Rather, the agency is trying to explain when and how they are allowed to survive—and in particular, how it is possible for one particular product, hydroxyprogesterone, to exist simultaneously in an FDA approved formulation and in pharmacy compounded versions that are supposed to be identical.

In this case, FDA isn’t responding to questions about a documentary but rather to questions about the distinctly odd circumstance surrounding Makena, KV Pharma’s now-notorious FDA-approved formulation of the pre-term labor drug. That ingredient was previously available solely via pharmacy compounding—and, much to KV’s chagrin—remains widely available via that route.

And just like NOAA, the agency recently resorted to stating the obvious: “FDA emphasizes that it is applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone acetate,” the agency declared in a June 15 statement. In other words, the policy is the policy.

Somehow we suspect that plenty of people will doubt it is as simple as that.

In part, that’s because FDA’s “policy” on compounded drugs is very hard to articulate.

Everyone would agree that some pharmacy compounding is legal, appropriate and necessary: there are individual patient needs that can only be met by pharmacists practicing their trade and preparing a compound that is right for that patient. And everyone would agree that some “compounding” is in fact nothing more than an illegal manufacturing operation: FDA regulation would be meaningless if any pharmacist in America can buy a barrel of bulk active ingredient and resell it to as many customers as they can find.

But that leaves a lot of gray area in between, where some might see a trigger for FDA regulation while others might see the practice of pharmacy.

And those mermaids have been driving the agency crazy for a good long time now. When compounding leads to patient harm, FDA takes the blame. But when FDA cracks down on compounding, it hears about it from pharmacies and their allies in Congress—and, in a key ruling in the 1990s, from the Supreme Court.

FDA has since articulated a policy (see here) that it thinks it can defend. And that policy stresses, in part, that routine, full-scale compounding of FDA-approved products isn’t generally appropriate.

But FDA has articulated a policy of sorts, and it stresses in part that it will consider enforcement action when a pharmacy is “compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products.”

Which brings us to Makena. The back story is long, but the key point is that just about everyone balked at the price set by KV: approximately $1,500 per weekly injection, compared to about $50 for the pharmacy compounded version everyone was using before. (KV has since sharply cut Makena’s price, but it is still much more expensive than the unapproved versions.)

KV isn’t the first company to attract unwanted feedback due to its pricing, and it won’t be the last. But it may be the first to go out of business because the market rebelled so completely. At least, KV says it is six months away from bankruptcy—and that is why it is suing FDA for failing to help it make the Makena price stick.

FDA, to put it mildly, hasn’t exactly helped KV out so far. When the Makena controversy flared up at the launch of the product in early 2011, FDA issued a most unusual statement, declaring that “under certain conditions, a licensed pharmacist may compound a drug using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient.”

“In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products,” FDA declared.

In November, FDA issued a new statement, reiterating the key point of the first one, but then adding that it has received information about the “variability in the purity and potency” of compounded hydroxyprogesterone and that it was investigating further. “Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product.”

The agency reported the results of its review on June 15. In summary, the review suggested that KV was right – there is variability in the purity and potency of compounded products. However, the agency added, it “did not identify any major safety problems.” On the other hand, FDA did NOT repeat its early statement about not intending to take enforcement action. That is where it declared that it is “applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone.”

The agency even issued a follow-up Q&A underscoring that “The FDA does not consider compounding large volumes of copies, or what are essentially copies, of any approved commercially-available drug to fall within the scope of traditional pharmacy practice. One factor that the agency considers in determining whether a drug may be compounded is whether the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.”

What FDA didn’t do was start cracking down on compounders.

We suspect KV will struggle to win litigation forcing FDA to take an enforcement action; in fact, we’re pretty sure there isn’t a court in the land that will go that far – at least not in the timeframe KV says it needs to stay afloat.

Mermaids don’t exist, and soon KV may not either.

Saturday, July 7, 2012
FDA's Mermaid Problem
By Michael McCaughan / Email the Author

The Makena controversy is moving to court, and likely to a very unhappy ending for KV Pharma. But FDA’s decidedly unusual communications about compounding in the midst of that controversy may have longer term implications.

On June 27, the National Oceanic and Atmospheric Administration issued a seemingly unnecessary notice on its website: There is no such thing as a mermaid. Actually, NOAA wasn’t that blunt about it: the headline stuck to the facts—“No evidence of aquatic humanoids has ever been found.”

That's right: the federal government officially denies the existence of human fish half-breeds.

The denial was prompted by questions NOAA received in response to a documentary on the Discovery Channel, NOAA explained to Reuters. The documentary apparently suggested some sort of NOAA cover-up in play.

Still, we can't help suspecting that NOAA’s denial may have backfired. Count us among those who never considered that there might be evidence of “aquatic humanoids.” And, while the statement is in fact a beautifully crafted brief reflection on the mermaid legend, it probably didn’t ease anyone’s confusion about the difference between fantasy and reality. After all, anyone who even knows what NOAA is already knows mermaids are a creature of myth. On the other hand, if you believe in mermaids, you aren't likely to believe NOAA.

FDA may have a mermaid problem of its own.

In this case, the half-breed is very real: compounded medicines. These products look and feel like FDA approved medicines, but they aren’t. At least not entirely—the active ingredient often is FDA approved, but the formulation is created (or modified) by a pharmacist into something that isn’t FDA regulated. For consumers, these medicines don’t even seem special in any way. They are prescribed by a doctor and dispensed by a pharmacy. They come in the same vial as FDA approved medicines. But they aren't FDA approved. Mermaid medicines, if you will.

Unlike NOAA, FDA doesn’t need to deny the existence of these mermaids. Rather, the agency is trying to explain when and how they are allowed to survive—and in particular, how it is possible for one particular product, hydroxyprogesterone, to exist simultaneously in an FDA approved formulation and in pharmacy compounded versions that are supposed to be identical.

In this case, FDA isn’t responding to questions about a documentary but rather to questions about the distinctly odd circumstance surrounding Makena, KV Pharma’s now-notorious FDA-approved formulation of the pre-term labor drug. That ingredient was previously available solely via pharmacy compounding—and, much to KV’s chagrin—remains widely available via that route.

And just like NOAA, the agency recently resorted to stating the obvious: “FDA emphasizes that it is applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone acetate,” the agency declared in a June 15 statement. In other words, the policy is the policy.

Somehow we suspect that plenty of people will doubt it is as simple as that.

In part, that’s because FDA’s “policy” on compounded drugs is very hard to articulate.

Everyone would agree that some pharmacy compounding is legal, appropriate and necessary: there are individual patient needs that can only be met by pharmacists practicing their trade and preparing a compound that is right for that patient. And everyone would agree that some “compounding” is in fact nothing more than an illegal manufacturing operation: FDA regulation would be meaningless if any pharmacist in America can buy a barrel of bulk active ingredient and resell it to as many customers as they can find.

But that leaves a lot of gray area in between, where some might see a trigger for FDA regulation while others might see the practice of pharmacy.

And those mermaids have been driving the agency crazy for a good long time now. When compounding leads to patient harm, FDA takes the blame. But when FDA cracks down on compounding, it hears about it from pharmacies and their allies in Congress—and, in a key ruling in the 1990s, from the Supreme Court.

FDA has since articulated a policy (see here) that it thinks it can defend. And that policy stresses, in part, that routine, full-scale compounding of FDA-approved products isn’t generally appropriate.

But FDA has articulated a policy of sorts, and it stresses in part that it will consider enforcement action when a pharmacy is “compounding drug products that are commercially available in the marketplace or that are essentially copies of commercially available FDA-approved drug products.”

Which brings us to Makena. The back story is long, but the key point is that just about everyone balked at the price set by KV: approximately $1,500 per weekly injection, compared to about $50 for the pharmacy compounded version everyone was using before. (KV has since sharply cut Makena’s price, but it is still much more expensive than the unapproved versions.)

KV isn’t the first company to attract unwanted feedback due to its pricing, and it won’t be the last. But it may be the first to go out of business because the market rebelled so completely. At least, KV says it is six months away from bankruptcy—and that is why it is suing FDA for failing to help it make the Makena price stick.

FDA, to put it mildly, hasn’t exactly helped KV out so far. When the Makena controversy flared up at the launch of the product in early 2011, FDA issued a most unusual statement, declaring that “under certain conditions, a licensed pharmacist may compound a drug using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient.”

“In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products,” FDA declared.

In November, FDA issued a new statement, reiterating the key point of the first one, but then adding that it has received information about the “variability in the purity and potency” of compounded hydroxyprogesterone and that it was investigating further. “Therefore, as with other approved drugs, greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product.”

The agency reported the results of its review on June 15. In summary, the review suggested that KV was right – there is variability in the purity and potency of compounded products. However, the agency added, it “did not identify any major safety problems.” On the other hand, FDA did NOT repeat its early statement about not intending to take enforcement action. That is where it declared that it is “applying its normal enforcement policies for compounded drugs to compounded hydroxyprogesterone.”

The agency even issued a follow-up Q&A underscoring that “The FDA does not consider compounding large volumes of copies, or what are essentially copies, of any approved commercially-available drug to fall within the scope of traditional pharmacy practice. One factor that the agency considers in determining whether a drug may be compounded is whether the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product.”

What FDA didn’t do was start cracking down on compounders.

We suspect KV will struggle to win litigation forcing FDA to take an enforcement action; in fact, we’re pretty sure there isn’t a court in the land that will go that far – at least not in the timeframe KV says it needs to stay afloat.

Mermaids don’t exist, and soon KV may not either.

Best article explaining the situation to date. It boils down to whether the FDA has a mandatory responsibility to clear out compounders . FDA has always maintained it has discretionary authority. Even if KV wins (by some divine intervention) and the judge orders the FDA to enforce, the FDA will immediately move to stay the decision and appeal. Historically, the appeals court has voted 100% in favor of the FDA as it knows the FDA has the discretion to pursue enforcement. Good luck in bankruptcy KV! The response from the FDA is due this Friday. Shoule be a good read.

The sad truth is this was over before it started. This is the end for KV. Right now the bod and senior leadership are planning how to execute the process to BK or the end. Most likely a first wave reduction in the very near term that takes out the sales team and non essential people. Leaves a small team mostly made up of the senior management team that will navigate thru BK. The plan was probably already proposed and now they are finalizing for implementation.

Who will they keep? Probably the whole marketing team. What a laugh.

Originally Posted by Anonymous

Who will they keep? Probably the whole marketing team. What a laugh.

Of course you go after the marketing team, trader to SG but you stick up for others that would stab your on blood...go figure...She was right about you...loser...

Makena is indicated: ".....to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth." That means a compounder can still make the product for women that have no history of preterm birth or don't have a singleton pregnancy. There is no way FDA can close down the competition. It would mean denying women outside our indication treatment or allowing us to sell off label.

Originally Posted by Anonymous

Who will they keep? Probably the whole marketing team. What a laugh.

I just hope that they eliminate positions starting from the bottom up so that they can keep paying SG and GD, as well as the Board for making all the "smart" decisions.

Originally Posted by Anonymous

I just hope that they eliminate positions starting from the bottom up so that they can keep paying SG and GD, as well as the Board for making all the "smart" decisions.

This company was in trouble long before this latest shamble. SG and GD are far to blame. The problems go way back, way back. They should have sold off after the first meltdown. People were greedy and selfish and thought only of themself and a few others they cared about everyone didn't matter. If you weren't part of the "inner circle" you were trash. (yet that trash was the ones taking care of everything, making all the money for the company, holding it all together) The big guys thinking they knew it all, yet we knew more then they realized. Maybe if SG and GD were running things and got rid of the "trash" none of this would have happened back in the day.

Blah blah blah. Please get a new story. You've posted this stuff before. So you weren't invited to the inner circle and that really hurt your feelings. Get over it already. Look SG and GD had plenty of time to get this right. They failed. Blaming the inner circle of the past for todays failures is just a whiny excuse. GD and SG had the best chance to save the company with Makena and they screwed it up.

Originally Posted by Anonymous

This company was in trouble long before this latest shamble. SG and GD are far to blame. The problems go way back, way back. They should have sold off after the first meltdown. People were greedy and selfish and thought only of themself and a few others they cared about everyone didn't matter. If you weren't part of the "inner circle" you were trash. (yet that trash was the ones taking care of everything, making all the money for the company, holding it all together) The big guys thinking they knew it all, yet we knew more then they realized. Maybe if SG and GD were running things and got rid of the "trash" none of this would have happened back in the day.

I agree that you should be running things, Scott. You could have saved e company.

Signed,

Your Mom

Originally Posted by Anonymous

I agree that you should be running things, Scott. You could have saved e company.

Signed,

Your Mom

C17P imprts good enough for pregnant moms but drugs that are used in leathal injections on death row inmates are very important and the FDA has banned them from coming from outside the US? Seem odd or not really?

CDCR

Sodium thiopental is one of three drugs used in California's lethal injection procedure.

The Federal District Court in Washington D.C. today ruled that execution drugs obtained by U.S. prisons from foreign suppliers are illegal and will have to be returned to the Food and Drug Administration.

A number of states purchased sodium thiopental–an anesthetic used in lethal injections–from a company in the United Kingdom amidst a U.S. shortage of the drug in 2010. California is among those states, having bought 514.5 grams, in theory, enough for 171 executions.


In February last year, a group of death row inmates in Arizona filed suit in federal court to stop the use of the foreign-made drug in executions nationwide. The major issue for the inmates is whether the drugs, which had not been approved by the FDA, would work properly if used in an execution. Sodium thiopental is traditionally the first drug in a three-drug lethal injection cocktail. An anesthetic, the drug is supposed to prevent the condemned inmate from feeling pain while dying. A second drug paralyzes the inmate, and a third stops his or her heart. A lethal dose of sodium thiopental is also sometimes used as the sole drug in an execution.

Today, U.S. District Judge Richard Leon took the inmates’ side, admonishing the FDA for allowing states to import unapproved drugs.

Two of the Arizona inmates involved in the suit have already been executed.

Federal law says that a drug may not be imported to the United States unless it’s listed with the FDA. “The FDA’s actions are clearly inconsistent with its own regulations,” Leon wrote. “The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner’s needle. How utterly disappointing!”

Leon went on to order the FDA to require states with sodium thiopental obtained from foreign sources to return the drug to the agency.

A spokesman for the California Department of Corrections and Rehabilitation today said the department’s legal team is reviewing the ruling. Executions are on hold in the state, as several challenges to the state’s lethal injection procedure work through federal and state courts. Meanwhile, a proposed ballot initiative that would replace capital punishment with life in prison will likely go before voters in November.

States have continued to look to alternative drugs and foreign sources of sodium thiopental since Hospira, the sole FDA-approved manufacturer of sodium thiopental stopped making the drug in 2011, citing the company’s opposition to the drug’s use in executions.

you are comparing an orange with an apple.

imported 17p is the active not the finished product whereas this case is imported finished product.
95% of API's are imported and if they have a monograph it is perfectly legal.

Originally Posted by Anonymous

you are comparing an orange with an apple.

imported 17p is the active not the finished product whereas this case is imported finished product.
95% of API's are imported and if they have a monograph it is perfectly legal.

Interpreted as a true idiot. Bottom line more money wasted on "dead Man Walking" than on saving an unborn, you missed the key point, FDA stopped this, and its for the bottom feeders of the earth(like you)