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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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November 9, 2011

KV Pharmaceutical's Latest Makena Move

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Posted by Derek

Remember the Makena story from earlier this year? That's the progesterone ester whose price was raised (and how) after FDA approval by its manufacturer, KV Pharmaceuticals. (Here's the whole history). When last heard from, the FDA had sent out a letter to compounding pharmacies who were providing the drug at lower cost, saying that they were not intending to take action against them (an unusual move, to be sure).

Now KV has made their next move. According to this FDA statement, the company has provided the agency with data on a number of samples of the drug, claiming variable purity and potency in the compounded products. The FDA is looking over KV's data, and is conducting their own investigation into this as well. For now, they're reminding people that "greater assurance of safety and effectiveness is generally provided by the approved product than by a compounded product". But they're not taking any more action, for now. We'll probably be hearing more about this. . .

Comments (14) + TrackBacks (0) | Category: Regulatory Affairs


COMMENTS

1. anonymous on November 9, 2011 9:42 AM writes...

chuckle to myself that I would grind up spices and the like with a mortar and pestle in the kitchen with my kids helping out. We went to a local chain store pharmacy to pick up a script when my youngest saw the same thing on the shelf behind the counter and asked the pharmacist what they used their mortar and pestle for. The young lady gave us a blank stare. She had no clue what it was called or used for.

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2. anon 1 on November 9, 2011 10:10 AM writes...

Under the circumstances and their remit, what else can FDA really do? Great business strategy here, even as the ultimate consumer and insurance companies take the financial hit....

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3. SteveM on November 9, 2011 11:18 AM writes...

The simple solution is not hyper-expensive Makena, it's standardizing the compounding process.

How hard could it be for the 17P manufacturer to create a YouTube video instructional for pharmacists? They could even collect new compounded samples after video training from the same pharmacies Makena bought compounded product from.

This is a process problem that could be resolved one way or another in a couple of weeks.

Reading about this kind of stupid bureaucratic log-rolling drives me nuts.

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4. SteveM on November 9, 2011 11:19 AM writes...

The simple solution is not hyper-expensive Makena, it's standardizing the compounding process.

How hard could it be for the 17P manufacturer to create a YouTube video instructional for pharmacists? They could even collect new compounded samples after video training from the same pharmacies Makena bought compounded product from.

This is a process problem that could be resolved one way or another in a couple of weeks.

Reading about this kind of stupid bureaucratic log-rolling drives me nuts.

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5. Edward Taussig on November 9, 2011 11:54 AM writes...

@SteveM
"The simple solution is not hyper-expensive Makena, it's standardizing the compounding process."

Heck, why don't we just get all our drugs compounded? Who needs safety standards and site inspections? Hell, we'll know if the stuff is bad if people die, we don't need the government to spend money testing it and inspecting factories.

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6. Pharmacist on November 9, 2011 11:56 AM writes...

@SteveM: You honestly think in Pharmacy school pharmacists are not trained to compound sterile products and a youtube video would help them out?

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7. SteveM on November 9, 2011 12:31 PM writes...

Re: Pharmacist

Acknowledge your expertise. So the question is still a process one. What are the factors that most contribute to 17P compounding variability? And can a standardized procedure be put in place to minimize product variability?

That should be a relatively simple process analysis. It ain't rocket science. Why isn't someone doing the analysis, standardizing the process and posting the "Best Practice" compounding solution?

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8. Edward Taussig on November 9, 2011 12:49 PM writes...

@teveM
"So the question is still a process one."

No, actually it's not just a process question, if you look at the report KV submitted to the FDA, it's just as much about the source of the supplies,
i.e. contamination and variation, if you start with crap, you'll end up with crap no matter how you compound it.

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9. SteveM on November 9, 2011 1:10 PM writes...

Re: Edward Taussig

Then the root cause is the supply claim. Which is still a process problem. Buy only from suppliers with tight specs. Contract out to specific suppliers. Whatever...

My main point is that these barriers can be surmounted with some intelligent process design and contracting.

Again, it ain't rocket science.

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10. Edward Taussig on November 9, 2011 2:57 PM writes...

@SteveM

No, the root of the problem is trust - without an enforcement process, there can be no trust.
You say 'Buy only from suppliers with tight specs' - and who is to enforce that? How is the patient to know who is buying from good suppliers and who isn't? Without better regulation and enforcement of the entire compounding process, it's a crapshoot.

Compounding still has a place, but when there is an approved drug on the market, the bar should be set much higher to allow compounding of that drug given all the risks that compounding entails.

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11. Anonymous on November 9, 2011 4:09 PM writes...

# 10

Correct, some drugs MUST be compounded (including many chemo drugs.) I'll never forget once seeing a pharmacist lugging this white, obviously very heavy cylinder-with-handle out of a locked vault. He put on an extra apron (lead-lined I later found out) and started mixing. It looked like something out of the Manhattan Project.

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12. Wjheels17 on November 10, 2011 3:07 PM writes...

These people are pretty dense. Now, they sell only a few doses at huge prices. So, while their profit per unit is large, their total profit is small. Sell it closer to the compounding price and it's not worth it to compound at the pharmacy. Plus, the patient doesn't have the risks associated with the competency of the pharmacist. That should be worth 2 or 3x the compounding price.

2400 patients at $1485 is $3.5 million gross profit. 140,000 patients at $45 per patient is $4.2 million gross profit. Somewhere in between is the sweet spot on profit, significantly above the current level.

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13. molecular architect on November 14, 2011 11:46 AM writes...

An off-topic post:

"it ain't rocket science."

My least favorite expression when applied to Pharmaceutical research. Used to have an MBA boss say this when projects had issues. One day, I blew up and explained to the dolt that "rocket science" ain't science, it's engineering.

While engineering of any kind isn't always easy, an engineer always starts with the fact that, given sufficient resources, the job can be done. With Pharmaceutical R&D, you don't know if the condition/disease can be treated with a drug until the clinical trials are over.

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14. Ed on November 18, 2011 10:05 AM writes...

Everyone seems to be ignoring the fact that a ton of money was spent to get approval of Makena and the plant will face ongoing inspections so every step in the process is going to have to be done right. Otherwise the plant is shut down. Individual pharmacies have none of this expense or supervision. Of course a pharmacy can sell much cheaper. Anyone that things all pharmacists are equal in honesty, conscientiousness, etc and therefore can be blindly trusted for equal quality can contact me immediately for a great deal on the purchase of the Brooklyn bridge.

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