A post by Pat

An inexpensive synthetic form of the hormone progesterone was used for decades without FDA approval in hormone replacement therapy and more recently as a drug to reduce the risk of premature delivery. It was custom made inexpensively by compounding pharmacies and sold for around $15 per injection. After winning FDA exclusive approval, KV Pharmaceuticals will now be charging $1,500 per injection. The company never incurred R&D costs. It has not yet performed any clinical trials normally required by the FDA. The company is profiteering from an FDA policy to get rid of unapproved drugs.

FDA Targets Unapproved Drugs

Tackling the problem of unapproved drugs, said Steven K. Galson, director of FDA’s Center for Drug Evaluation and Research, is an “integral” and “important” part of the agency’s mission.

Drugs with unapproved labeling, he said, “may not meet the standards of safety, efficacy, quality, and labeling.”

“Americans expect their drug products to be approved by the FDA,” Galson said. “They don’t want drug products from the dinosaur age of drug regulation. They want products that meet modern standards of safety, efficacy, and manufacturing.”

We certainly shouldn’t be using any drugs the dinosaurs used. Look what happened to them. We don’t really have to go that far back to understand there are dangers with unregulated medicines. It wasn’t so long ago medicine shows traveled around the country selling miracle cures laced with alcohol, opium and cocaine.

Safety, quality and effectiveness standards are desirable. A problem is that the clinical trials to win FDA approval can be very expensive. KV Pharmaceuticals stepped forward to seek FDA approval which they now have. In return the FDA gave the company exclusive rights to manufacture the drug, Makena, by granting orphan drug status. Orphan drug status is an incentive to companies to work on cures for rare diseases. Only a few hundred thousand women a year would potentially benefit from the synthetic hormone for preventing premature deliveries.

Cost of Preterm Labor Preventive Drug Increases From $10 to $1,500

For high-risk pregnant women, a drug to prevent preterm labor may soon be too expensive for many of them to afford.

The drug, Makena, has cost between $10 to $20 in the past. But after KV Pharmaceutical of St. Louis has gained government approval to be the exclusive seller of the drug, the price will shoot up to $1,500 a dose by next week—putting the total cost of injections throughout the course of a pregnancy at $30,000.

Makena is a form of progesterone given as a weekly shot, and in the past was custom produced in pharmacies and was not federally approved.

The FDA has no control over pricing but in this case it made it’s stamp of approval a license to steal.

The total cost of treatment for one pregnancy at $1,500 a shot would be as high as $30,000. The KV chief executive not so kindly pointed out the cost of care for a preemie could be $50,000. In other words, pay me an outrageous sum or pay somebody else even more to save your sick baby.

Preemie outrage: Cost of drug that prevents premature birth to rise from $10 to $1500

Gregory J. Divis Jr, KV Pharmaceutical chief executive said the cost is justified to avoid the estimated $50,000 cost of mental and physical disabilities that can come with very premature births.

…’These moms deserve the opportunity to have the benefits of an FDA-approved Makena.

KV has an FDA granted monopoly on Makena. The FDA doesn’t allow compound pharmacies to make FDA approved drugs. KV already sent out cease-and-desist letters to those pharmacies telling them they could face FDA enforcement actions.

Many people believe this is the way all pharmaceutical companies operate. It is not. KV did not risk anything in R&D. There is a long history of safe use of the drug to build on. It is very inexpensive to manufacture.

KV says it can help out with the costs to patients, but their opportunistic greed is undeniable. Insurance companies will be stuck with the bill.

To add to the outrage, the FDA fast tracked the approval based on a 2003 study financed by the NIH.

FDA’s fast-track approval of Makena could backfire on KV

The Bridgeton-based drug maker won FDA approval last month to exclusively market a brand name version of the drug, which has been sold without approval for years. With its monopoly, KV has raised the drug’s price from about $15 an injection to $1,500.

Makena’s approval rested largely on one study, financed by the National Institutes of Health and published in 2003 by the New England Journal of Medicine. Makena is the commercial version of the drug 17P. The research found that 17P prevented pre-term births in about one-third of the women who received the injections.

Typically, the FDA requires three extensive clinical trials before approving a new drug. But since 1992, the FDA has granted accelerated approval for new cancer drugs and other potentially life-saving medications. The agency approves such drugs under the condition that the applicant can verify its clinical benefit through additional studies and wider market use.

An FDA official said the 2003 study provided enough evidence to approve Makena, even though it showed no direct clinical benefit in preventing infant mortality and disease.

But the FDA is “underfunded and unable to make sure that post-marketing studies get done,” said Efthimios Parasidis, an assistant professor and FDA expert at St. Louis University Law School.

That’s right. KV actually spent nothing on R&D or FDA trials and there is no guarantee the FDA will ever follow up.

The cost of the drug isn’t all that’s gone up. KV’s stock price jumped 131% on Friday. Good news for a company that is coming off a bad stretch. Their former chief is facing criminal charges for failing to notify the FDA that faulty manufacturing of their pain killers resulted in dangerous dosages twice the amount as labeled.

The Big ‘Disaster’ At KV Pharmaceuticals

April 6, 2010

And last month, a wholly owned subsidiary known as Ethex pleaded guilty to two felony counts of criminal fraud for failing to report to the FDA that it was making oversize tablets that could be harmful to patients, The St. Louis Post-Dispatch notes. A KV exec considered what to do in July 2008 after KV discovered oversize tablets and oOne option was “to do nothing because the probability of oversized tablets is very low,” Assistant US Attorney Andrew Lay said in court papers. Over the objections of other employees, the executive chose the “do-nothing option.” The unnamed exec instructed multiple employees to “minimize written communications about KV’s oversized tablet manufacturing problems and limit distribution and discussion of any documents discussing these problems,” according to the prosecutor.

“Bottom line is you just don’t mess with the FDA, and this has happened again and again at KV,” Juli Niemann, an analyst at Smith, Moore & Co., tells the Post-Dispatch. “Trying to take shortcuts for profitability is a systemic problem there.” Adds Lawrence Solow, an analyst at CJS Securities: “It’s a disaster.”

“It’s a disaster,” said Lawrence Solow, an analyst at CJS Securities, a New York brokerage and research firm. “If within six months they don’t start generating revenues, they may end up in bankruptcy.”

Looks like KV found a miracle cure in Makena at the FDA medicine show.

This section is for comments from tammybruce.com's community of registered readers. Please don't assume that Tammy agrees with or endorses any particular comment just because she lets it stand.
5 Comments | Leave a comment
  1. makeshifty says:

    Good post. This illustrates the dangers of regulation. I agree with you that we would not want an unregulated market for drugs. So I’m thinking the answer is to modify the law that created this rule so that if the FDA is going to grant exclusive authority to sell a drug that the privilege be linked to submitting studies that the company has done itself, which substantially advance the existing knowledge about the drug’s effectiveness.

    I realize this is a human interest story, but I’ve seen a similar thing happen in the software field. Several years ago I was hearing about how companies were preferring to use software provided by a name-brand company (think “FDA approved”), as opposed to open source (made by pharmacy). The main argument these companies made had to do with accountability. They felt more assured that they could hold a company accountable for a product that it owned, as opposed to the experience of using a piece of software “floating around” on the internet. They also thought about “motivation to improve” the product according to customer demands. They figured a company would do that, whereas they wouldn’t see that with open source. The commercial products cost more, but many companies still went for them.

    • PatC says:

      Having retired from one of the evil Big Pharms, I have a bit of experience with this and the drug and vaccine approval process. The average cost of investigating and drug trials and submission to FDA or CBER for any one drug is now approximately 1 Billion dollars. The FDA came to the manufacturer and demanded that they now seek approval, after years of successful use in the field. With any drug or vaccine, the only one to receive approval is the one who pays for the studies, as it should be. Government does not pay for the studies, evil corporate pharm companies do; 1 Billion dollars per drug are invested with no guarantee of success. So for every drug approved there are maybe 5 that are not, so that is 6 Billion of investment to get one successful drug.

      Having worked in the industry, writing and directing clinical trials, there were exactly NO projects where only three trials were required. None. There were generally a total of 10 clinical trials, which can take a decade to carry off, and these were preceeded by laboratory studies and studies in animals.

      The FDA approves all plans in advance for trials, known as Clincal Development Plans. They can without warning decide after millions have been invested in a CDP, that no, perhaps they should have demanded studies be done in a different fashion.

      Sooooo, think about why suddenly the Obama administration is hot to get control of drugs that have been in use for years, and where marketed before current standards were developed.

      Enlarging the criteria for drug studies enlarges the bureacracy of the FDA and thus creates more government dependent voters. Taking the creation of compounds facility away from pharmacists in hospitals and neighborhood pharmacies, decomposes the profession of pharmacy. It seems that the Obama administration lackeys are out to destroy the profession of the Pharmacist, much like they are out to destroy the profession of the physician.

      If we are to now say, that the person who invests the money in a project, must share the proceeds, then who in heavens name would invest? FDA is demanding larger and larger clinical trials, which drives up the cost of development. In addition, a 6 Billion dollar investment must be recouped in a 7 year period, when the patent runs out. THIS is why drugs cost so much.

  2. Slimfemme says:

    I am not a friend of the FDA. In fact, I think that they are a hindrance to life and limb. If I am an individual that is facing a terminal illness I should not be beholden to a bureaucracy arbitrary approval for drugs. Can you imagine how many drugs have not been developed or scrapped all together because of this monstrosity? This is the kind of moral hazard that we face with government interference.

  3. Maynard says:

    We’re darned lucky Obama steamrolled the nation and gave us Obamacare, so the government will buy us all those drugs that policy has rendered unaffordable. And now we’ll get our drugs for free, which is even better than paying $15 (assuming the Washington bureaucrat in charge agrees that we need them). A system where you could buy drugs for $15, when some people don’t have $15, isn’t fair, is it? And if the government actually outlaws a few of the drugs or turns down our requests for others, I’m sure they have a darned good reason.

You must be logged in to post a comment.