DVV

Don't you realize that there are some docs that simply want use Makena but can't because of the price and the fact that most Medicaid programs and the majority of insurance plans either place Makena in Tier 3 or do not pay for the drug. (Tier 3 is the highest co-pay, which eliminates many patients because of inability to pay for the drug).

I don't know what you mean by "...lust for their past", since I only have interest in seeing that the only FDA approved drug for premature fetal delivery is available to patients at a reasonable cost. Currently the price of Makena is outrageous, considering that the compounded alternative of Makena is much cheaper and has been around and used since the early 1990's. I'd like to use Makena on my patients, but I am forced to use the compounded alternative because of how the 3rd party payers do reimbursement and develop co-pays. It seems to me that TherRx is interfering with the use of Makena by keeping the price so high.

 

Can you explain to the good people of this board what happened between Marc and the FDA in the early 1990's? Was KV not shut down for manufaturing issues? Marc tried to alter batch records for Metorporol ER in the attempt to get around the particle size issue with the new process that Esteve was running with API (vs previous process filed with official ANDA application). David never lived up to Daddy's standards, and David hated Marc for divorce from his mother - that's why he didn't get the job. Just admit you are a grandson/granddaughter/illegitimate child of Marc OR David and save yourself the embarrasment. Marc manipulated his Father into giving the company over to him.

You are a tool. Stop with the everything was fine until DVV. IT WASN'T!

 

Poster you are completely wrong. Your statements are totally false. Are you using this board for other reasons? The facts are DVV was a failure and he used his failure to overthrow Marc thinking he could partner with the FDA after his take over. DVV was the reason KV let go 1200 employees. Regarding David was actually very competent and he was well respected in the organization. Time for you to move on or state the facts.

 

I guess DVV and some of his prodrones are on here posting away. For those of us that were part of DVV's pharmaceutical division we know it was his incompetence that sparked to the burn down of the company. DVV, Rita, and some of the other stooges knew they had failed so they called the FDA when they screwed everything up. From the minute the came into the company they did absolutely nothing but complain.

 

Don't duck the question - what happened to KV in the 90's? Who was in charge, and were the warning letter issues ever resolved. All facts of public record. No other reason for posts except to counter your revisionist history. Learn to think for yourself, instead of listening to your family

 

Please don't post any family rhetoric until you explain this? Who was in charge?

KV PHARMACEUTICAL PRODUCTS SEIZED BY FDA INCLUDE ALL SOLID- DOSE OTCs

By The Tan Sheet / View Full Issue
Word Count: 638 / Article # 05010090011 / Posted: April 26 1993 5:00 AM

Executive Summary

KV PHARMACEUTICAL PRODUCTS SEIZED BY FDA INCLUDE ALL SOLID- DOSE OTCs, the agency said. Due to KV's noncompliance with good manufacturing practices, investigators from FDA's local branch office seized all solid-dose OTC and prescription products that were "on hand" at the company's St. Louis facility on April 21, including final dosage forms and in-process materials. The OTC products seized include phenylpropanolamine, buffered aspirin, enteric coated aspirin and antacid tablets; OTC vitamins are not among the confiscated products. Prescription products represent most of finished dosage forms seized, FDA said. The agency estimated the value of all the seized drugs at about $ 15 mil. FDA noted that KV has three options in response to the seizure: accept the seizure, contest the appropriateness of the action or enter into a consent decree. FDA investigators and a U.S. marshall entered KV's manufacturing facilities on April 21 with a seizure order based on a complaint filed by the agency in St. Louis district court on April 20. FDA said it asked the U.S. Attorney's office to seal the complaint in order to ensure that the seizure would proceed quickly and efficiently. However, while the complaint is sealed, the agency cannot disclose the specifics of KV's GMP problems. The government has filed a motion to make the complaint public on April 26. FDA pointed out that over the last year it has conducted several inspections at KV that unearthed GMP violations that the firm subsequently failed to adequately address. The most recent inspection spanned from mid-February to March 17. The resulting FD-483 observes that "neither biobatch data nor clinical batch data was provided or reviewed that justifies the commercial manufacturing process and specifications for" drugs marketed under ANDAs or drug master files including nitroglycerin ER caps and theophylline immediate-release caps. In 1992, there were at least two major inspections at KV: July 31-Nov. 3 and March 11-April 23. Also, four prior inspections -- in May-June 1990, March-April 1991, May 1991, and August-September 1991 -- found that "deficiencies existed between the production of the biobatches and the full-scale productions." GMP problems at KV also resulted in at least two recalls of Rx drug products in 1992. The issue of whether recalls will occur following the April 21 seizure will be discussed when the agency meets with KV, FDA said. In addition, a January 1992 FDA warning letter to the firm foreshadowed continuing compliance problems at the company. "You have a practice of correcting the specific deficiencies addressed by the investigators relating to a specific product but you do not follow through in correcting the deficiencies throughout the 'system' to cover all products," the warning letter asserts. St. Louis-based KV Pharmaceutical specializes in drug delivery technology and has a number of arrangements with major pharmaceutical firms to develop and manufacture products using its extended-release technologies. For example, KV's once-a-day oral technology, KV/24, is incorporated in Hismanal-D, which is a combination of Janssen's once-a-day antihistamine and KV's once- daily pseudoephedrine decongestant. Hismanal-D is pending approval at FDA; the combination product is currently marketed outside the U.S. KV also contract manufactures drugs and has product development arrangements with firms including Warner-Lambert. Through its Ethex subsidiary, KV also markets specialty generic products to wholesalers and drug store chains. Separately, generic manufacturer Circa (formerly called Bolar Pharmaceutical) paid $ 3 mil. to KV to settle a suit filed by KV in St. Louis federal court in February 1990. KV had sought $ 149 mil. in damages and terminated the firms' joint venture, citing Bolar's "impaired . . . reputation and trade prestige" due to a FDA audit of Bolar's ANDAs and related "substantial adverse publicity." Since the lawsuit was filed, the Justice Department has successfully prosecuted most of Bolar's former top management team for participating in a scheme to submit fraudulent data to FDA to support generic drug approvals.

 

Some truth in what you say, but most is untrue or overstated. The major point that you miss is that DVV caused the issues (in cahoots with some others in KV) that resulted in the FDA shutting down KV in 2009. Marc took responsibility, as he should as the CEO of the company, but DVV, Rita, and at least two board members, used the FDA issues as a means to get rid of Marc. In so doing, they also caused the shutdown of the company, the recall of all products, and ultimately the loss of some 1700 jobs. DVV, Rita, and some others in the company thought they were whistleblowers that would be rewarded for uncovering and reporting the oversized tablets and failed testing of metroprolol to FDA.... not really appreciating that they were the ones that signed off on the bad drugs.

 

The problems in the early 1990's dealt with mainly documentation issues and needed upgrades for analytical and dissolution equipment At the same time several other pharmaceutical companies were being forced by FDA to quickly institute the new GMP regulations that were promulgated by FDA that dealt with those same issues for which KV was deficient. Within a year, all of the issues were resolved to FDA's satisfaction, and KV was the better for the experience. Those present in management in the early 1990's can attest to the fact that Marc organized the teams that were responsible for the needed upgrades to KV's analytical equipment and operating procedures needed to be in compliance with the new FDA regulations.

What happened in 2009, was a different matter. Incompetent VPs that were given responsibility for the manufacturing areas used improper manufacturing equipment, allowed failed testing in order to release product for sale, and signed off on known problems such as oversize tablets. The very incompetent VPs and some board members had a vision of KV without Marc or Sarah, and orchestrated a "palace coup" in order to get rid of Marc/Sarah. The plan backfired when they contacted FDA since FDA considered the violations to be serious enough to shutdown the company and order all products recalled. DVV was the major signatory for the bad drugs release. Marc, as CEO, to his credit, did take responsibility for his VPs action.

These are the facts. Regarding what happened in 1990, perhaps the news articles of the day in the 1990s didn't address how quickly and efficiently Marc and the company righted itself. But, the fact is the company did correct all of the FDA issues at the time and did so with haste.

 

DVV, Rita, and the "others" were incompetent fools that are the sole source of failure at KV. The previous poster is very accurate.

 

Let's not forget this gem. Let me guess - the incompetent VP's and scandalous board members decided to make and ship unappoved products after the company was told to stop. Would love to hear your spin on this one.

Truth - Marc saw a market monopoly play when all other companies complied with the FDA request to leave the market, then Corp Communications came up with a play to call it all a "misunderstanding of the rule".

Federal Agents Seize more than $24 Million in Unapproved New Drugs
Products made after the FDA required an end to production

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

"American consumers are entitled to have safe and effective drugs," said Hanaway.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

PhenaVent Capsules
PhenaVent LA Capsules
PhenaVent PED Capsules
Ethezyme Papain-Urea Ointment
Ethezyme 650 Papain-Urea Ointment
Ethezyme 830 Papain-Urea Ointment
Hista-Vent DA Tablets
Meperidine/Promethazine Capsules
Pseudovent Capsules
Pseudovent 400 Capsules
Pseudovent PED Capsules
Tri-Vent DM Syrup
Tri-Vent DPC Syrup
Hydro-Tussin DM Liquid
Hydro-Tussin CBX Syrup
Hydro-Tussin DHC Syrup
Hydro- Tussin EXP Syrup
Hydro-Tussin HD Syrup
Hyoscyamine Sulfate Sublingual Tablets
Hydroquinone 4% Cream
Hydroquinone 4% Cream with Sunscreen
Bromfenex Extended Release Capsules
Bromfenex PD Extended Release Capsules
The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm

 

You will note that the FDA notice was published in June of 2006, and the FDA action on KV was in May of 2007. Not a lot of time for KV to adjust to the FDA action.... in the past FDA allowed several years for pharma companies to abide by new regulations in which serious, life threatening, stuff was not likely. In the 2007 timeframe, FDA came down on many pharma companies for the same issues, with no or little lead time allowed to implement the changes.

So, the action that you have quoted, while truthful and correct, was not a very serious happening at KV. It was FDA exerting its power over many companies like KV that were manufacturing and selling "grandfathered" drug products that never went through the FDA approval process.

Later, in 2009, KV did commit several criminal acts, which brought down the company. Marc was blamed for this happening too, but the decisions that caused the issues were made by his VPs at the time (discussed elsewhere on this board).

 

Who has time for this?

 

It's a two minute google search. Someone is showing their age

 

Love how you gloss over the obvious. This shows a record of having a "above everyone else" attitude at KV for 20+ years. It was a big deal at the time, and your wrong that it took other companies a while to abide by the pronouncement to stop manufacturing unapproved products.
More simple google searches completely discredit your argument. Do you have anything more than "true, but" arguments. You continue to provide zero facts.

 

Victor Hermelin, the 93-year-old founder of KV Pharmaceutical Co., has gone to court to try to have his son Marc Hermelin, president of KV, removed as a trustee of one of four trusts set up to benefit Victor Hermelin's five children and his ex-wife.
In his lawsuit filed March 1 in St. Louis County Probate Court, the elder Hermelin charges that Marc Hermelin, 64, has managed a $35 million trust to favor himself and selected relatives and has a conflict of interest in his dual roles as company president and trustee.
"Marc Hermelin has acted at all times in an effort to continue to control voting power of KV and keep the trust stock tightly held to his control. Marc Hermelin has administered the trust for his own benefit in order to do so," Victor Hermelin said in the suit.
The lawsuit gives a rare glimpse inside the Hermelin family, whose patriarch launched KV in 1942 and later received patents for controlled-release and other drug-related technologies. The scientist helped build KV into a public company with $367 million in revenue and more than 1,000 area employees.
Sibling rivalry

Victor Hermelin set up four irrevocable trusts worth a combined $260 million to benefit his family, according to the lawsuit. Beneficiaries of the $35 million trust in question are Victor Hermelin's former wife, Minnette Hermelin, 91, who receives net income from the trust during her lifetime; Victor Hermelin's three children from his first marriage -- Marc and Arnold Hermelin and Anne Kirschner; and his current wife's two daughters, Cindy Miano and Dawn Walters, whom he adopted in 2005.
According to the suit, Marc Hermelin initially congratulated his father about the adoptions. But later, after learning about the effect on the trust, "expressed his indignation toward Victor in a series of letters."
Victor Hermelin has had a father-daughter relationship with Miano and Walters for 25 years, according to the suit. The sisters are named as plaintiffs in the suit along with Victor Hermelin.
The suit states Victor Hermelin is concerned that if the trust is not changed, "upon his death, his natural son Marc Hermelin will take the position that Cindy Miano and Dawn Walters are not beneficiaries and Victor Hermelin will not be alive to testify in his behalf as to his intent."
Marc Hermelin previously asked his father, Miano and Walters to sign documents waiving all their rights in the trust in question, as well as other rights in all four trusts, "in exchange for a minimal amount of money chosen by Marc Hermelin himself," according to the suit, which does not say what the amount was.
When Victor Hermelin declined to sign the document, Marc Hermelin threatened prolonged litigation, the suit claims.
The suit also reveals alleged disputes between Marc Hermelin and his natural sister, Anne Kirschner, 56, who is represented by attorneys Barry Short, Albert Rose and Robert Will of Lewis, Rice & Fingersh. The suit states Marc Hermelin threatened to retaliate against Kirschner if she withdrew permissible funds from her trust, which is worth more than $70 million. She did so, and within weeks her husband, Mitch Kirschner, was fired from KV after 30 years of service, the suit states. Mitch Kirschner was KV's vice president of new business development until Jan. 20, 2006.
Victor Hermelin said the suit will have more impact on his children than his business and referred questions to his estate attorney, Richard Bender of Rosenblum, Goldenhersh, Silverstein & Zafft. Bender said his client filed suit to protect the interest of his adopted daughters. Marc Hermelin did not return telephone messages left at his office. His attorney Tom Corbett of Thompson Coburn declined to comment.
Conflict of interest

The suit alleges that Marc Hermelin has a conflict of interest in acting as CEO of KV Pharmaceutical and trustee of the trust: "Victor Hermelin believes, that over a thirty-year period, these conflicts have risen to a level that is no longer acceptable."
The Hermelin family, through the family trusts, controls about 13 percent of KV's Class A shares and 62 percent of Class B shares, according to filings with the Securities and Exchange Commission. Both classes of stock trade for about the same price -- currently about $26 a share -- but Class A shares have one-20th the voting power of Class B shares.
Lawrence Brody, an estate lawyer with Bryan Cave, and Marc's son David Hermelin also serve as trustees of the trust in question and are named in the suit. David Hermelin is also a KV executive.
The $35 million trust could generate

$1 million or more a year "if conservatively and prudently invested," but it has been generating substantially less, constituting "breaches of fiduciary duty by the trustees," the suit said.
The suit also alleges that Marc Hermelin has made distributions to his mother that exceed the trust's income.
The suit claims Marc Hermelin distributed $157,568 to his mother in December 2004, when the trust income was $21,050, and distributed $191,068 to her between July and December 2005, when the trust had income of $41,000. The actions violated trust terms to the detriment of other beneficiaries, the suit said.
Victor Hermelin also asked the court to state specifically that Walters and Miano are beneficiaries and to require Marc Hermelin to repay trust property the suit alleges Marc distributed prematurely to his mother.
The suit also states that the court could terminate the trust without harm to any of the beneficiaries. According to the suit, it is "Victor's primary wish that all of his children are able to share in the proceeds of this trust in during (sic) his lifetime without imposing any hardship on Minnette Hermelin." The suit notes that Minnette Hermelin, who receives income from the trust, had already received assets from her divorce from Victor Hermelin of about $35 million. She is represented by attorneys Mark Goodman and Gary Sarachan of Capes, Sokol, Goodman & Sarachan.
The suit emphasizes there is no animosity between Minnette Hermelin and Victor Hermelin and his second wife and adopted children: "They have continued to socialize throughout the last 10 years, including Minnette Hermelin joining Victor Hermelin and his wife Margie Hermelin for their weekly brunch together."

 

There are a lot of people from this company present and past that you can keep writing pages on and they aren't nice stories so move on. We have heard, seen, read, and talked about it all.

 

Let's hear it!!!!!

 

Can you not read or are you just stupid? It says, "move on"!

 

Neither - I just know when I have hit a nerve with someone, and put them in their place. This should end this topic string for good. Leave while you still can, or I will post more truths to counter your lies

 

It's worrisome that you get your "truths" from the newspapers or trade journals (KV retains public relations firms to plant these so called "truths".... you are stupid enough to believe what you have read as being the tell all and know all. Fact of the matter is that the history of KV is much more complicated than you have been led to believe).

The craziness of the Hermelin family notwithstanding, Marc was unfairly burdened with the sole responsibility for the criminal actions of the company in 2008/2009 whilst the real responsible parties got off without any repercussions. The VP of Manufacturing and VP of QA signed off on the bad drugs to allow them to be sold.... they are the true criminals. That same VP of Manufacturing was made CEO after FDA shut-down the company. That same VP of manufacturing received a $1 Million severance package when it finally realized how incompetent he really was.