Reminder: Administrative Record is Due in K-V v. FDA on 8/29/2012

08/09/2012		MINUTE ORDER granting 20 Motion for Extension of Time to File Administrative Record. Defendants are ORDERED to submit the administrative record on or before August 29, 2012. Signed by Judge Amy Berman Jackson on 8/9/12. (DMK) (Entered: 08/09/2012)
08/09/2012		Set/Reset Deadline: The Administrative Record is now due by 8/29/2012. (jth) (Entered: 08/09/2012)

K-V Pharmaceutical Use of Cash Collateral Approved by U. S. Bankruptcy Court

Follows Agreement Between the Company and Its Senior Note Holders Regarding Cash Collateral

St. Louis, MO, August 8, 2012 – K-V Pharmaceutical Company (“K-V” or “the Company”) today announced that all “First Day” motions presented to the U.S. Bankruptcy Court on August 7, 2012 that were included as part of the Company’s initial filings in its voluntary reorganization cases were approved on either an interim or final basis by the U. S. Bankruptcy Court for the Southern District of New York, the Honorable Judge Allan L. Gropper presiding.

"Together with the Court’s prior approval of our First Day motions, this authorization of the use of cash collateral is another important step forward, further ensuring that K-V is able to continue operations and focus on the restructuring process," said Greg Divis, President and CEO of K-V Pharmaceutical. “Meanwhile, reaching agreement regarding this matter with our Senior Noteholders sets the stage for continued cooperation toward the development of a plan of restructuring under which K-V will be able to emerge from chapter 11 as a stable and competitive company,” Divis concluded.

To read the remainder of the press release, click here.

KV Pharmaceutical delays release of Q1 results

From the St. Louis Business Journal by Greta Weiderman, Web Editor

Date: Friday, August 10, 2012, 9:26am CDT

KV Pharmaceutical will be filing results for its first fiscal quarter ended June 30 late.  KV Pharmaceutical Co. will be filing results for its first fiscal quarter ended June 30 late since it filed for Chapter 11 bankruptcy on Aug. 4.  To read the remainder of the article, click here.

K-V Complaint Against State of South Carolina

Click here to view complaint.

K-V Complaint Filed Against State of Georgia

Click here to view complaint.

U.S. Bankruptcy Court Approves K-V Pharmaceutical "First Day" Motions

To read the article, click here.

K-V v. Keck-State of South Carolina Docket: List of Dockets Filed So Far

K-V Pharmaceutical Company et al v. Keck, Assigned to: Chief Judge Margaret B Seymour
Cause: 42:1396 - Tort Negligence

Note you cannot click on any of the links and view the documents without setting up a Pacer account and paying for the documents. As I have time, I will post some of the main documents on the blog. 

Date Filed	#	Docket Text
07/25/2012	1	COMPLAINT against Anthony Keck ( Filing fee $ 350 receipt number 0420-4206208.), filed by Ther-Rx Corporation, K-V Pharmaceutical Company. (Attachments: # 1 Exhibit Index, # 2Exhibit 1 - FDA Questions and Answers, # 3 Exhibit 2 - FDA Statement on Makena, # 4 Exhibit 3 - FY2012 FDA Budget Request, # 5 Exhibit 4 - FDA Statement on Makena, # 6 Exhibit 5 - FDA Updated Statement on Compounded Versions, # 7 Exhibit 6 - CMS, # 8 Exhibit 7 - SCDHHS Medicaid Bulletin, # 9 Exhibit 8 - email from Anthony Keck to Joseph Auci, # 10 Exhibit 9 - Magellan Medicaid Administration)(mdea ) (Entered: 07/26/2012)
07/25/2012	4	Local Rule 26.01 Answers to Interrogatories by K-V Pharmaceutical Company, Ther-Rx Corporation.(mdea ) (Entered: 07/26/2012)
07/25/2012	5	Summons Issued as to Anthony Keck. (mdea ) (Entered: 07/26/2012)
07/26/2012	6	MOTION for Preliminary Injunction by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. (Attachments: # 1 Memo in Support Plaintiff's Memorandum in Support of Motion for Preliminary Injunction, # 2 Exhibit A - Declaration of Michael Jozwiakowski, # 3 Exhibit List to Declaration of Michael Jozwiakowski (Exhibit A), # 4Exhibit A-1 - March of Dimes, Prematurity Campaign, The Economic and Societal Costs, # 5 Exhibit A-2 - March of Dimes, Neonatal Death, # 6 Exhibit A-3 - March of Dimes, Born Too Soon, # 7 Exhibit A-4 - Estimated Effect of 17 Alpha-Hydroxyprogesterone Caproate on Preterm Birth in the United States, # 8 Exhibit A-5 - Letter from John McCormick to Catherine Williams, # 9Exhibit A-6 - Letter from Julie Beitz to Robb Hesley, # 10 Exhibit A-7 - U.S. Food & Drug Administration, Review by the Division of Reproductive & Urologic Products, # 11 Exhibit A-8 - Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate, # 12 Exhibit A-9 - Letter from Paul Meis to Whom it May Concern, # 13 Exhibit A-10 - Follow-up of Children Exposed to Utero to 17 [alpha]-hydroxyprogesterone Caproate Compared with Placebo, # 14 Exhibit A-11 - Use of Progesterone to Reduce Preterm Birth, Nov. 2003, # 15 Exhibit A-12 - Use of Progesterone to Reduce Preterm Birth, Oct. 2008, # 16 Exhibit A-13 - Compounding Problems and Compounding Confusion, Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split, # 17 Exhibit A-14 - Report, Limited FDA Survey of Compounded Drug Products, # 18 Exhibit A-15 - 2006 Limited FDA Survey of Compounded Drug Products, #19 Exhibit A-16 - Compounded Drug Testing Report (2009), # 20 Exhibit A-17 - Investigation of Product Quality Between Extemporaneously Compounded Progesterone Vaginal Suppositories and a Approved Progresterone Vaginal Gel, # 21 Exhibit A-18 - Pathway to Global Product Safety and Quality, # 22 Exhibit A-19 - Media Briefing on Heparin (2008), # 23 Exhibit A-20 - Melanine Contamination in China (2009), # 24 Exhibit A-21 - Drug Safety, FDA Has Conducted More Foreign Inspections and Begun to Improve its Information on Foreign Establishments, but More Progess is Needed (2010), # 25 Exhibit A-22 - Testimony of Randall W. Lutter, Ph.D. (Mar. 7, 2007), # 26 Exhibit A-23 - U.S. Food and Drug Administration, FDA Statement on Makena (Nov. 8, 2011), # 27 Exhibit A-24 - Press Release, KV Pharmaceutical Company, Independent Laboratory Testing Demonstrates Important Quality Differences Between FDA-Approved Makena and Compounded 17P Formations, # 28 Exhibit A-25 - FDA, Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 29 Exhibit A-26 - Centers for Medicare and Medicaid Services, Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 30 Exhibit A-27 - FDA, Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena))Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) Modified on 7/26/2012 to edit text (mdea, ). Modified on 7/26/2012 to reflect additional attachments filed as entries 7 , 8 and 9 (mdea, ). (Entered: 07/26/2012)
07/26/2012	7	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Thomas McHugh (Exhibit B). (Attachments: # 1 Exhibit List to Declaration of Thomas McHugh (Exhibit B), # 2 Exhibit B-1 - 2003 NIH Study re Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate, # 3 Exhibit B-2 - 2007 NIH Study re Follow-up of Children Exposed in Utero to 17 alpha-hydroxyprogesterone Caproate Compared with Placebo, # 4 Exhibit B-3 - Agreement between the NICHD Maternal-Fetal Medicine Units Network and Adeza Biomedical Corporation regarding 17-hydroxyprogesterone caproate, # 5 Exhibit B-4 - Feb. 3, 2011 Letter from Julie Beitz, FDA, Office of Drug Evaluation III, to Robb Hesley, Hologic, Inc., re Accelerated Approval for NDA 021945, # 6 Exhibit B-5 - Feb. 10, 2011 Letter from R. Hesley, Hologic, to S. Monroe, FDA, # 7 Exhibit B-6 - KV Form 8-K (March 8, 2011), # 8 Exhibit B-7 - March 30, 2011 FDA Statement, # 9 Exhibit B-8 - March 30, 2011 CMS Statement, # 10 Exhibit B-9 - Medicaid Bulletin issued by the SCDHHS, # 11 Exhibit B-10 - SCDHHSs July 3, 2012 interpretation of its policy, # 12 Exhibit B-11 - Magellan Medicaid Administration Drug Lookup, # 13 Exhibit B-12 - CMS June 15, 2012 Informational Bulletin, # 14Exhibit B-13 - FDAs June 15, 2012 Press Release, # 15 Exhibit B-14 - FDAs June 29, 2012 Question and Answer document, # 16 Exhibit B-15 - KV Form 10-K for the year ending March 31, 2012 (relevant pages))(Willis, Marguerite) (Entered: 07/26/2012)
07/26/2012	8	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Scott Goedeke (Exhibit C). (Attachments: # 1 Exhibit List to Declaration of Scott Goedeke (Exhibit C), # 2 Exhibit C-1 - Feb. 3, 2011 Letter from Julie Beitz, FDA, Office of Drug Evaluation III, to Robb Hesley, Hologic, Inc., # 3 Exhibit C-2 - Ther-Rxs Medicaid Drug Rebate Agreement, # 4 Exhibit C-3 - US FDA, Review by the Division of Reproductive & Urologic Products, NDA 21-945, 17a-Alpha Hydroxyprogesterone Caproate at 9 (Aug. 2, 2006), # 5 Exhibit C-4 - Zsakeba T. Henderson, et al., Attitudes and Practices Regarding Use of Progesterone to Prevent Preterm Births, Am. J. Perinatology 529, 532 (2009), # 6 Exhibit C-5 - Joanna E. Adamczak, et al., What prevents eligible patients from receiving 17-alpha-hydroxyprogesterone caproate therapy, Am. J. of Obstetrics & Gynecology (Jan. 2011), # 7 Exhibit C-6 -March C-6 - March 2011 testimony of FDA Commissioner Margaret Hamburg1 testimony of FDA Commissioner Margaret Hamburgny, # 8 Exhibit C-7 - FDAs Nov. 8, 2011 Press Release, # 9 Exhibit C-8 - FDAs June 15, 2012 Press Release, # 10 Exhibit C-9 - FDA, Questions and Answers on Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena), # 11 Exhibit C-10 - CMS Release No. 155, # 12 Exhibit C-11 - CMS Release No. 158, # 13 Exhibit C-12 - CMS June 15, 2012 Press Release, # 14 Exhibit C-13 - Feb. 20, 2012 KV Letter to Mr. Keck, # 15 Exhibit C-14 - March 22, 2012 Keck Letter to KV, # 16 Exhibit C-15 - July 3, 2012 email exchange between Mr. Auci and Mr. Keck, # 17 Exhibit C-16 - Correspondence to SCDHHS by Providers in SC who would like to prescribe Makena to their Medicaid patients)(Willis, Marguerite) (Entered: 07/26/2012)
07/26/2012	9	Additional Attachments to Main Document 6 MOTION for Preliminary Injunction Declaration of Dr. Lawrence Robillard (Exhibit D). (Willis, Marguerite) (Entered: 07/26/2012)
07/27/2012	10	SUMMONS Returned Executed by Ther-Rx Corporation, K-V Pharmaceutical Company. Anthony Keck served on 7/26/2012, answer due 8/16/2012. (Attachments: # 1 Affidavit of Personal Service on Anthony Keck)(Willis, Marguerite) (Entered: 07/27/2012)
07/27/2012	11	AFFIDAVIT of Service for Motion for Preliminary Injunction, Memorandum in Support of Motion for Preliminary Injunction served on Byron Roberts on 07/27/2012, filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Affidavit of Personal Service on Byron Roberts)(Willis, Marguerite) (Entered: 07/27/2012)
07/27/2012	12	MOTION to Appear Pro Hac Vice by Margaret Donahue Hall ( Filing fee $ 250 receipt number 0420-4210779) by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) additional attachment entry 15 added on 7/30/2012 (asni, ). addtional attachment entry 19 added on 8/2/2012 (asni, ). (Entered: 07/27/2012)
07/27/2012	13	MOTION to Appear Pro Hac Vice by Drew William Marrocco ( Filing fee $ 250 receipt number 0420-4210820) by K-V Pharmaceutical Company, Ther-Rx Corporation. Response to Motion due by 8/13/2012. Proposed order is being emailed to chambers with copy to opposing counsel.(Willis, Marguerite) (Entered: 07/27/2012)
07/30/2012	15	Additional Attachments to Main Document 12 MOTION to Appear Pro Hac Vice by Margaret Donahue Hall ( Filing fee $ 250 receipt number 0420-4210779) Certificate of Good Standing. (Willis, Marguerite) (Entered: 07/30/2012)
07/30/2012	16	AFFIDAVIT of Service for Motion for Preliminary Injunction, and Plaintiffs' Memorandum in Support of Motion for Preliminary Injunction served on Brenda James on behalf of Anthony Keck on July 26, 2012, filed by K-V Pharmaceutical Company, Ther-Rx Corporation. (Attachments: # 1 Affidavit of Personal Service on Anthony Keck)(Willis, Marguerite) (Entered: 07/30/2012)
07/31/2012	17	TEXT ORDER granting 13 Motion to Appear Pro Hac Vice Signed by Chief Judge Margaret B Seymour on 7/31/2012.(asni, ) (Entered: 07/31/2012)
08/01/2012	18	NOTICE of Hearing on Motion 6 MOTION for Preliminary Injunction : Motion Hearing set for 8/28/2012 03:00 PM in Columbia # 3, Matthew J. Perry Court House, 901 Richland St, Columbia before Chief Judge Margaret B Seymour. Plaintiff is responsible for notifying defendant of hearing.(mdea ) (Entered: 08/01/2012)
08/02/2012	19	Additional Attachments to Main Document 12 Motion to Appear Pro Hac Vice for Margaret Donahue Hall. (Willis, Marguerite) (Entered: 08/02/2012)
08/02/2012	20	TEXT ORDER granting 12 Motion to Appear Pro Hac Vice for Margaret Donahue Hall Signed by Chief Judge Margaret B Seymour on 8/2/2012.(asni, ) (Entered: 08/02/2012)

Judge Amy Berman Jackson Takes FDA's Motion to Dismiss Under Advisement after Hearing

8/07/2012

Minute Entry for Proceedings held before Judge Amy Berman Jackson: Motion Hearing held on 8/7/2012 re: 6 MOTION to Dismiss filed by Defendants' UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL., The 6 Motion to Dismiss was Heard and Taken Under Advisement. (Court Reporter Kellie Humiston) (jth) (Entered: 08/07/2012)

K-V Pharmaceutical Files for Bankruptcy Protection

To read the article in Bloomberg Business week written by David E. Rovella on August 04, 2012, click here.

KV Pharma CEO Gets Hefty Raise, Despite All The Problems

Ed Silverman, Contributor, For Forbes Magagzine, has written an article entitled, KV Pharma CEO Gets Hefty Raise, Despite All The Problems. To read this article click here.

SC to fight lawsuit over pre-term birth drug

By: Robert Kittle | WSPA-TV
Published: August 01, 2012 Updated: August 01, 2012 - 10:12 PM

» Comments | Post a Comment

COLUMBIA, SC -- South Carolina's Department of Health and Human Services is vowing to fight a lawsuit filed against it by a pharmaceutical company. K-V Pharmaceutical has also filed separate lawsuits against Georgia and the U.S. Food and Drug Administration.
Regardless of the outcome it will cost state taxpayers money, either in the cost of defending the lawsuit or in added Medicaid costs. A spokesman for DHHS says the agency doesn't have an estimate for how much the lawsuit may cost.
The lawsuit is about a drug given to pregnant women to prevent pre-term births. Since 2005, South Carolina has been using a generic version of the drug known as 17P. It's actually a hormone, hydroxyprogesterone caproate.
According to DHHS, "The use of compounded 17P is accepted by doctors as a safe and effective therapy to fight prematurity, and since 2005 SCDHHS has worked closely with physicians statewide to make it readily available to women at risk of pre-term births. SCDHHS, the March of Dimes, the SC Chapter of the American College of Obstetrics and Gynecology and the South Carolina Hospital Association are working together through the statewide Birth Outcomes Initiative to actively promote the use of 17P."
But K-V Pharmaceutical is suing, arguing that South Carolina and Georgia should be using only its version of the drug, named Makena. In a release, the company says, "In certain states, Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition - despite the clinical judgment made by many healthcare providers that FDA-approved Makena® is the appropriate choice for their patients, and despite FDA’s repeated statements that Makena® offers greater assurance of safety and effectiveness than compounded 17P formulations."

To continue reading article click here.

K-V v. FDA Amici Brief Filed By Alere Women's and Children Health, LLC and Interested Physicians

To view the brief filed by amici curiae Alere Women's and Children Health, LLC and Interested Physicians in K-V vs. FDA, click here.
To view exhibit 1 to brief filed by amici curiae, click here.
To view appendix 1 to brief filed by amici curaie, click here.
To view appendix 2 to brief filed by amici curiae, click here.
To view appendix 3 to brief filed by amici curiae, click here.
To view K-V's response to brief filed by amici curiae, click here.

Motion to Dismiss and Memorandum in Support filed by FDA in case filed by K-V

To view the motion to dismiss, click here.
To view the memorandum in support of the motion to dismiss, click here.
To view exhibit 1 to memorandum in support of the motion to dismiss, click here.
To view exhibit 2 to memorandum in support of the motion to dismiss, click here.
To view exhibit 3 to memorandum in support of the motion to dismiss, click here.
To view exhibit 4 to memorandum in support of the motion to dismiss, click here.
To view exhibit 5 to memorandum in support of the motion to dismiss, click here.
To view the proposed order to the motion to dismiss, click here.

Additional Deadlines in K-V Litigation

07/10/2012		MINUTE ORDER denying 5 Motion for Order Requiring Defendants to File Administrative Record by July 20, 2012. Upon consideration of plaintiffs' motion and the matters discussed at the conference call on this date, it is ORDERED that defendants file the Administrative Record in this action on or before August 10, 2012. Signed by Judge Amy Berman Jackson on 7/10/12. (lcabj1) Modified on 7/10/2012 to reflect that this is a Minute Order (jth). (Entered: 07/10/2012)
07/10/2012		Minute Entry for proceedings held before Judge Amy Berman Jackson: Telephone Conference held in Chambers on 7/10/2012. (NO REPORTER PRESENT) (jth) (Entered: 07/10/2012)
07/10/2012		Set/Reset Deadlines: Defendants to file the Administrative Record by 8/10/2012. (jth) (Entered: 07/10/2012)

To see first post with deadlines, click here

K-V May Need to Win Lawsuit to Avoid Bankruptcy

Bleeding cash, K-V sues FDA

by Ben Fidler And Jamie Mason  |  Published July 12, 2012 at 10:18 AM

Pharmaceutical companies typically lean on positive feedback from the Food and Drug Administration for survival. K-V Pharmaceutical Co., on the other hand, will have to win a legal war against it to avoid a stay in bankruptcy.

Read more: Bleeding cash, K-V sues FDA - The Deal Pipeline(SAMPLE CONTENT: NEED AN ID?) http://www.thedeal.com/content/restructuring/bleeding-cash-k-v-sues-fda.php#share#ixzz20RAy96my

Investors can Continue to Bring Claims Against KV Pharmaceutical

An interesting blog post entitled, Investors can Continue to Bring Claims Against KV Pharmaceutical, can be found here.  This blog discusses the United States Eighth Circuit Court of Appeals ruling that investors can continue to bring claims against KV Pharmaceutical Co. (KV) for making false or misleading statements to the U.S. Food and Drug Administration (FDA). The 8th Circuit issued its decision on  June 4, 2012.  The decision can be viewed here.  Investors claim they suffered $1.5 billion in losses because KV misled the FDA in its compliance reports, and subsequently shut down its manufacturing operations in 2009.

In March 2010, former KV subsidiary Ethex Corp pleaded guilty to two-felony counts of criminal fraud and agreed to pay $27.6 million in fines and restitution. In 2011,  KV's former chief executive, Marc Hermelin, pleaded guilty to misdemeanor violations of the Food, Drug and Cosmetic Act and was sentenced to 30 days in jail and ordered to pay $1.9 million in fines and forfeitures.

Complaint Filed in K-V v. FDA, case number 12-01105

The Complaint filed in K-V Pharmaceuticals v.  FDA  can be viewed here.
The Motion for Temporary Restraining Order and Preliminary Injunction can be viewed here.
Exhibits to the complaint can be viewed here.
The declaration of Scott Goedeke can be viewed here.
The declaration of Michael Jowiakowsk can be viewed here.
The declaration of Thomas McHugh can be viewed here.
The declaration of Patrick Ronan can be viewed here.
The proposed order for the temporary restraining order can be viewed here.
The proposed order for the permanent injunction can be viewed here.

Deadlines in K-V v. FDA

                On July 5, 2012, the district court entered a minute order, setting the following deadlines:

MINUTE ORDER. Based on the matters discussed with counsel for the parties at a telephone conference held on this date, it is ORDERED that pursuant to Fed. R. Civ. P. 65(a)(2), the motion for temporary restraining order and preliminary injunction [Dkt. # 2] will be consolidated with the merits. It is FURTHER ORDERED that the matter will be briefed in accordance with the following schedule: defendants' dispositive motion and combined memorandum in opposition to plaintiffs' motion and in support of its dispositive motion shall be filed on or before July 20, 2012; plaintiffs' combined reply and opposition to the dispositive motion shall be filed on or before July 27, 2012; defendants' reply in support of its dispositive motion shall be filed on or before August 3, 2012; and a motions hearing is set for August 7, 2012, at 2:00 pm. Since plaintiffs' motion is now consolidated with the merits, the parties need not brief irreparable harm. Signed by Judge Amy Berman Jackson on 7/5/12. 

On July 6, 2012, the district court entered the following additional deadlines:

Set/Reset Deadlines/Hearings: Defendants' Dispositive Motion and Opposition to Plaintiffs' motion is due by 7/20/2012; Plaintiffs' combined Reply and Opposition to Defendants' Dispositive Cross Motion is due by 7/27/2012; Defendants' Reply in support of its Dispositive Cross Motion is due by 8/3/2012; Motions Hearing scheduled for 8/7/2012 at 2:00 PM in Courtroom 3 before Judge Amy Berman Jackson.

K-V sues FDA over Makena in fight for survival

Thu Jul 5, 2012 6:59pm EDT

* Focus on cheaper versions of preterm birth drug Makena * K-V says FDA favored cost over science, safety
* Says will go bankrupt in 3-6 months without FDA action
* FDA has said compounded versions pose no risk
By Anna Yukhananov
WASHINGTON, July 5 (Reuters) - K-V Pharmaceutical Co is suing the U.S. Food and Drug Administration for not cracking down on compounded versions of its premature birth drug Makena, in a last-ditch fight for the company's survival.
Makena is an injectable hormonal medicine that reduces the risk of pre-term birth in women who have already delivered early in the past. K-V got approval to sell Makena last year, giving it a new lease on life after it was barred from making and marketing its own drugs due to repeated manufacturing problems.
But pharmacies had already been compounding a similar, and far cheaper, drug for years for people who had a prescription from a doctor. They use the active ingredient hydroxyprogesterone that has been available on the market without formal FDA clearance.
In its lawsuit, K-V said the FDA was addressing the financial concerns of insurance companies that cover the cost of medications instead of the needs of patients in declining to stop pharmacies from making cheaper versions of the Makena drug. By law, the FDA is only allowed to make decisions based on science, not cost.
K-V said Makena's sales are not enough for the company to satisfy its creditors, and it would go bankrupt within three to six months if the FDA failed to act, according to the lawsuit filed on Thursday in the U.S. District Court for the District of Columbia.
FDA spokeswoman Sarah Clark-Lynn said the agency does not comment on pending litigation.
Shares of K-V closed up 2.2 percent at 65 cents on the New York Stock Exchange, above the 45 cents it hit last week, but still a fraction of its value of over $3 a year ago.

FDA DILEMMA
The FDA normally issues warning letters to distributors of unapproved drugs, or may seize their products.
The FDA recently launched a drive to remove all unapproved drugs from the market due to safety issues, and encouraged companies to apply for formal clearance, but has not taken a hard line against the pre-term birth medications.
Patients and insurers preferred the pharmacy compounds, which cost $10 to $20 per injection versus the $1,500 K-V initially sought to charge for Makena after it was approved in February 2011.
K-V reportedly tried to stop pharmacies from compounding the drug by sending them letters saying they were violating the law and threatening to sue them.
But the FDA said it would take no action against pharmacies that offered the cheaper product, following complaints from U.S. lawmakers and health insurers that K-V was price-gouging for a drug already available on the market. K-V then slashed the price of Makena by 55 percent to $690.
K-V still argued that the older pharmacy compounds were not as safe or effective as Makena, as pharmacies don't need to meet the same manufacturing, safety and efficacy guidelines.
The FDA agreed in November to look into the issue, inspecting 16 samples of the compounded drug and of its active ingredient. In an announcement last month, the health regulator said these versions of Makena posed no major safety risks, though they contained some impurities.
"Although the analysis of this limited sample ... did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products," it said at the time.
The agency also said it was applying its "normal enforcement policies" in declining to stop the compounding pharmacies from making Makena, as it focuses its actions on products that are fraudulent or likely to cause harm.
The case is K-V Pharmaceutical Company v. FDA, U.S. District Court, District of Columbia, No. 12-01105.
New Article can be found here.

FDA Issues More Guidance About Makena®

In the form of Questions and Answers issued on June 29, 2012, the FDA recommends healthcare providers prescribe FDA-approved Makena (hydroxyprogesterone caproate injection) made by K-V  Pharmaceutical Company as the first-line for clinically-indicated patients. The FDA has not determined any other form of progesterone to be effective for this medical condition. The FDA also explained its enforcement policy towards compounded formulations of hydroxyprogesterone caproate. The FDA Questions and Answers state:

The FDA Questions and Answers are as follows: 

What is pharmacy compounding?

The FDA regards pharmacy compounding as the combining or altering of the ingredients of a drug by a licensed pharmacist to produce a drug tailored to an individual patient’s particular medical needs, based on a valid prescription from a licensed medical practitioner. For example, compounding may occur if a patient needs a medication to be produced without a dye or preservative due to an allergy, or needs a medication in a liquid or suppository form because the patient cannot swallow a pill.

Should health care professionals prescribe and patients take the FDA-approved drug product rather than the compounded product?

If there is an FDA-approved drug that is medically appropriate for a patient, the FDA-approved product should be prescribed and used. Makena was approved based on an affirmative showing of safety and efficacy. The company also demonstrated the ability to manufacture a quality product. The pre-market review process included a review of the company’s manufacturing information, such as the source of the API used in the manufacturing of the drug, proposed manufacturing processes, and the firm’s adherence to current good manufacturing practice.
Compounded drugs do not undergo the same premarket review and thus lack an FDA finding of safety and efficacy and lack an FDA finding of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, the FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless 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.

How will a patient know if she is receiving Makena or a compounded product?

A patient can ask her health care provider what product is being administered. A label will also be visible on the vial or syringe with information such as the patient name, prescription number, and name of the product. Typically, if the pharmacy dispenses the FDA-approved product, it will have the brand name “Makena” on the label.

Will the agency take any enforcement action against pharmacies compounding versions of hydroxyprogesterone caproate products?

The FDA may take enforcement action against compounding pharmacies if warranted. The FDA makes its enforcement decisions about compounded products on a case-by-case basis after considering the particular facts at issue. As we explained in the June 15, 2012, statement¹, the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.

Are pharmacies free to compound large volumes of hydroxyprogesterone caproate as long as none of their drugs are tested and found to be unsafe?

No. 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.
The FDA may take enforcement action against pharmacies that compound large volumes of drugs that are essentially copies of commercially available products and for which there does not appear to be a medical need for individual patients to whom the drug is dispensed.

The FDA stated it is using a risk-based approach to enforcement action against compounding pharmacies. The FDA also stated that its investigation did not identify a major safety issue, so does that mean that the FDA does not intend to take enforcement action against the compounders of hydroxyprogesterone caproate?

No. A risk-based approach to enforcement relates to how the FDA generally prioritizes its enforcement efforts. The FDA’s June 15, 2012 statement should not be interpreted to mean that the FDA will take enforcement action only if the agency identifies a particular safety problem. We reiterate that the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding.

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Page Last Updated: 06/29/2012