Thursday, November 14, 2019

Why the DEA is suing Colorado’s pharmacy board as part of an opioid investigation State officials say they can’t release the data the DEA wants without violating patients’ privacy


https://coloradosun.com/2019/11/11/dea-subpoena-opioid-pharmacy-board/

Judge: DEA had no evidence to support pharmacy suspension By Erin Beck The Register-Herald 12 hrs ago

https://www.montgomery-herald.com/news/judge-dea-had-no-evidence-to-support-pharmacy-suspension/article_86815356-067f-11ea-ae1f-074c584e9137.html
6 days ago - The pharmacy, Valisure, is a start-up with only 14 full-time employees. But since its scientists alerted American regulators that Zantac and its generic form,
1 day ago - A sampling of levothyroxine (LT4) liquid formulations obtained from compounding pharmacies and student pharmacists using state-of-the-art equipment, show
2 days ago - Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the 
Foley Hoag LLP
Back in May, we wrote about substantial settlements totaling $125 million to resolve Department of Justice (DOJ) allegations that money donated by Astellas Pharma US, Inc. and Amgen Inc. to drug co-pay charities constituted illegal kickbacks under the False Claims Act (FCA).
Foley Hoag LLP
The chief executive of a Boston-based biotech company, Frank Reynolds, was convicted of defrauding investors and obstructing an SEC investigation. Reynolds founded the biopharma startup

FDA In Brief: FDA expands work with Scholastic with launch of new youth e-cigarette prevention educational resources for middle and high schools

The U.S. Food and Drug Administration continues to work with Scholastic, the global children’s publishing, education and media company, to develop new youth e-cigarette prevention resources for schools. Today, the FDA and Scholastic are expanding their collaboration to launch their first middle school resources in addition to new resources for high schools. Last week, the FDA released the results of ...

Tuesday, November 12, 2019

DEA sues Colorado pharmacy board for prescription data THE ASSOCIATED PRESS NOVEMBER 12, 2019 04:37 PM, UPDATED 4 HOURS 50 MINUTES AG

https://www.thestate.com/news/article237295534.html

Fagron Holding To Pay $22M To Resolve Allegations Of False And Inflated AWPs For Ingredients Used in Compound Medicines Posted on November 12, 2019 by admin

http://morningsidemaryland.com/fagron-holding-to-pay-22m-to-resolve-allegations-of-false-and-inflated-awps-for-ingredients-used-in-compound-medicines/

Florida, San Antonio whistleblowers lead to $22.5 million settlement in pharmacy fraud case Photo of Guillermo Contreras Guillermo Contreras Nov. 11, 2019 Updated: Nov. 11, 2019 7:41 p.m.

https://www.expressnews.com/news/local/article/San-Antonio-and-Florida-whistleblowers-of-14826314.php
Mintz
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years
Reed Smith
On October 22, 2019, the U.S. Food and Drug Administration ("FDA") and the Federal Trade Commission ("FTC") issued a public statement regarding a joint warning letter sent to Rooted Apothecary, LL
Squire Patton Boggs LLP
On October 31, the US Department of Agriculture (USDA) published an interim final rule to establish the Domestic Hemp Production Program
Duane Morris LLP
Late last week, the FDA-in denying a citizen petition and issuing two Federal Register notices-modified published guidance on the manufacture and distribution of homeopathic drugs.
Seyfarth Shaw LLP
Seyfarth Synopsis: Through a reintroduced House bill, Congress is taking strides to push for cosmetic regulation reform and, separatel

CMS wants to crack down on supplemental Medicaid payments


As Medicaid supplemental state payments have become a larger proportion of total program payments, the CMS wants to increase transparency and oversight of the funding.
READ MORE >

Friday, November 8, 2019

Washington State Pharmacy Quality Assurance Commission November 2019 Newsletter

November

Virginia Board of Pharmacy November 2019 Newsletter

November

Utah Board of Pharmacy November 2019 Newsletter

November

Ohio Board of Pharmacy November 2019 Newsletter

November

Massachusetts Board of Pharmacy November 2019 Newsltter

November

Iowa Board of Pharmacy Enforcement of USP Chapters 795, 797, and 800

10/09/2019 – Iowa Board of Pharmacy Enforcement of USP Chapters 795, 797, and 800

Delaware State Board of Pharmacy November 2019 Newsletter

2019

California Board of Pharmacy Compounding Committee Meeting Materials 11/5/2019

November 5, 2019Department of Consumer Affairs
1625 N. Market Blvd.,1st Floor Hearing Room
Sacramento, CA 95834
11/5/19
Agenda
11/5/19
Meeting Materials

California Board of Pharmacy Board of Pharmacy Update November 2019

Board of Pharmacy Update - November (PDF)

California Board of Pharmacy Compounding Requirements Pending USP Appeals 11/7/2019

Compounding Requirements Pending USP Appeals – 11/7/19
Beginning January 1, 2020, a schedule II controlled substance that is an opioid may only be dispensed with an electronic prescription order as mandated by statute. Visit our FAQs page or H.B. 2075 for more information

Alaska Board of Pharmacy Meeting Scheduled November 14-15, 2019 (Agenda attached)

November 14 – 15

Juneau – Conference Room A
Anchorage – Suite 1550
November 14 (Day 1)
Agenda
November 15 (Day 2)
Agenda

Alaska Board of Pharmacy Notice of Adopted Changes to Regulations

Public Notice:

Notice of Adopted Changes to the Regulations of the Board of Pharmacy

On June 27, 2019, the Board of Pharmacy adopted regulation changes in Title 12, Chapter 52 of the Alaska Administrative Code. The regulations concern adding new licensing categories (non-resident wholesale drug distributor license, outsourcing facilities, and third-party logistics providers), licensure and registration requirements, etc.
The regulation changes were reviewed and approved by the Department of Law, signed and filed by the Lieutenant Governor on October 1, 2019, and will go into effect on October 31, 2019. Please click HERE to see the filed version of the regulations.
On June 3, 2019, the Department of Commerce, Community, and Economic Development adopted regulation changes in Title 12, Chapter 02 of the Alaska Administrative Code. The regulations concern occupational licensing fees for professions regulated by the Board of Pharmacy.
The regulation changes were reviewed and approved by the Department of Law, signed and filed by the Lieutenant Governor on October 1, 2019, and will go into effect on October 31, 2019. Please click HERE to see the filed version of the regulations.
The new regulation changes will be printed in Register 232, January 2020 of the Alaska Administrative Code.

Alabama Board of Pharmacy November 2019 Newsletter

November

Alabama Board of Pharmacy Statement on USP

USP Statement:
Until there is definite finality regarding the proposed changes to USP in connection with compounding and hazardous drugs, the Board presently will require compliance with USP 795 (v. 2014) and USP 797 (v. 2008).

White House says Pelosi plan to lower drug prices 'unworkable' BY JESSIE HELLMANN - 11/08/19 12:10 PM EST

https://thehill.com/policy/healthcare/469608-white-house-calls-pelosis-plan-to-lower-drug-prices-unworkable-and-hyper

Senate fight derails bipartisan drug pricing bills BY PETER SULLIVAN - 11/07/19 06:09 PM EST

https://thehill.com/policy/healthcare/469523-senate-fight-derails-bipartisan-drug-pricing-bills

Senate Rolling Out Plan To Tame Drug Prices November 07, 2019 Matt Murphy, State House News Service

https://www.wbur.org/commonhealth/2019/11/07/medication-pricing-bill-legislature-health-care

Another Voice: Pharmacy benefit manager legislation needs retooling

https://buffalonews.com/2019/11/07/another-voice-pharmacy-benefit-manager-legislation-needs-retooling/

Judge Goodwin: DEA had no evidence to support Oak Hill pharmacy suspension By Erin Beck The Register-Herald Nov 7, 2019

https://www.fayettetribune.com/news/judge-goodwin-dea-had-no-evidence-to-support-oak-hill/article_065d18f2-0177-11ea-bbf2-7f5514bd8f62.html

'I don't think we realized': Pikeville pharmacy combats opioid use with CBD products

https://www.wymt.com/content/news/I-dont-think-we-realized-Pikeville-pharmacy-combats-opioid-use-with-CBD-products-564632301.html

Statements from the five pharmacy chains that ordered the most opioids

https://www.washingtonpost.com/investigations/2019/11/07/statements-five-pharmacy-chains-that-ordered-most-opioids/

Walgreens acted as its own distributor and, according to a lawsuit, failed to report suspicious orders of pain pills and prevent diversion to the black market. By Jenn Abelson, Aaron Williams, Andrew Ba Tran, Meryl Kornfield

https://investigativereportingworkshop.org/investigation/the-pharmacy-the-pills-and-the-crisis/

USP 800: What healthcare organizations should know Alia Paavola - Tuesday, November 5th, 2019

https://www.beckershospitalreview.com/pharmacy/usp-what-healthcare-organizations-should-know.html

United States: Wrap-Up Of October Congressional Health Policy Hearings Last Updated: November 8 2019 Article by Debra A. McCurdy

http://www.mondaq.com/unitedstates/x/861832/Healthcare/WrapUp+Of+October+Congressional+Health+Policy+Hearings

'Gruesome' evidence tainted meningitis outbreak trial, exec's lawyer says Nate Raymond 1 MIN READ

https://www.reuters.com/article/health-meningitis/gruesome-evidence-tainted-meningitis-outbreak-trial-execs-lawyer-says-idUSL2N27L225

Mississippi pharmacy owner gets 10 years for $243M Tricare fraud scheme Maia Anderson - Monday, November 4th, 2019

https://www.beckershospitalreview.com/pharmacy/mississippi-pharmacy-owner-gets-10-years-for-243m-tricare-fraud-scheme.html

Answers to Questions About USP’s Notice of Intent to Revise New Compounding Standards Quarles & Brady LLP

https://www.lexology.com/library/detail.aspx?g=4962ec6d-58cc-4dc0-a14c-d313b7c0c4ed

Drug strengths, stability of compounded levothyroxine suspensions vary widely

https://www.healio.com/endocrinology/thyroid/news/online/%7Bab7c3eb4-9c1c-4bb6-a545-1fb9b3a45f88%7D/drug-strengths-stability-of-compounded-levothyroxine-suspensions-vary-widely

Barry J. Cadden and Glenn Chin were transported from federal prisons in Pennsylvania and arrived in Livingston County Wednesday night: Hearings Set Next Week In Tainted Steroid Deaths November 8, 2019

https://www.whmi.com/news/article/hearings-set-next-week-tainted-steroid-deaths

White House and Pelosi part ways on relief for drug prices by RICARDO ALONSO-ZALDIVAR Associated Press

https://abcnews4.com/news/nation-world/white-house-and-pelosi-part-ways-on-relief-for-drug-prices

Wilkerson Partner In "Cream Scheme" Case Says He Got Involved After Cream Cured His Mama; Exasperated Judge Threatens To Hold Entire Courtroom In Contempt Friday, November 8, 2019

Wilkerson Partner In "Cream Scheme" Case Says He Got Involved After Cream Cured His Mama; Exasperated Judge Threatens To Hold Entire Courtroom In Contempt Friday, November 8, 2019
17 hours ago - According to Thursday's statement, suppliers like Freedom sell ingredients or chemicals to compounding pharmacies, which then prepare and fill compound 

he Texas State Board of Pharmacy hears testimony from TPA CEO Debbie Garza and Speaker-Elect Rannon Ching about expanding technician supervision ...

8 hours ago - The Texas State Board of Pharmacy hears testimony from TPA CEO Debbie Garza and Speaker-Elect Rannon Ching about expanding technician supervision ...


Compound Ingredient Supplier Fagron Holding USA LLC to Pay $22.05 Million to Resolve Allegations of False and Inflated Average Wholesale Prices for Ingredients Used in Compounded Prescriptions

Department of Justice
U.S. Attorney’s Office
Western District of Texas

FOR IMMEDIATE RELEASE
Thursday, November 7, 2019

Compound Ingredient Supplier Fagron Holding USA LLC to Pay $22.05 Million to Resolve Allegations of False and Inflated Average Wholesale Prices for Ingredients Used in Compounded Prescriptions

WASHINGTON – The Department of Justice announced today that Fagron Holding USA LLC (Fagron) has agreed to pay $22.05 million to resolve allegations concerning the establishment of false and inflated Average Wholesale Prices (AWPs) by its wholly owned subsidiary Freedom Pharmaceuticals Inc. (Freedom) for active pharmaceutical ingredients used in compound prescriptions.  Freedom’s pricing scheme caused pharmacies that purchased Freedom’s compound ingredients to submit false prescription claims to the Defense Health Agency, which administers the TRICARE Program for the Department of Defense and the Department of Labor’s Office of Workers Compensation Programs (federal healthcare programs).
“We will not allow the systematic abuse of federal healthcare programs through pricing schemes designed to enrich a few at the expense of federal taxpayers,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division.  “Our commitment to protect these programs extends not only to the pursuit of those that submit fraudulent claims but also those who cause others to submit such claims.”
Compounding pharmacies purchase ingredients or chemicals from ingredient suppliers such as Freedom to prepare and fill compound prescriptions for patients who require a specially made prescription that is not generally available in the marketplace.  Freedom knew that compound prescription reimbursement under these federal programs was based in part on the AWPs it reported to various price listing agencies for its ingredients.  Freedom knowingly inflated the AWPs for its ingredients in order to increase the reimbursement that its pharmacy customers received from federal healthcare programs for using Freedom’s ingredients.  For example, Freedom established an AWP for the ingredient Fluticasone Propionate at $3,500 per gram even though it typically sold the Fluticasone Propionate for approximately $160 per gram.    
Freedom promoted its high AWPs and the resulting profit potential from the reimbursement of compound prescriptions as an inducement to pharmacies to purchase its ingredients.  Freedom’s fraudulent pricing scheme for its ingredients enabled its pharmacy customers to bill federal healthcare programs thousands of dollars per prescription for some compound formulations. 
“We have no tolerance for the abuse of federal healthcare programs, especially where it impacts the healthcare program for our veterans and their families,” said U.S. Attorney John Bash of the Western District of Texas.
“Deception and avarice have no place in our healthcare system,” said U.S. Attorney Maria Chapa Lopez of the Middle District of Florida. “Taxpayers expect that the programs they fund be administered according to the law and utilized for the purposes that they were intended. We will continue to guard against abuse of healthcare programs to ensure that patients receive the care they deserve.”
The settlement also resolves allegations that Fagron’s wholly owned pharmacy subsidiary, Pharmacy Services Inc. (PSI) and its pharmacy affiliates, submitted fraudulent compound prescription claims to federal healthcare programs, used sham insurance programs to manipulate pricing, paid kickbacks to physicians for bogus consulting agreements, and illegally waived copays.  It also addresses allegations against another Fagron subsidiary, B&B Pharmaceuticals Inc. (B&B), for setting an inflated AWP for Gabapentin. 
The settlement resolves allegations contained in two separate actions filed against Freedom, PSI, and B&B under the whistleblower or qui tam provisions of the False Claims Act.  Under the False Claims Act, private parties may sue on behalf of the government for false claims for government funds and to receive a share of any recovery.   The whistleblowers will receive a combined total of $3,749,000 plus accrued interest from the proceeds of the settlement.  The two lawsuits are captioned United States ex rel. Hueseman v. PSI et al., (WDTX) and United States ex rel. Sten v. Midwest Compounders, et al., (NDIA). 
The case was handled by the Civil Division, Commercial Litigation Branch, the U.S. Attorney’s Offices for the Western District of Texas and the Middle District of Florida, with investigative support from the Defense Criminal Investigative Service, U.S. Postal Service, Department of Labor, and the U.S. Drug Enforcement Agency. 
Topic(s): 
False Claims Act
Component(s): 

Thursday, November 7, 2019

Tenet proposes $66 million settlement in false claims case

The whistleblower lawsuit alleged Tenet Healthcare Corp. billed public programs for services provided by physicians who had improper financial relationships with one of its hospitals in Oklahoma

Tuesday, November 5, 2019

California Board of Pharmacy Board of Pharmacy (Part 2) - Enforcement & Compounding Comm. Meeting - June 7, 2018

https://www.youtube.com/watch?v=kaDIxpFwSiM

Drug Compounding Christopher M. Day column: From good to bad if left uncontrolled By Christopher M. Day 16 hrs ago


https://www.richmond.com/opinion/columnists/christopher-m-day-column-from-good-to-bad-if-left/article_069f27d5-d1ec-5782-b9bb-4a48b2111ba7.html

FDA Warning Letters to Companies Illegally Marketing animal drugs without FDA approval in 2019

FDA issued the following Warning Letters to companies that were illegally marketing animal drugs without FDA approval:

Zydus Cadila injectables plant slapped with FDA warning letter over contamination risks

Monday, November 4, 2019
India’s Zydus group began steps to fix its perpetually troubled sterile manufacturing plant in Moraiya as soon as an FDA inspector uncovered manufacturing issues this spring. Its efforts failed to do the job. 

Friday, November 1, 2019

meningitis-etc: Deal on Cadden House

meningitis-etc: Deal on Cadden House: By Walter F. Roche Jr. A buyer has apparently been found for the 9,000 square foot home of a jailed former drug company executive and the ...
4 days ago - Documentation of pharmacies' Prescription Drug Event data. ▫ Are claims .... pharmacies for expensive compound drugs resulting in approximately. $92 million .