Pages

Thursday, June 22, 2017

Four GOP senators oppose Senate health-care measure in its current form

GOP fights with itself over new health care plan

Trump says he is 'very supportive' of Senate healthcare bill

Senate health care bill: How it would affect you

President Obama just blasted the Senate health bill as a “massive transfer of wealth” to the rich

Wickliffe Pharmaceuticals Inc., NRP 1145, Administrative Case 5856
Lexington, KY
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for three years and is subject to the terms and conditions in the decision.
Decision effective 4/20/2017.
View the decision
Wickliffe Pharmaceuticals Inc., NSC 99710, Administrative Case 5856
Lexington, KY
Through a disciplinary action of the Board, the license is revoked, the revocation is stayed, and the licensee is placed on probation for three years and is subject to the terms and conditions in the decision.
Decision effective 4/20/2017.
View the decision

Owner, director of compliance at Noblesville compounding ...

Fox 59-10 hours ago
INDIANAPOLIS, Ind. — The owner and director of an Indiana compounding pharmacy face multiple charges according to a federal indictment. They're accused ...
Compounding Pharmacy Officials Facing Federal Charges
Inside INdiana Business-8 hours ago
Former Pharmakon owner arrested for distribution of over- and ...
Local Source-Current in Noblesville-1 hour ago
06/22/2017 04:24 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Triple Miracle Zen Plus 1200mg, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.
.
06/22/2017 03:54 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Xzone Gold, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites, and possibly sold in some retail stores.
06/22/2017 03:54 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Own the Knight 1750, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.
06/22/2017 03:54 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Royal Master 1500, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.
06/22/2017 03:54 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Macho Man 3000, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.
06/22/2017 03:20 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Love Zen 3000, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.
06/22/2017 03:54 PM EDT

The Food and Drug Administration is advising consumers not to purchase or use Monster X 1350, a product manufactured by SHH Trading and promoted for sexual enhancement on various websites and possibly sold in some retail stores.
06/22/2017 02:06 PM EDT

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Man of Steel 2, a product promoted and sold for sexual enhancement on various Web sites, including www.manofsteelpills.com, and possibly in some retail stores.
06/22/2017 02:33 PM EDT

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Super Panther 7K, a product promoted and sold for sexual enhancement on various Web sites, including www.ultraxshop.com, and possibly in some retail stores.
06/22/2017 02:33 PM EDT

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Super Panther 7K, a product promoted and sold for sexual enhancement on various Web sites, including www.ultraxshop.com, and possibly in some retail stores.
.

Trump says Senate health bill will be 'negotiated'

Senate GOP leaders unveil health-care bill

4 very real scenarios that could doom the Senate’s health-care bill

At Heart of Health Bill Is $800 Billion Medicaid Rollback

Senate GOP health bill seeks to hobble Obama law

BREAKING: Senate Republicans release discussion draft of ACA repeal bill
Senate Republicans have released a "discussion draft" of their bill to repeal and replace the Affordable Care Act that would sharply curtail the law's financial assistance to lower- and middle-income people to obtain affordable healthcare coverage.  READ MORE

Doctors 'gun shy' to prescribe opioids hurting those in pain, say ... CBC.ca-6 hours ago

Pricing overhaul

Australian Journal of Pharmacy (registration) (blog)-9 hours ago
The interim report of the Review of Pharmacy Remuneration and Regulation (also known ... A standard fee for the remuneration for compounding chemotherapy 

Shreveport whistleblower reacts to latest VA report

KTBS-18 hours ago
... at Overton Brooks -- revelations that pharmacy managers failed to tell hospital or VA officials about unsanitary conditions in the compounding pharmacy -- that ...

Barry Cadden: What to know about the ex-pharmacy exec tied to ...

Fox News-19 hours ago
Barry Cadden, co-founder of the New England Compounding Center (NECC), the now-defunct pharmaceutical company linked to a 2012 deadly meningitis .

High Importance! Pharmakon Compounding Pharmacy-Pharmacy Owner and Director of Compliance Charged with Defrauding United States and Distributing Adulterated Drugs Indictment Attached

Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Thursday, June 22, 2017

Pharmacy Owner and Director of Compliance Charged with Defrauding United States and Distributing Adulterated Drugs

The owner and director of compliance of an Indiana compounding pharmacy were charged criminally in connection with their distribution of over- and under-potent drugs, and defrauding the United States by interfering with and obstructing the lawful functions of the Food and Drug Administration (FDA), the Department of Justice announced today.
J. Elmer, 64, of Fishers, Indiana, and Caprice R. Bearden, 62, of Carmel, Indiana, were charged in a 10-count indictment with one count of conspiracy to defraud the United States, three counts of distributing an adulterated drug in interstate commerce and six counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce. Elmer was arrested yesterday and had his initial court appearance in U.S. District Court in the Southern District of Indiana where he pleaded not guilty and was released under conditions imposed by the Court. Trial has been scheduled for Aug. 21 at 9 a.m.
“The distribution of over- and under-potent drug products poses a serious risk of harm to patients,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “FDA’s efforts to ensure the safety of compounded drugs is critically important. Impeding FDA’s ability to do its job and uncover these types of safety concerns will not be tolerated. The Justice Department is committed to working with FDA to protect patients and ensure compounded drugs are safe.”
“These defendants put greed and the reputation of their company ahead of the health and safety of our most innocent victims,” said U.S. Attorney Josh Minkler for the Southern District of Indiana. “Their actions put lives in danger and they will be held accountable.”
Elmer owned and was the President of Pharmakon Pharmaceuticals Inc. (Pharmakon), and Bearden was the company’s Director of Compliance. Pharmakon compounded drugs at a facility in Noblesville, Indiana for customers in Indiana and many other states.
The indictment alleges that from July 2013 through mid-February 2016, Bearden received approximately 70 potency test failure notices from companies used by Pharmakon to test for potency, indicating that drugs such as morphine sulfate and fentanyl were either under- or over-potent. According to the indictment, Bearden discussed the out-of-specification test results with Elmer, a licensed pharmacist, and until Pharmakon compounded over potent morphine sulfate in February 2016, Elmer determined that Pharmakon should not contact any individuals or entities – including hospitals – who received the drugs, nor conduct any product recalls before FDA intervention.
On several occasions, according to the indictment, infants were injected with drugs compounded by Pharmakon - that were significantly over-potent. For example, the indictment alleges that in early February 2016, Pharmakon distributed over potent morphine sulfate, an opioid typically used for relief of moderate to severe acute and chronic pain, to a hospital in Indiana and a hospital in Illinois. As alleged in the indictment, three infants at the hospital in Indiana received the morphine sulfate which was nearly 25 times the strength indicated on its label, and one infant was taken by emergency helicopter to a nearby children’s hospital.
Further, as alleged in the indictment, during FDA inspections of Pharmakon in 2014 and 2016, Bearden lied about Pharmakon’s never having received any out-of-specification drug potency test results. According to the indictment, Elmer learned of Bearden’s lies during or shortly after the FDA’s inspections and took no action to correct her and to inform the FDA of the extent of Pharmakon’s drug potency failures. The indictment alleges that Elmer and Bearden conspired to defraud the United States by interfering with and obstructing the lawful functions of the FDA, and obstructing, influencing and impeding FDA inspections. In addition, as alleged, during the 2016 inspection, Elmer directed at least one Pharmakon employee to backdate batch records of compounded drugs.
“Companies that do not meet federal manufacturing standards, especially when dealing with highly potent drugs like fentanyl meant for vulnerable populations, put the health and safety of American consumers at great risk,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA and our Office of Criminal Investigations will continue to pursue and help bring to justice those companies who put the public health at risk.”
According to the indictment, during two inspections of Pharmakon in 2014, FDA observed conditions that did not comply with FDA regulations. The indictment alleges that Elmer and Bearden failed to investigate the root causes of the drug potency failures and otherwise failed to make changes in Pharmakon’s compounding operations to reduce the incidence of these failures. Instead, as alleged in the indictment, under the direction and supervision of Elmer and Bearden, Pharmakon continued to distribute under- and over-potent drugs, shipping these drugs before receiving the potency test results.
The conspiracy charge carries a statutory maximum sentence of five years in prison and a fine of $250,000 or twice the gross gain or gross loss from the offense. The charges of distributing an adulterated drug in interstate commerce and adulterating drugs while held for sale after shipment of a drug component in interstate commerce each carry a statutory maximum punishment of one year in prison and a fine of $100,000 or twice the gross gain or gross loss from the offense.
Acting Assistant Attorney General Readler and U.S. Attorney Minkler commended the FDA Office of Criminal Investigations, which conducted the investigation. The case is being prosecuted by Assistant U.S. Attorney Cindy J. Cho, of the U.S. Attorney’s Office for the Southern District of Indiana and Trial Attorney David A. Frank of the Civil Division’s Consumer Protection Branch.
For more information about the Consumer Protection Branch, visit its website at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Indiana visit its website at https://www.justice.gov/usao-sdin.

Two officials at Noblesville compounding pharmacy face federal drug ...

cbs4indy.com/.../department-of-justice-fda-announcing-charges-against-noblesville-c...
2 hours ago - INDIANAPOLIS, Ind. -- The owner and director of an Indiana compounding pharmacy face multiple charges according to a federal indictment. They're accused of ...

Breaking News! Owner, director of compliance at compounding pharmacy faces multiple charges in a federal indictment

Owner, director of compliance at Noblesville compounding pharmacy ...

fox59.com/.../u-s-attorney-fda-officials-announce-charges-against-noblesville-compo...

2 hours ago - BREAKINGINDIANAPOLIS, Ind. — The owner and director of an Indiana compoundingpharmacy face multiple charges according to a federal indictment.

FDA Law Blog--June 21, 2017 A Meeting to Discuss FDA’s Continuing Conundrum: Innovation vs. Access By Sara W. Koblitz –

Hospira recall of vials adds to woes of sodium bicarbonate shortage by Joseph Keenan | Jun 20, 2017 10:03am

Lucid issues recall of 69,000 bottles of antidepressant meds

FDA outlines data integrity problems with Chinese API maker under import ban

Wednesday, June 21, 2017

Compounded meds legislation introduced in House

Compounded meds legislation introduced in House: Compounded meds legislation introduced in House

GOP Might Buck Senate Rules to Pass Health Care Overhaul

Senator Susan Collins (R-ME) and FDA Administrator Scott ... - C-Span

https://www.c-span.org/video/?c4674247/senator-susan-collins-fda-administrator...
21 hours ago - June 20, 2017 Senator Susan Collins (R-ME) and FDA Administrator Scott Gottlieb Sen. Collins (R-ME) inquires of Administrator Gottlieb what is needed to end 

BRIEF-U.S. FDA says it is working to lift barriers to generic drug ...

www.reuters.com/article/brief-us-fda-says-it-is-working-to-lift-idUSFWN1JI0MI
55 mins ago - U.S. FDA's Scott Gottlieb says FDA working to lift barriers to generic drug competition. * U.S. FDA's Gottlieb says while FDA doesn't have a direct role in drug ...

Gottlieb: FDA Drafting Medical Innovation Plan To Help Lower Health ...

https://insidehealthpolicy.com/.../gottlieb-fda-drafting-medical-innovation-plan-help-l...
15 hours ago - FDA will create a “Medical Innovation Development Plan” aimed at lowering health care costs by facilitating development of drugs to treat costly rare diseases ...

FDA chief deflects questions on fighting opioid epidemic if ACA is ...

www.modernhealthcare.com/article/20170620/NEWS/170629987
18 hours ago - FDA Commissioner Dr. Scott Gottlieb said on Tuesday he has not discussed with the group of GOP senators currently working on a version of a replacement bill ...

Will Trump's FDA bend the rules? Coming Portola decision could be a

Will Trump's FDA bend the rules? Coming Portola decision could be a ...

https://www.statnews.com/2017/06/21/portola-drug-fda-decision/
6 hours ago - A coming FDA decision on Portola's anticoagulant, which failed a clinical trial, will be a clue about the agency's drug approval standards in the Trump era.

DEA: China to Schedule Controls of New Fentanyl-Class Substances ...

https://americansecuritytoday.com › Crisis Responders › Disaster Prevention
14 hours ago - Representatives from the China National Narcotics Laboratory, the Narcotics Control Bureau, and the Ministry of Public Security met with DEA officials to .

DEA bust recovers enough opioid drugs to kill 1.4 million people

https://www.consumeraffairs.com/.../dea-bust-recovers-enough-opioid-drugs-to-kill-1...
21 hours ago - Drug Enforcement Agency officials busted three California residents with enough fentanyl to kill every person in the state of Illinois.

3 indicted after DEA agents seize record 100 lbs of fentanyl - RT.com

https://www.rt.com/usa/393277-3-indicted-dea-fentanyl-seizure/
18 hours ago - A long-term investigation led to one of the nation’s largest seizures of the synthetic opiate fentanyl and a federal indictment against three accused drug traffickers, the US Drug Enforcement Administration (DEA) has said. ... “44.14 kilograms (100 pounds) of fentanyl represents ...

In Huge Drug Bust, DEA Seizes Nearly 100 lbs. of Fentanyl, Arrests ...

freebeacon.com/.../in-huge-bust-dea-seizes-nearly-100-lbs-of-fentanyl-arrests-three/
19 hours ago - A federal investigation has led to a massive drug bust in San Diego, Calif., with three people charged and nearly 100 pounds of fentanyl seized by Drug Enforcement Administration agents.... A lethal dose of fentanyl is just three milligrams, and the DEA's seizure represents over 14 ...