Wednesday, January 31, 2018

Trump Targets Drug Prices, Right-to-Try in State of the Union Managed Markets Network-11 hours ago
A poll taken last fall by the Harvard School of Public Health found that 40% of Americans want Congress to bring down prescription drug prices—a higher score than any other issue surveyed, according to ... “Pfizer raised the price of its entire product line twice last year, and compounded effect is quite dramatic” Rother said.

FDA Press Release: January 31, 2018: New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak

             U.S. Department of Justice Press Release

For Immediate Release
January 31, 2019
United States Department of Justice
District of Massachusetts 
Boston -- The former supervisory pharmacist of New England Compounding Center (NECC) was sentenced today in connection with the 2012 nationwide fungal meningitis outbreak that killed 64 and caused infections in 793 patients.
Glenn Chin, 49, of Canton, Mass., was sentenced by U.S. District Court Judge Richard G. Stearns to eight years in prison, two years of supervised release, and forfeiture and restitution in an amount to be determined later. In October 2017, Chin was convicted by a federal jury in Boston of 77 counts, including racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead.

“Mr. Chin was a pharmacist, but again and again he acted with complete disregard for the health and safety of patients,” said United States Attorney Andrew E. Lelling. “Mr. Chin will now be held responsible for producing contaminated drugs that killed dozens and grievously harmed over 750 people across the country. No patient should suffer harm at the hands of a medical professional, and we will continue to work with our law enforcement partners to combat fraud and abuse in the health care system.”

“A key aspect of the FDA’s mission is to ensure that drugs are made under high quality conditions so that no patient is at risk of harm due to poorly compounded products,” said FDA Commissioner Scott Gottlieb, M.D. “In response to episodes where patients were harmed by poorly compounded drugs, Congress passed a new set of laws to improve the FDA’s oversight of these products. We’re committed to the efficient, timely and robust implementation of that framework to help make sure patients can trust the reliability and safety of compounded drugs, recognize the benefits of pharmacy compounding, and that we protect consumers from harm.”

“As a licensed pharmacist, Glenn Chin took an oath to protect his patients,” said Harold H. Shaw, Special Agent in Charge, FBI Boston Division. “In contrast, he failed miserably by cutting corners, ignoring warning signs, and harming hundreds of people with his reckless disregard for their safety.  Dozens of unsuspecting patients died because of the tainted drugs that were distributed on his watch.  Now, Mr. Chin is finally being held accountable for his role in one of the worst pharmaceutical disasters in this country. The FBI hopes today’s sentence will bring some comfort to the hundreds of victims and their families who have suffered so much.”

In 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of preservative-free methylprednisolone acetate (MPA) manufactured by NECC.  Of those 753 patients, the U.S. Centers for Disease Control and Prevention (CDC) reported that 64 patients in nine states died.  The government has since identified a total of 793 patients throughout the country harmed by NECC’s contaminated steroids.

Chin manufactured three lots of contaminated MPA, which comprised more than 17,000 vials of medication. In doing so, Chin ignored NECC’s own drug formulation worksheets and standard operating procedures. Specifically, he improperly sterilized the MPA, failed to verify the sterilization process, and improperly tested it to ensure sterility. Despite knowing these deficiencies, Chin directed the MPA to be filled into thousands of vials and shipped to NECC customers nationwide.  During the fungal meningitis outbreak, the CDC identified 18 different types of fungi from MPA vials and patient samples.  In the words of one public health official, NECC was a “fungal zoo.”

Chin directed the shipping of drugs prior to receiving test results confirming their sterility, and he directed NECC staff to mislabel drugs to conceal this practice. He also directed the compounding of drugs with expired ingredients, including chemotherapy drugs that had expired several years prior. Chin prioritized drug production over cleaning, directed the forging of cleaning logs, and routinely ignored mold and bacteria found inside the clean rooms. Lastly, for more than three years, Chin, along with co-conspirators, utilized a pharmacy technician whose license had been revoked by the Massachusetts Board of Pharmacy to compound highly sensitive cardiac drug solutions, and took steps to conceal the technician’s presence inside the clean room from state regulators. 

“One of the Defense Criminal Investigative Service’s (DCIS) priorities is to protect the integrity of TRICARE, the U.S. Defense Department's health care program,” stated Special Agent in Charge Leigh-Alistair Barzey, DCIS Northeast Field Office. “Today’s sentencing demonstrates DCIS’ commitment to work with the USAO-MA, the FBI, the FDA-OCI and its other law enforcement partners, to identify, investigate and prosecute individuals who disregard pharmaceutical regulations and endanger the health and safety of U.S. military members, retirees and their families.‎”

“The VA provides healthcare to those who have sacrificed so much for our country and fortunately no veterans receiving VA care were harmed by the fungal meningitis outbreak. However, it is appalling that NECC staff acted with such reckless disregard for patients by putting profits over safety,” said Special Agent in Charge Sean J. Smith for the Department of Veterans Affairs, Office of Inspector General.  “The VA Office of Inspector General is honored to work with our partners in law enforcement on such an important investigation and assist in bringing those individuals who were responsible to justice.”

“The sentence imposed today on Glenn Chin demonstrates the commitment of the U.S. Postal Inspection Service and our law enforcement partners, to the safety and health of the American public,” said Raymond Moss, Acting Inspector in Charge of the U.S. Postal Inspection Service, Boston Division.  “Chin’s actions as a supervising pharmacist jeopardized the health of many patients and we will continue to investigate and take action against those who take part in this type of egregious behavior.”

U.S. Attorney Lelling, FDA Commissioner Gottlieb, M.D., FBI SAC Shaw, DCIS SAC Barzey, VA OIG SAC Smith, and Acting Inspector in Charge of USPIS Moss made the announcement today.  Assistant U.S. Attorneys George P. Varghese and Amanda P.M. Strachan of Lelling’s Health Care Fraud Unit prosecuted the case.


FDA Law Blog: Guidance on Guidance: Enforcement to be Curtailed January 31, 2018 By Anne K. Walsh & Rachael E. Hunt —

“Brand Memo” Prohibits US DOJ From Converting Agency Guidance ...

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Former NECC pharmacist sentenced to 8 years in meningitis outbreak

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The former supervisory pharmacist at the New England Compounding Center in Framingham was sentenced to eight years in prison for his role in a fungal meningitis outbreak that killed 64 people and sickened hundreds. A U.S. District Court judge on Wednesday sentenced Glenn Chin, 49, of Canton, to eight years in ...
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Pharmacist to be sentenced for role in US meningitis outbreak
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Tuesday, January 30, 2018

DOJ to Appeals Court: Affirm DMAA Ruling

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Statement from FDA Commissioner Scott Gottlieb, MD, on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

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FDA, FTC Warn Companies Marketing Supplements as Opioid ...

CSPI Newsroom-Jan 24, 2018
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Misconceptions around horse supplements identified by researchers

Horsetalk-4 hours ago
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Here's How to Tell Whether Your Supplements Are Dangerous

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Vladimir Putin admits 'instances of doping' in Russian athletes

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Trump charges new HHS Sec. to combat opioid crisis, drug prices at ...

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Drugs kill more Americans than guns and cars. Kentucky was ...

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DEA To Target Opioid Over-Prescribers

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House panel to begin hearings on bills to fight opioid crisis

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The Opioid Epidemic: Costs, Causes, and Efforts to Fight It

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At least 14 NY counties and NYC suing opioid companies

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The practice, detailed in one part of a multi-part USA Today Network series, is spreading across New York and the country, with at least 14 states suing opioidmanufacturers, according to data from A large number of counties in Kentucky, Ohio and West Virginia are filing suits separate from their states.

Trump administration unclear on continuation of opioid 'emergency'

ABC News-Jan 29, 2018
President Donald Trump's order declaring the opioid crisis a public health emergency in October was set to expire last Tuesday — its 90-day mandate must be renewed upon expiration — leading to a lack of clarity in the commitment of the administration's response. In a statement released Jan. 22, acting Health and Human ...

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