Thursday, February 26, 2015
Second Question of the Day February 26, 2015 Did the Alliance for Natural Health just make the argument that Congress should give the FDA full authority over compounding pharmacies by acknowledging that compounding has an impact on interstate commerce and asking that it be "protected?" For a federal bill to pass constitutional muster, there is no requirement that 30% or even 5% be allowed to go unregulated, is there?
Alliance of Natural Health Complaining because the FDA increased the 5% to 30% in the recent draft guidance and asking for its supporters to reach out to Congress to now protect compounders' interstate shipment
FDA Pretends to Lighten Burden on Compounding ...
www.anh-usa.org/fda-pretends-to-lighten-burden-on-compounding-phar...2 days ago - Action Alert! Tell the FDA and Congress that any limit on interstate sales of vital compounded drugs such as estriol or extended release thyroid ...You visited this page on 2/24/15.
FDA Press Release: February 24, 2015: Additional Charges Filed Against Doctor in Pill Mill Case
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U.S. Department of Justice Press Release
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For Immediate Release
February 24, 2015 |
United States Department of Justice
Eastern District of Pennsylvania
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William J. O’Brien III, 49 of Philadelphia was charged today by Superseding Indictment with 23 additional counts of illegally distributing oxycodone, methadone, and amphetamines, all Schedule II controlled substances, outside the usual course of professional practice and for no legitimate medical purpose, announced United States Attorney Zane David Memeger. According to the superseding indictment, O’Brien’s so-called Apatients@ could for a fee obtain prescriptions for these addictive and dangerous controlled substances without a physical examination or any other medical care or treatment. O’Brien typically charged customers $250 cash for the first appointment to buy prescriptions and $200 for each appointment to obtain refills.
On January 29, 2015, an indictment was unsealed charging O’Brien, a doctor of osteopathic medicine, and Angela Rongione, with one count of conspiracy to distribute controlled substances. In the same indictment, O’Brien was charged separately with 26 counts of illegally distributing Oxycodone and Xanax, a Schedule IV controlled substance, for selling prescriptions for these narcotics to a government cooperator and an undercover FBI agent. The counts charged in the superseding indictment are for additional “patients” to whom O’Brien allegedly sold prescriptions.
If convicted, the defendants face substantial prison terms and fines, and are subject to criminal forfeiture proceedings.
The case was investigated by the Federal Bureau of Investigation, FDA Office of Criminal Investigations, and teh Department of Health and Human Services - Office of the Inspector General, and is being prosecuted by Assistant United States Attorney M. Beth Leahy.
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FDA Press Release: February 20, 2015: CEO of Kentwood Pharmacy Pleads Guilty
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U.S. Department of Justice Press Release
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For Immediate Release
February 20, 2015 |
United States Department of Justice
Western District of Michigan
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GRAND RAPIDS, MICHIGAN — Kim Duron Mulder, 55, formerly of Grand Rapids, and Charles Wayne Brooks, 63, of Alma, entered guilty pleas today before United States District Judge Robert J. Jonker on charges related to the illegal restocking and re-dispensing of recycled drugs at Kentwood Pharmacy. Mr. Mulder, formerly the CEO of Kentwood Pharmacy, pled guilty to a conspiracy to commit health care fraud based on billing Medicare, Medicaid, and private insurance plans for misbranded and adulterated drugs. Mr. Brooks, a pharmacist at Kentwood Pharmacy’s facility in Alma, pled guilty to misbranding prescription drugs that had been previously dispensed and returned to pharmacy stock. Mr. Mulder faces up to ten years’ imprisonment; Mr. Brooks faces up to three years’ imprisonment.
The convictions of Messrs. Mulder and Brooks conclude the federal prosecution of individuals involved with Kentwood Pharmacy. A total of 18 people were convicted of criminal offenses stemming from the practices at Kentwood Pharmacy, including the felony convictions of six licensed pharmacists. Most recently, in December 2014, Judge Jonker sentenced Richard Clarke, formerly Kentwood Pharmacy’s Vice President of Sales, to 14 years in prison for his involvement in a conspiracy to commit health care fraud and a separate charge of possession of child pornography. In December 2014, Judge Jonker also sentenced pharmacist Lawrence Harden to six years’ imprisonment for his involvement in the conspiracy to commit health care fraud. As part of the sentencing hearings, Judge Jonker found that public and private insurers paid more $80,000,000.00 for adulterated and misbranded drugs. Judge Jonker found that Messrs. Clarke and Harden were responsible for restitution amounts of over $8,000,000.00 and $6,000,000.00, respectively.
The federal investigation revealed that Kentwood Pharmacy violated state pharmacy rules and federal law by recycling drugs that were returned from nursing homes and adult foster care homes. These included cross-contaminated drugs that were previously mixed together, drugs bearing foreign substances and residues, and discolored and expired medications. The process by which Kentwood Pharmacy returned drugs to pharmacy stock resulted in the improper labeling of drugs, the placement of different drug dosages into stock bottles, and the placement of the altogether wrong drugs into stock bottles. Because Kentwood Pharmacy did not trace the returned drugs, at least one defendant was able to take and sell controlled prescriptions on the street in northern Michigan.
U.S. Attorney Patrick Miles said, “The Federal Food Drug and Cosmetic Act provides an essential regulatory framework to safeguard the public’s use of prescription drugs. These federal regulations are buttressed by explicit state laws which strictly limit the reuse of drugs which have left the control of pharmacies. The public must be able rely on pharmacists who have both professional and statutory duties to ensure that pharmacies operate in compliance with these federal and state laws regulating the handling, packaging, and distribution of drugs.”
This case was investigated by the U.S. Food and Drug Administration, the Federal Bureau of Investigation, the U.S. Drug Enforcement Administration, the U.S. Department of Health and Human Services, and the Internal Revenue Service. Assistant U.S. Attorneys Raymond E. Beckering III and Adam B. Townshend prosecuted the cases on behalf of the United States.
The investigation of this case was initiated by confidential tips. If Michigan residents or medical professionals suspect possible violations of law or other dangerous practices involving pharmacies or prescription drugs, they can contact the FDA at http://www.fda.gov/ICECI/ criminalInvestigations/default.htm or the DEA athttp://www.justice.gov/dea/ops/submit.shtml.
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Press Release: 37-count indictment was unsealed in Brooklyn federal court charging Med Prep Consulting,Inc. (“Med Prep”), a Tinton Falls, New Jersey, medical drug re-packager and processer, together with its president and owner Gerald Tighe and pharmacist-in- charge Stephen Kalinoski, with wire fraud and violations of the Federal Food, Drug and Cosmetic Act (“FDCA”) for introducing adulterated and misbranded drugs into interstate commerce with the intent to defraud and mislead the U.S. Food and Drug Administration (“FDA”) and Med Prep’s customers
February 19, 2015: Medical Drug Re-Packager and Company's Senior Executives Indicted on Fraud Charges and Criminal Violations of the Food, Drug and Cosmetic Act
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U.S. Department of Justice Press Release
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For Immediate Release
February 19, 2015 |
United States Department of Justice
Eastern District of New York
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Earlier today, a 37-count indictment was unsealed in Brooklyn federal court charging Med Prep Consulting,Inc. (“Med Prep”), a Tinton Falls, New Jersey, medical drug re-packager and processer, together with its president and owner Gerald Tighe and pharmacist-in- charge Stephen Kalinoski, with wire fraud and violations of the Federal Food, Drug and Cosmetic Act (“FDCA”) for introducing adulterated and misbranded drugs into interstate commerce with the intent to defraud and mislead the U.S. Food and Drug Administration (“FDA”) and Med Prep’s customers, who consisted of hospitals and other healthcare providers. The charges in the indictment are merely allegations, and the defendants are presumed innocent unless and until proven guilty.
The charges were announced by Loretta E. Lynch, United States Attorney for the Eastern District of NewYork, and Margaret A. Hamburg, M.D., Commissioner of the FDA.
According to the indictment, Med Prep processed numerous drugs, including oncology and dialysis drugs, pain medications, anesthesia drugs, and operating room drugs, in purportedly sterile conditions. In an effort to gain market share, Med Prep repeatedly misrepresented to its healthcare provider customers that itadhered to, and in some areas exceeded, industry standards and laws applicable to sterile drug preparation.In fact, the defendants produced drugs in a facility that fell far short of basic industry standards ofcleanliness, creating a risk to the health of already ill patients, and lied to healthcare providers about theirfailures to comply with basic sterility practices.
“As detailed in the indictment, Med Prep and its two most senior executives engaged in a disturbingpattern of dangerous practices in order to save money and line their pockets,” said U.S. Attorney Lynch.“Instead of working to extend and enhance human lives, the defendants illegally pursued corporate profits while putting at risk the health and safety of vulnerable patients suffering from disease. Thisindictment should send a strong message to those who would seek to put their bottom line before the health and safety of the public – those we entrust with preparing the medications that save lives must clean up their acts or face prosecution.” In announcing the indictment today, Ms. Lynch gratefullyacknowledged the assistance and cooperation of the FDA’s Office of Criminal Investigations; the United States Department of Health and Human Services, Office of the Inspector General, Office ofInvestigations; the United States Office of Personnel Management, Office of the Inspector General; theDepartment of Justice, Civil Division, Consumer Protection Branch and Commercial Litigation Branch;the FDA’s Office of the Chief Counsel; the Office of the Attorney General of New Jersey; and the NewJersey Board of Pharmacy.
“The production of unsafe and contaminated drug products poses a serious threat to the health of theAmerican public and cannot be tolerated,” said FDA Commissioner Hamburg. “We continue to use all ourauthorities and to work with the Department of Justice and the states to ensure such practices are quicklyidentified and stopped. Americans deserve nothing less.”
According to the indictment, Med Prep halted its production of drug products in the summer of 2013following an incident in which it had distributed intravenous drugs containing visible mold to a Connecticut hospital. Soon after mold was discovered, the FDA inspected Med Prep’s facility and documented numerous incidents of microbiological contamination in the company’s finished drug products. Notably, the investigators found that the same species of mold present in drugs sent to the Connecticut hospital was also present in Med Prep’s warehouse, where an unsterilized cart was regularly wheeled into a purportedly sterile“cleanroom” in which drugs were prepared by Med Prep employees. FDA investigators also found that MedPrep shipped drug products to healthcare providers in some instances that were mislabeled with incorrect drug strengths and in other instances were labeled as the wrong drugs altogether.
Prior to 2013, the FDA had conducted several inspections of Med Prep’s facilities and repeatedly warned thedefendants that their practices and the conditions in their facility were unacceptable. Tighe and Kalinoskiboth allegedly misrepresented to FDA investigators that Med Prep complied with industry standards designed to prevent harm to patients that could result from non-sterility, yet they continued to handle steriledrugs in conditions far below any acceptable industry standards. As early as May 2007, Kalinoski learned that a Med Prep employee responsible for repacking and processing drugs in Med Prep’s “cleanroom” failed to treat an eczema skin condition for approximately five to six months while working in that room. Thedefendants never disclosed the employee’s skin condition to the FDA, nor did they take steps to prevent thedelivery to, or issue a recall from, healthcare providers of any of the drug products with which the employeehad come into contact.
If convicted, the individual defendants face maximum prison sentences of 20 years on each wire fraudcharge, five years on the charge of conspiracy to violate the FDCA, and three years on each charge of violations of the FDCA.
The government’s case is being prosecuted by Assistant U.S. Attorneys Justin D. Lerer, Ameet B. Kabrawala, and Erin E. Argo.
quoted from here
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