MUST READ: High-Risk Compounding Pharmacies Targeted for FDA Review

About 30 “high risk” compounding pharmacies are being targeted by U.S. regulators for inspections over the next two months as part of intensified enforcement efforts after last year’s deadly meningitis outbreak.
The companies primarily make sterile drugs and distribute products to health-care providers nationwide, Erica Jefferson, a spokeswoman for the Food and Drug Administration, said today in a phone interview. The visits, which began Feb. 19 and will continue about two months, are the first proactive inspections the agency has conducted of compounding pharmacies, she said.
Facilities in Florida, Chicago, Arkansas and Mississippi were found with conditions that put their drugs at risk of microbiological contamination, the FDA said in four inspection reports today on its website. Drug compounders were thrust into the spotlight when New England Compounding Pharmacy Inc. shut down in October after its contaminated steroid shots were linked to a fungal meningitis outbreak that has killed 48 people.
“The recent tragic fungal meningitis outbreak has shed a harsh and important light on this area for us,” Jefferson said.
Compounding pharmacies traditionally prepare personalized prescriptions and are regulated by state health authorities. The meningitis outbreak revealed some companies go beyond that task by producing larger amounts of medicines, acting more like a drug manufacturer overseen by the FDA.
Typically the FDA waits for complaints against these pharmacies before doing inspections. Jefferson wouldn’t say how many of the businesses targeted have been inspected as of today.

Pharmacy Selection

The agency chose the pharmacies to inspect based on a potential for risk using adverse event reports turned in to the FDA, historical inspection data, reports of quality problems and public information. The FDA is working with state regulators to conduct the inspections
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Compounded Formulations From Retail Pharmacies Are Inaccurate in Respect to Potency Approximately 50% of the Time and Lack Content Uniformity Approximately 40% of the Time

NEW YORK, March 1, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq: VTUS) today announced the poster presentation of the results from its study investigating the quality of compounded topical 2% diltiazem hydrochloride formulations for anal fissures at the American Pharmacists Association Meeting currently underway in Los Angeles.
The use of topical 2% diltiazem hydrochloride for treating anal fissures has been explored in multiple clinical trials since 2000. In 2004, the Standard Practice Task Force of the American Society of Colon and Rectal Surgeons (ASCRS) published revised practice parameters for managing anal fissure and stated that topical formulations of calcium channel blockers may be appropriately used to treat anal fissure and accorded this practice parameter the highest level of evidence and highest grade of recommendation. Because no commercially manufactured version of topical 2% diltiazem has been approved by the US Food and Drug Administration (FDA) for treatment of anal fissure, colon and rectal surgeons, gastroenterologists, and other physicians who want to follow ASCRS practice parameters have to write prescriptions for a product that will be extemporaneously compounded by retail pharmacies. To examine the quality of compounded formulations of topical 2% diltiazem, Ventrus undertook a high-performance liquid chromatography (HPLC) analysis of preparations gathered from retail pharmacies in a metropolitan region.
A participating healthcare professional wrote 12 prescriptions, with 2 refills allowed per prescription, so that 3 prescriptions could be filled at each of 12 pharmacies (36 total refills) for compounded 2% diltiazem cream. The analysis included an assessment of potency (percentage of claim) and content uniformity, with sampling from 8 different pre-specified locations within the compounded formulation containers.
The United States Pharmacopoeia (USP) standard for potency is 90% to 115% of claim. Of the 36 preparations, 5 (13.89%) were supra-potent and 13 (36.11%) were sub-potent. The supra-potent prescriptions ranged in potency from 117.2% to 128.5% of claim, and the sub-potent prescriptions ranged in potency from 34.8% to 89.8% of claim. Fourteen (38.9%) preparations lacked content uniformity according to the USP standard.

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Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company: Healthpoint Ltd for ointment Xenaderm

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.

Click here to see the press release from the AG’s office.

Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.
According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.

To read the press release on the settlement from the DOJ, click here.

The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.
Responding to a Medicaid Audit.
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Pharmacist sentenced to 2 years Pa. steroids case

AP
PITTSBURGH — A pharmacist has been sentenced to 2½ years in federal prison after pleading guilty to helping a former Pittsburgh Steelers team doctor illegally distribute anabolic steroids in an investigation spun off from a national crackdown on the performance enhancing drugs.
William Sadowski, 47, of Robinson Township, pleaded guilty in November to conspiracy to possess with intent to distribute anabolic steroids and human growth hormones, or HGH, and was sentenced Tuesday by Senior U.S. District Judge Maurice Cohill Jr.
Sadowski has acknowledged helping Dr. Richard Rydze illegally distribute the body-building substances and other drugs used to prevent their negative side effects or, at least, mask their use. On Tuesday, the married father of two told the judge he let greed and profit cloud his judgment.
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After failures, DPH seeks 30 new staffers to boost inspection ability By Andy Metzger | State House News Service March 01, 2013

FITCHBURG — Interim Commissioner of Public Health Lauren Smith said Thursday that when she took over the depart­ment, following a deadly meningitis outbreak and the closure of a crime lab that shook confidence in the regulators, she engaged in a “frank and brutally honest introspection” with her staff.
One result of that introspection is a proposed $32 million budget increase at DPH, bringing the total amount to $549 million, which would allow for increased inspections and oversight of health care, hazardous material, and substance abuse facilities. That would fund 30 new ­positions and send $1 million to the Board of Registration in Pharmacy, Smith said.
“The public in general goes through its business, its daily life and appropriately assumes that the services, the restaurants, the beaches, the mammography machines, or everywhere it goes, that someone has looked at that, and someone has made sure that it’s OK,” said Smith. “Our role, as I see it, is to make sure that the public’s assumption that those things are well taken care of is actually true.”
The public’s confidence in pharmacies was shaken last year as hundreds fell ill around the country with ailments, includ­ing fungal meningitis, from tainted steroids produced at the New England Compounding Center in Framingham. That outbreak, which has sickened 714 and killed 48 by this week, led to changes within DPH, including unannounced inspections at the state’s 40 sterile compounding pharmacies. Many of those ­revealed that the alleged lack of proper protocols at the Framingham pharmacy was not unique.
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