Tuesday, September 30, 2014
Great Answer to the Open Records and Transparency Question of the Day
Yes--pharmacies should be subject to the same level of transparency to the public, and so should chemical repackagers, who proffer deals that result in pharmacies making larger profits than they would normally if they chose to dispense nationally authorized products. This alerts consumers and payers that there may be strong financial incentives influencing professional's specific therapeutic recommendations--a dose of "healthy skepticism" is warranted (see: http://www.healthyskepticism.org/global/).
But current lack of transparency is only one determinant clouding medical and pharmacy decision-making in the promotion-frenzied compounded drug marketplace that can lead to increased risk or unfair transfer and distribution of risk to patients and subsequently, payers. Where there are outright kick-backs for prescribing, compensation for pseudo-trials, or gradually elevating AWPs for ingredients, fraud and abuse must be identified and vigorously prosecuted.
But current lack of transparency is only one determinant clouding medical and pharmacy decision-making in the promotion-frenzied compounded drug marketplace that can lead to increased risk or unfair transfer and distribution of risk to patients and subsequently, payers. Where there are outright kick-backs for prescribing, compensation for pseudo-trials, or gradually elevating AWPs for ingredients, fraud and abuse must be identified and vigorously prosecuted.
Removal May Prove Difficult for Compounding Pharmacies
Like pharmaceutical and medical device manufacturers, it is not surprising that compounding pharmacies facing personal injury/products liability litigation prefer the typically more defense-friendly federal arena over the often more challenging (to put it mildly) state court system. But as today’s case demonstrates, that may not be the easiest path for compounders to follow.
The case is Cruz v. Preferred Homecare, 2014 U.S. Dist. LEXIS 132647 (D. Nev. Sep. 22, 2014) and it involves a horrific set of facts involving the death of a minor. The decedent was born with a condition known as gastroschisis which required she be treated with Total Parental Nutrition (“TPN”). Id. at *2. TPN is used for patients who cannot get sufficient nutrition through eating. It is a solution administered intravenously and contains a combination of sugar and carbohydrates, proteins, lipids, and electrolytes. In this case, decedent’s physician would prescribe TPN by designating both an overall volume and a specific percentage of each substance. Id. It was the job of the compounding pharmacist to calculate the percentages into grams. Id. The complaint alleges that in 2011 decedent received an overdose of dextrose causing her glucose levels to rise so high that she went into fatal cardiac arrest. Id. at *3.
continue to read Drug and Device Law Blog here
Reminder FDA Guidance Regarding Laboratory Developed Tests
October 2014
- Guidance for Industry and Staff: Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests
FDA CDER System of Records including those for compounded and unapproved drugs
F]CDER System of Record (PDF - 103KB) 
www.fda.gov/.../UCM416566.pdf
Food and Drug Administration
BREAKING: Open Payments website launches By Jaimy Lee Posted: September 30, 2014 - 1:45 pm ET
The federal government today launched a highly anticipated website detailing at least $3.5 billion in financial ties in a five-month period between medical device and drug companies and physicians and teaching hospitals.
The Open Payments website is the first public repository of national data describing financial relationships between industry and healthcare providers. Critics of these payments say these payments can inappropriately influence clinical decisions.
The database was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that was spearheaded by Sen. Chuck Grassley (R-Iowa).
The Open Payments website is the first public repository of national data describing financial relationships between industry and healthcare providers. Critics of these payments say these payments can inappropriately influence clinical decisions.
The database was required by the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that was spearheaded by Sen. Chuck Grassley (R-Iowa).
continue to read here
Morning Break: Pharma $$ to Docs Database Opens Published: Sep 30, 2014 By MedPage Today Staff
http://www.medpagetoday.com/PublicHealthPolicy/GeneralProfessionalIssues/47877?isalert=1&uun=g649657d2242R5784224u&utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news&xid=NL_breakingnews_2014-09-30
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