Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, August 28, 2014
Another Compounding Sales Representative Job Opening-Tulsa, Oklahoma
Compounding Pharmaceutical Representative - Tulsa
15 hours ago - ... http://apothecarytulsa.com Email all resumes. Company Overview: Lees Specialty Compounding Inc. - The ESOP parent company of The Apothecary Shoppe.
FDA Animal Veterinary Draft Guidance for Industry - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations –
Draft Guidance for Industry - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations – http://www.fda.gov/downloads/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM411451. pdf
Wednesday, August 27, 2014
PhRMA jumps into Integrilin off-label case, free-speech arguments at the ready
It was inevitable. When a U.S. circuit court decided the First Amendment protected a pharma sales rep from off-label marketing charges, the free-speech arguments had to multiply. And they have, in cases across the country, testing that Second Circuit decision in other regions.
The latest: PhRMA jumped into a California False Claims Act (FCA) case, with a friend-of-the-court brief defending Millennium Pharmaceuticals, Schering-Plough and Merck's right to talk up unapproved uses of the clot-fighting drug Integrilin.
It's a wisely chosen target: The case, filed by former Millennium sales rep Frank Solis, hinges on journal articles that the company allegedly distributed to doctors, along with letters summarizing the studies. Schering-Plough copromoted Integrilin with Millennium, and Merck ($MRK) bought Schering in 2009.
http://www.fiercepharmamarketing.com/story/phrma-jumps-integrilin-label-case-free-speech-arguments-ready/2014-08-27?utm_medium=nl&utm_source=internal
The latest: PhRMA jumped into a California False Claims Act (FCA) case, with a friend-of-the-court brief defending Millennium Pharmaceuticals, Schering-Plough and Merck's right to talk up unapproved uses of the clot-fighting drug Integrilin.
It's a wisely chosen target: The case, filed by former Millennium sales rep Frank Solis, hinges on journal articles that the company allegedly distributed to doctors, along with letters summarizing the studies. Schering-Plough copromoted Integrilin with Millennium, and Merck ($MRK) bought Schering in 2009.
http://www.fiercepharmamarketing.com/story/phrma-jumps-integrilin-label-case-free-speech-arguments-ready/2014-08-27?utm_medium=nl&utm_source=internal
Horse Doping: Jones: "Either we eliminate the problem, or the problem is going to eliminate us"
But given the network of state regulatory bodies, how would you envision The Jockey Club’s role working? And where would it get the authority to actually take punitive actions other than pulling a horse’s registration, for example?
“We need to strengthen the penalties for doping horses, for example, and then you need to give that job of enforcement to somebody like the United States Anti-Doping Agency [USADA]. If you have USADA in control of that under the larger umbrella of The Jockey Club, it would seem to me that you would have your best opportunity of doing this properly. But what’s happened in the horse industry is that there’s been too much wrist-slapping when rules are broken and not enough penalties applied for these broken rules.”
read more here
Question of the Day August 27, 2014 How many traditional compounding pharmacies (those not registered as outsourcing facilities with the FDA) are fully complying with 503(A)? Should PBMs or insurance companies be reimbursing for drugs that are not in compliance with 503(A)? Should the insurance companies and hte PBMs report those compounding pharmacies that are not in compliance with the 503(a)?
Subscribe to:
Posts (Atom)