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Sarah M. Canberg
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By: Sarah M. Canberg and Rakan F. Ghubej On October 1, 2013, pursuant to the French Public Health Code, LOI n 2011-2012 Du 29 Décembre 2011 Relative Au Renforcement De La Sécurité Sanitaire Du Médicament Et Des Produits De Santé (“French Sunshine Act”), seven (7) French National Councils publicly made... Continue reading
Posted Oct 10, 2013 at Pharmaspective
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By: Sarah M. Canberg and Jenna M. Gervasio On October 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) posted the 2014 Teaching Hospital List on its OPEN PAYMENTS website. The final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient... Continue reading
Posted Oct 7, 2013 at Pharmaspective
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By: Sarah M. Canberg and Brianna Pirmann On February 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to... Continue reading
Posted Aug 23, 2013 at Pharmaspective
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This Monday, August 5th, Porzio Life Science's Scott Liebman will begin #ACA150, a Twitter countdown of the last 150 days until the Patient Protection and Affordable Care Act's ("ACA") provisions become a real presence in over 316 million Americans' everyday lives. Despite political controversy, implementation of ACA is well underway.... Continue reading
Posted Aug 2, 2013 at Pharmaspective
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By: Sarah M. Canberg and Hiramella Deonarine On February 1, 2013, the Centers for Medicare and Medicaid Services ("CMS") announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to... Continue reading
Posted Jul 30, 2013 at Pharmaspective
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By: Kerry Miele On February 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.”... Continue reading
Posted Jul 24, 2013 at Pharmaspective
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By Kim Capone The Office of Prescription Drug Promotion (“OPDP”) of the Federal Drug Administration (“FDA”) issued ten enforcement letters in the first six months of 2013, far less than in recent years. All ten letters issued in the first half of 2013 were Untitled Letters or “notice of violation... Continue reading
Posted Jul 15, 2013 at Pharmaspective
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By Nancy Henshaw and Sarah Canberg On February 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as... Continue reading
Posted Jul 8, 2013 at Pharmaspective
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By Natasha Bobo and Danielle Burke Minnesota law [Minn. Stat. § 151.47(f)] currently requires wholesale drug distributors and manufacturers to report annually to the Minnesota Board of Pharmacy (“Board”) all "payments, honoraria, reimbursement or other compensation" permitted under the gift prohibition statute and provided to practitioners during the previous calendar... Continue reading
Posted Jun 28, 2013 at Pharmaspective
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By Hiramella Deonarine and Danielle Burke In an effort to help manufacturers comply with the requirements of Vermont's Prescribed Products Gift Ban and Disclosure Law (Law) and to provide additional guidance for expenditure reports due on April 1, 2014 (the 2013 calendar year), the Vermont Attorney General's Office (AG’s Office)... Continue reading
Posted Jan 3, 2013 at Pharmaspective
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By: Sandra González Since our previous post, Should Sales Representatives Be Entitled to Overtime Pay?, we have continued to track the circuit split between the Second and Ninth Circuits on the issue of whether pharmaceutical sales representatives are entitled to overtime-pay. The United States Court of Appeals for the Second... Continue reading
Posted Dec 5, 2011 at Pharmaspective
With the onset of the fall allergy season, Zyrtec made the bold decision to take its ad campaign viral with an interactive Choose-Your-Own-Adventure style video clip game, Parks Unleashed, on YouTube. This was uncharted territory for both YouTube and the pharmaceutical marketing industry. On September 5th, Zyrtec launched its Parks... Continue reading
Posted Nov 30, 2011 at Pharmaspective
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On November 14th, 2011, the Supreme Court announced in an order that it will hear arguments on three cases from the 11th Circuit challenging the constitutionality of the Patient Protection and Affordable Care Act (“ACA”): National Federation of Independent Business v. Kathleen Sebelius, Secretary of Health and Human Services, et... Continue reading
Posted Nov 21, 2011 at Pharmaspective
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By way of a scant, one-page letter dated October 28th, Centers for Medicare and Medicaid Services (“CMS”) finally issued a belated response to the letter co-signed by Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) that demanded answers from CMS for its failure to issue the Federal Physician Payment Sunshine... Continue reading
Posted Nov 11, 2011 at Pharmaspective
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In our prior post, “Biotechnology Industry Pushing for Progressive Changes within FDA,” we discussed one industry group’s proposals for changes within FDA aimed at improving and expediting the drug and biologics approval process. This month, FDA Commissioner Margaret Hamburg outlined FDA’s blueprints for changes within FDA to encourage biomedical innovation... Continue reading
Posted Oct 20, 2011 at Pharmaspective
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October 1st came and went with no word from the Centers for Medicare and Medicaid Services (“CMS”) regarding the long awaited Federal Physician Payments Sunshine Act (“Sunshine Act”) regulations. While many in the life sciences industry would have been shocked if CMS issued the regulations by the October 1st statutory... Continue reading
Posted Oct 5, 2011 at Pharmaspective
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Following an 18 month approval process, Director Janet Woodcock announced in an email to Center for Drug Evaluation and Research (“CDER”) staff on Monday, September 19th that the Division of Drug Marketing, Advertising and Communication (“DDMAC”) is now reorganized and elevated into the newly formed Office of Prescription Drug Promotion... Continue reading
Posted Sep 21, 2011 at Pharmaspective
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By: Elizabeth H. Kim and Frank Fazio Wholesale distributors shipping drugs into Kansas may have recently received a letter from the Kansas Board of Pharmacy ("Board") requesting monthly shipment lists of prescription drugs sold or distributed into the state. Why? Well, the letter notes that the request is part of... Continue reading
Posted Aug 9, 2011 at Pharmaspective
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As noted in prior posts, “Vermont Marketing Disclosure Reports Move from Fiscal Year to Calendar Year” and “Legislators in Maine and Massachusetts Make Noise About Disclosure and Gift Ban Laws,” we continue to see states with aggregate spend disclosure requirements proposing revisions to their existing requirements. Most recently, West Virginia’s... Continue reading
Posted Aug 5, 2011 at Pharmaspective
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At its annual meeting in June, the Biotechnology Industry Organization (“BIO”) discussed a wide range of suggested policy changes to effectuate change within FDA. BIO’s proposals focus on encouraging biotechnology innovation and bringing biologic drugs to patients on an expedited basis. One such proposal was for FDA to use a... Continue reading
Posted Jul 29, 2011 at Pharmaspective
On July 14, 2011, FDA issued a new draft guidance titled “In Vitro Companion Diagnostic Devices.” This draft guidance is intended to shed light on the agency’s policy for reviewing a companion diagnostic tests and the corresponding therapy. FDA intends for the guidance to assist sponsors in developing a safe... Continue reading
Posted Jul 19, 2011 at Pharmaspective
In the current heightened enforcement environment, life science companies continue to struggle to develop internal policies and practices regarding permissible off-label communications. CIAs issued to companies like Boston Scientific, Johnson & Johnson, Novartis, and Pfizer, all of which have entered into settlements to resolve allegations off-label promotion ranging from $22... Continue reading
Posted Jul 14, 2011 at Pharmaspective
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In a prior post, “Vermont Marketing Disclosure Reports Move from Fiscal Year to Calendar Year,” we queried whether any state would amend their marketing disclosure laws to allow the federal law to completely preempt the state requirements. While we have not seen any state legislature pass a bill to repeal... Continue reading
Posted Jul 8, 2011 at Pharmaspective
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By: Frank Fazio Any manufacturer or private label distributor that utilizes a contract manufacturing organization (CMO) can share horror stories about the year-end renewal of the Maryland distribution license. Prior to the December 31, 2010 renewal deadline, the board determined that only facilities that physically manufactured product and had an... Continue reading
Posted Jul 7, 2011 at Pharmaspective
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On May 26th, Governor Peter Shumlin signed Vermont Senate Bill 104 into law, which amends sections 4631a and 4632 of Vermont's Prescribed Products Gift Ban and Disclosure Law. Among other things, Senate Bill 104 shifts the reporting period for required marketing disclosures from the fiscal year to the calendar year.... Continue reading
Posted Jun 14, 2011 at Pharmaspective