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Sarah M. Canberg

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Vermont Attorney General’s Office Posts Final “Guide to Vermont’s Prescribed Products Gift Ban and Disclosure Law for 2013 Disclosures”

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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The Supreme Court to Determine Whether Pharmaceutical Sales Representatives are Entitled to Overtime Pay

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

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Zyrtec Went Viral on YouTube, Will Others Follow?

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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Supreme Court to Hear Cases on Health Care Reform Law

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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Ain’t No Sunshine in CMS’ Response

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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FDA Blueprint: Gateway, Not a Barrier to Innovation

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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CMS Called to Task for Missing October 1st Deadline

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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Goodbye DDMAC, Hello OPDP

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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Kansas Prescription Monitoring Program: What do Wholesalers Have to do With It?

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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West Virginia Jumps on Bandwagon to Modify Disclosure Requirements

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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Biotechnology Industry Pushing for Progressive Changes within FDA

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

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Comments on Draft Guidance due to FDA by September 12, 2011

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

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Companies Petition for a Clear Line between Permitted and Prohibited Off-Label Communications

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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Legislators in Maine and Massachusetts Make Noise About Disclosure and Gift Ban Laws

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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Maryland Board of Pharmacy Stages a Limited Retreat From Its Definition of “Manufacturer” For Licensing Purposes

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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Vermont Marketing Disclosure Reports Move from Fiscal Year to Calendar Year

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

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Proposed 2 Year Ban on DTC Advertising – Dead on Arrival?

Since the FDA’s issuance of industry guidance for direct-to-consumer (“DTC”) advertising in 1999, Congress and other industry watchdogs have repeatedly voiced concerns about the impact of DTC advertising. One concern is its impact on the cost of drugs, specifically that DTC advertising encourages a broader use of the drug than... Continue reading

Posted Jun 6, 2011 at Pharmaspective

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FTC Takes Another Bite at the Generics Anti-Trust Litigation Apple

Last week, the Federal Trade Commission (“FTC”) filed an amicus brief with the U.S. Court of Appeals for the Third Circuit in the In Re K-Dur Antitrust Litigation. A class of direct purchasers initiated this case challenging the settlement between Schering-Plough, owner of key patent for high blood pressure medication... Continue reading

Posted May 26, 2011 at Pharmaspective

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YouTube: The New “Homemade Bread”

In prior post, “Bad Ads, Beware!,” we queried if we should expect to see a rise in Bad Ad complaints. It looks like the answer to our query may be “yes.” On May 5, 2011, DDMAC issued an Untitled Letter to Warner Chilcott (US), LLC, resulting from a complaint submitted... Continue reading

Posted May 18, 2011 at Pharmaspective

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Data Mining Before the Supreme Court Today

In 2007, Vermont enacted a law to restrict how a doctor’s prescribing data may be used, specifically placing limits on the use of such data for marketing purposes. IMS Health Inc., a company that sells the prescribing information to pharmaceutical industry clients, joined with PhRMA and others, to challenge the... Continue reading

Posted Apr 26, 2011 at Pharmaspective

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Bad Ads, Beware!

With the debut of FDA's Bad Ad Program in May 2010, FDA looked to healthcare providers to become a new offensive against misleading prescription drug promotion. Simultaneous to the launch of the Bad Ad Program, a Reuter's Article reported the intent of the Bad Ad Program was to “increase regulators... Continue reading

Posted Apr 25, 2011 at Pharmaspective

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UK Leaps Ahead of US and Issues Informal Guidance on Digital Communication

FDA recently announced yet another delay in the release of its first draft guidance to pharmaceutical companies regarding the use of social media. In the meantime, the UK regulator, Prescription Medicines Code of Practice Authority (“PMCPA”) released an informal guidance on digital communication. Rather than develop new rules, the PMCPA... Continue reading

Posted Apr 11, 2011 at Pharmaspective

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Possible Consequences of a Government Shutdown – Could it Impact Patient Access to Prescription Medications?

By: Anne E. Wagstaff As tomorrow’s midnight deadline approaches, it appears more and more likely that Congress will be unable to agree on the 2011 budget before the federal government is forced to shut down. One of the many unintended and lesser known consequences of a lengthy government shutdown is... Continue reading

Posted Apr 7, 2011 at Pharmaspective

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Who Knew Drugs Could be the Answer to the Federal Deficit?

In a prior post, “Will the ‘New Normal’ Affect the Life Sciences Industry," we queried whether the life sciences industry would become a target during the on-going government budgetary crisis. President Obama’s recently released Budget of the United States Government for Fiscal Year 2012 includes provisions targeting the Department of... Continue reading

Posted Apr 7, 2011 at Pharmaspective

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Compliance Audit: Risky or a Necessity?

As the government continues its heightened scrutiny and increased investigations of allegations of off-label marketing of drugs and violations of the False Claims Act, the Anti-Kickback Statute, and the Federal Food, Drug and Cosmetic Act, it is not surprising that many pharmaceutical and medical device manufacturers contemplate seeking outside help... Continue reading

Posted Mar 24, 2011 at Pharmaspective

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