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Ingrid A. Pelzer
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FDA Issues Draft Guidance to Help Companies Distinguish Between a Voluntary Medical Device Recall and a Product Enhancement
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By Laura C. Conway and Stephen C. Matthews On February 22, 2013, the Food and Drug Administration (FDA) issued a draft guidance entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” (Docket No. FDA-2013-D-0114) (Draft Guidance). The purpose of the Draft Guidance, according to FDA, is to... Continue reading
Posted May 23, 2013 at Pharmaspective
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CMS Is Accepting Comments on the Revised Templates for Data Collection and Submission of Reports Required by the Sunshine Act
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As previously reported on Pharmaspective, the Centers for Medicare and Medicaid Services (CMS) recently posted on its website revised templates for data collection and submission of reports required by the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly... Continue reading
Posted May 21, 2013 at Pharmaspective
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CMS Will Hold a Conference Call on Wednesday, May 22 to Discuss the National Physician Payment Transparency Program
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By Nancy A. Henshaw The Centers for Medicare and Medicaid Services (CMS) is continuing its efforts to inform interested parties on its National Physician Payment Transparency Program (Program). The Program implements the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care... Continue reading
Posted May 10, 2013 at Pharmaspective
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CMS Posts Revised Templates For Data Collection and Submission of Reports Required By the Sunshine Act
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By Rachael Garrison The Centers for Medicare and Medicaid Services (CMS) is continuing its efforts to quickly implement 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.” The Sunshine Act requires applicable... Continue reading
Posted May 8, 2013 at Pharmaspective
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CMS Publishes List of Teaching Hospitals Subject to Reporting Under the Sunshine Act
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By James E. Squier 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... Continue reading
Posted May 7, 2013 at Pharmaspective
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Musings From TEDMED 2013
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By Scott S. Liebman TEDMED is some creative combination of industry conference, Broadway production, nerd fest (me included), and health food store. The marble walls; the bright red carpet; the bronze bust of JFK at the Center for Performing Arts named in his honor: I felt like a tourist at... Continue reading
Posted Apr 23, 2013 at Pharmaspective
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CMS Is Accepting Comments on the Proposed Templates for Data Collection and Submission of Reports Required By the Sunshine Act
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By Monica Aurelien 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 Apr 4, 2013 at Pharmaspective
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OPDP Restructures Again: Promotional Review By Therapeutic Area Instead of Audience
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By Kim C. Capone According to a recent FDA announcement, the Office of Prescription Drug Promotion (OPDP) is restructuring its review process. OPDP currently reviews and analyzes its workload and review processes through two divisions: the Division of Consumer Drug Promotion, and the Division of Professional Drug Promotion. According to... Continue reading
Posted Mar 11, 2013 at Pharmaspective
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Minnesota Legislature Proposes to Repeal the Annual Disclosure Requirement for Wholesale Drug Distributors and Manufacturers
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By Jenna Gervasio 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 year. On March... Continue reading
Posted Mar 6, 2013 at Pharmaspective
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Understanding the Global Transparency Landscape: The Beginning of An Ongoing Journey
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By Brian P. Sharkey The quest for transparency in the relationships between life sciences companies and healthcare professionals has become a global movement, as companies are beset by a multitude of obligations designed to make public their interactions with their customers. Effectively managing those obligations while concurrently ensuring compliance with... Continue reading
Posted Feb 25, 2013 at Pharmaspective
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An Update From CMS on the Sunshine Act…Draft Templates!
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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." The final rule... Continue reading
Posted Feb 22, 2013 at Pharmaspective
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The Final Sunshine Act Regulations Have Been Published in Federal Register, and Will Become Effective on April 9, 2013
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By 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 as the "Sunshine Act."... Continue reading
Posted Feb 11, 2013 at Pharmaspective
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Sunshine Act: Indirect Payments: Reportable or Excluded?
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By Sarah Canberg All too often, a payment from an applicable manufacturer does not go directly to a physician or teaching hospital. Instead, the applicable manufacturer indirectly provides a payment to a covered recipient by making a payment to a third party that then transmits the payment to the covered... Continue reading
Posted Feb 8, 2013 at Pharmaspective
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Sunshine Act: Reporting Food, CME, and Research…Oh My!
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By Sarah Canberg As the life sciences industry continues to prepare to begin collecting data on payments and transfers of value to physicians and teaching hospitals on August 1, 2013, applicable manufacturers look for clarity and guidance on the scope of information to be reported. The final Sunshine Act regulations... Continue reading
Posted Feb 6, 2013 at Pharmaspective
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The Who and the What of the Sunshine Act Regulations
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By Sarah Canberg With the long awaited Sunshine Act final regulations in hand, members of the life sciences industry continue to sift through the 285 page regulatory tome to parse out the regulatory reporting requirements that resulted from Centers for Medicare & Medicaid Services’ (CMS) consideration of over 373 comments... Continue reading
Posted Feb 5, 2013 at Pharmaspective
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CMS Announces the Release of the Final Regulations Implementing the Sunshine Act...Finally!
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By Chrissy Bradshaw and Sarah Canberg On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) announced the much anticipated 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... Continue reading
Posted Feb 4, 2013 at Pharmaspective
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A Quick Observation Regarding the FDA and the Caronia Decision…
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By Kim C. Capone and Sarah M. Canberg On December 3, 2012, the United States Court of Appeals for the Second Circuit handed down its decision in U.S. v. Caronia, and ruled that the government cannot prosecute pharmaceutical manufacturers for speech promoting the lawful, off-label use of an FDA-approved drug.... Continue reading
Posted Feb 1, 2013 at Pharmaspective
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Dear White House Chief of Staff…Where Are The Final Regulations!?
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By Jenna Gervasio and Danielle Burke On January 22, 2013, Senator Charles Grassley, ranking Member of the U.S. Senate Committee on the Judiciary, sent a letter to the Honorable Jacob J. Lew, the White House Chief of Staff, expressing disappointment in the continued delay in implementing the “Sunshine Act” provisions... Continue reading
Posted Jan 23, 2013 at Pharmaspective
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The Minnesota Board of Pharmacy Will Not Require the Submission of Annual Disclosure Reports for the 2012 Calendar Year
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By Danielle Burke Minnesota law [Minn. Stat. § 151.47(f)] 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 year. The annual disclosure... Continue reading
Posted Jan 16, 2013 at Pharmaspective
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The National Physicians Alliance and the American Medical Student Association Request Full Implementation of the Sunshine Act
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By Monica Aurelien On January 3, 2013, the National Physicians Alliance (NPA) and the American Medical Student Association (AMSA) sent a joint letter to Jack Lew, the White House Chief of Staff, urging him to fully implement the “Sunshine Act” provisions of the Patient Protection and Affordable Care Act. In... Continue reading
Posted Jan 9, 2013 at Pharmaspective
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Second Circuit: Truthful Off-label Promotion of Prescription Drugs is Protected by the First Amendment
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By Laura C. Conway On December 3, 2012, the United States Court of Appeals for the Second Circuit ruled that a pharmaceutical sales representative could not be convicted for truthful off-label promotional statements made to physicians about a drug that had been approved by the FDA for other uses. United... Continue reading
Posted Dec 5, 2012 at Pharmaspective
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CMS Sends Final Regulations That Would Implement the Sunshine Act to the Office of Management and Budget
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By Danielle Burke On November 27, 2012, the Office of Management and Budget (OMB) received final regulations from the Centers for Medicare and Medicaid Services (CMS), which would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act. CMS... Continue reading
Posted Nov 28, 2012 at Pharmaspective
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Update: Massachusetts Bureau of Health Care Safety and Quality Requests Approval of Final Regulations to Implement Changes to the Pharmaceutical and Medical Device Manufacturer Conduct Law
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On September 19, 2012, the Massachusetts Department of Public Health (Department) posted emergency regulations to immediately implement recent changes to Massachusetts’ Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] (Law). The Law requires the Department to “adopt a standard marketing code of conduct for all pharmaceutical... Continue reading
Posted Nov 26, 2012 at Pharmaspective
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The American Medical Association Disapproves of CMS Tasking Implementation of the Sunshine Act to the Center for Program Integrity
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By Ingrid A. Pelzer In December 2011, the Centers for Medicare and Medicaid Services (CMS) issued a notice of proposed rulemaking announcing the publication of draft regulations that would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act,... Continue reading
Posted Nov 19, 2012 at Pharmaspective
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FDA to Industry: Stay Tuned to 2013 For Further Guidance On Federal Sample Disclosure Reporting
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By Frank Minichetti Section 6004 of the Patient Protection and Affordable Care Act (Act) requires manufacturers and authorized distributors of record (ADRs) to disclose information related to drug sample requests and distributions on or before April 1, 2012, and each year thereafter. Earlier this year, the Food and Drug Administration... Continue reading
Posted Sep 24, 2012 at Pharmaspective
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