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Ingrid A. Pelzer
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By Albert E. Cuccinello On April 15th, April 16th, and April 22nd, the Centers for Medicare and Medicaid Services (CMS) will hold webinars to provide a regional-level overview of the final rules implementing the Sunshine Act, and the Open Payments program. The target audience for the webinars is association and... Continue reading
Posted Mar 27, 2014 at Pharmaspective
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By Kerry Miele Pursuant to the District of Columbia’s prescription drug marketing cost reporting law [D.C. CODE § 48-833.01], manufacturers and labelers of prescription drugs that employ, direct, or utilize marketing representatives in D.C. are required to submit an annual report disclosing certain prescription drug marketing costs. The report must... Continue reading
Posted Mar 20, 2014 at Pharmaspective
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By Brianna Pirmann In an effort to assist reporting entities with Phase 1 registration and data submission, the Centers for Medicare and Medicaid Services (CMS) has posted on its Open Payments website a new table that provides a side-by-side comparison of Phases 1 and 2. Some of the topics covered... Continue reading
Posted Mar 18, 2014 at Pharmaspective
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By Nancy A. Henshaw In its continuing efforts to provide a "safe, convenient, and responsible means of disposing of prescription drugs," the federal Drug Enforcement Administration (DEA) has scheduled its eighth National Prescription Drug Take-Back Day for Saturday, April 26, 2014. The DEA held its first Prescription Drug Take-Back event... Continue reading
Posted Mar 10, 2014 at Pharmaspective
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By Natasha Bobo On November 27, 2013, President Obama signed into law the Drug Quality and Security Act, which amends the Federal Food, Drug, and Cosmetic Act. Title II of this law, also known as the Drug Supply Chain Security Act (Act), establishes a timeline for entities involved in the... Continue reading
Posted Mar 7, 2014 at Pharmaspective
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By Kim C. Capone The Office of Inspector General (OIG) has released its 2014 Work Plan. The Work Plan summarizes activities OIG plans to pursue with respect to the U.S. Department of Health and Human Services (HHS) programs and operations. The Work Plan can be an important resource for identifying... Continue reading
Posted Mar 6, 2014 at Pharmaspective
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By Kim C. Capone On February 28, 2014, the U.S. Food and Drug Administration (FDA) released the revised draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices." The draft guidance recommends practices for pharmaceutical and medical device manufacturers when disseminating scientific and medical literature... Continue reading
Posted Mar 5, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) The Centers for Medicare and Medicaid Services (CMS) has been busy this month. All in preparation for the first set of disclosure reports as required by the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care... Continue reading
Posted Feb 25, 2014 at Pharmaspective
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By Ingrid A. Pelzer (@IngridPelzerPLS) On November 27, 2013, President Obama signed into law the Drug Quality and Security Act, which amends the Federal Food, Drug, and Cosmetic Act. Title II of this law, also known as the Drug Supply Chain Security Act (Act), establishes a timeline for entities involved... Continue reading
Posted Feb 24, 2014 at Pharmaspective
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By Ingrid A. Pelzer The Vermont Attorney General's Office (AG's Office) is offering to accept a payment to the State in the amount of $10,000 per reporting period to settle failures to report under the Prescribed Products Gift Ban and Disclosure Law (Law) for prior reporting years. According to the... Continue reading
Posted Feb 21, 2014 at Pharmaspective
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By Ingrid A. Pelzer According to the Centers for Medicare and Medicaid Services (CMS) Open Payments program website, February 18, 2014, marked the first day for registration and data submission for applicable manufacturers and applicable group purchasing organizations (GPOs). CMS is implementing a two-phased approach for this first reporting year.... Continue reading
Posted Feb 20, 2014 at Pharmaspective
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By Natasha C. Bobo The Vermont Office of the Attorney General (AG’s Office) recently filed and posted on its website Assurances of Discontinuance executed by three manufacturers settling violations of Vermont’s Prescribed Products Gift Ban and Disclosure Law (Law). According to the Law, manufacturers of prescription drugs, biological products, and... Continue reading
Posted Feb 17, 2014 at Pharmaspective
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By Brianna Pirmann Vermont's Prescribed Products Gift Ban and Disclosure Law (Law) makes it unlawful for manufacturers of prescribed products and wholesale distributors of medical devices to offer or give any gift to a health care professional. On February 4, 2014, the Vermont General Assembly introduced House Bill 836 (HB... Continue reading
Posted Feb 12, 2014 at Pharmaspective
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By Ingrid A. Pelzer 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,” requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments... Continue reading
Posted Feb 7, 2014 at Pharmaspective
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By Ingrid A. Pelzer The Centers for Medicare and Medicaid Services (CMS) has denied requests to exclude the distribution of textbooks and scientific peer-reviewed medical journal materials from the reporting requirements under the Sunshine Act. According to the preamble of the final regulations, educational materials (including medical textbooks) provided to... Continue reading
Posted Jan 10, 2014 at Pharmaspective
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On November 27, 2013, President Obama signed House Bill 3204 (HR 3204), also known as the "Drug Quality and Security Act," which amends the Federal Food, Drug, and Cosmetic Act. Title II of HR 3204, also known as the "Drug Supply Chain Security Act,” establishes a timeline for entities involved... Continue reading
Posted Dec 3, 2013 at Pharmaspective
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Pursuant to Vermont’s Prescribed Product Disclosure Law [18 V.S.A. §§ 4631a, 4632] (Law), manufacturers of prescribed products are required to annually disclose to the Vermont Attorney General’s Office (AG’s Office) the value, nature, purpose, and recipient of any allowable expenditure or permitted gift by April 1 of each year. Additionally,... Continue reading
Posted Nov 26, 2013 at Pharmaspective
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By Grant Ostlund On November 4, 2013, the federal Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking placing Tramadol into Schedule IV of the Controlled Substances Act (CSA). This action comes after a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services,... Continue reading
Posted Nov 18, 2013 at Pharmaspective
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UPDATE - November 18, 2013: The U.S. Senate has passed HR 3204. The bill has been returned to the House of Representatives, and will be sent to President Obama for signature. On September 27, 2013, the United States House of Representatives introduced House Bill 3204 (HR 3204), also known as... Continue reading
Posted Nov 13, 2013 at Pharmaspective
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By Kim C. Capone On October 24, 2013, the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter to Sunovion Pharmaceuticals for misleading patient brochures regarding its drug, Brovana (arformoterol tartrate) Inhalation Solution. According to the Untitled Letter, the patient brochures are misleading because they... Continue reading
Posted Nov 4, 2013 at Pharmaspective
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By Rakan F. Ghubej 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 Nov 1, 2013 at Pharmaspective
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By 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 as the “Sunshine Act.”... Continue reading
Posted Oct 31, 2013 at Pharmaspective
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By Kim Capone In May 2010, the the Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) (formerly the Division of Drug Marketing, Advertising, and Communications) announced the launch of the Bad Ad Program “to help health care professionals recognize misleading prescription drug promotion and provide them with... Continue reading
Posted Oct 30, 2013 at Pharmaspective
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By Frank Minichetti 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 Oct 29, 2013 at Pharmaspective
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By Kerry Miele On June 20, 2013, the Board of Health (Board) in King County, Washington passed new Secure Medicine Return Regulations (Regulations), establishing a program to collect and properly dispose of unwanted medicines from local residents. This program will be funded and operated by drug manufacturers whose prescription and... Continue reading
Posted Oct 16, 2013 at Pharmaspective