PHARMACEUTICALS
Crossing the Political Divide: Senate HELP Committee Hearings on Drug Prices
Katie Gudiksen, Senior Health Policy Researcher December 22, 2017
On December 12, 2017, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a bipartisan hearing on the cost of prescription drugs. This hearing was the third in a series of Senate HELP committee meetings on drug prices and was held in response to the release of the National Academies of Science, Engineering, and Medicine’s report entitled “Making Medicines Affordable: A National Imperative”. At the hearing, Senator Murray (D-WA), ranking member of the Senate Health Committee, noted that the price of prescription drugs was one of the …
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Orphan Drug Act: Fostering Innovation or Abuse?
Source Fellow December 12, 2017
By: Grace Lee, Research Fellow Introduction Luke Whitbeck, 2, was born with Gaucher disease, a rare genetic disorder.[1] Before using the pharmaceutical drug Cerezyme,[2] “Luke frequently ran high fevers, tired easily, and was skinny all over, except his belly stuck out like a bowling ball.”[3] Fortunately, the drug effectively helped Luke manage his symptoms. His mom reports that “Luke now spends days playing with his big brother.”[4] Despite the bill of good health, the Whitbecks and their insurer struggle to pay for the high cost of the drug, which amounts …
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Has the Problem of Increasing Drug Prices Really Passed?
Katie Gudiksen, Senior Health Policy Researcher November 22, 2017
The rate of increase in spending on pharmaceuticals is declining, according to a Quintiles-IMS Health report from May of 2017.[1] In 2016, the rate of increase in spending on pharmaceuticals was only 4.8% on a net basis (i.e. including rebates and discounts) – less than half that in 2014 and 2015, although it remains much higher than inflation. Express Scripts, one of the largest Pharmacy Benefit Managers (PBMs) in the U.S., reports that in their employer-based plans, per-person spending on prescription drugs increased just 3.8%, much lower than previous years.[2] …
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Academic Articles & Reports Roundup: October 2017
Sammy Chang, Health Policy Researcher November 1, 2017
Happy November! In this Roundup, we cover five articles from October. The topics this month include: (1) pharma-tribal cooperation and the patent system, (2) Medicare subpopulations with the highest preventable spending, (3) privacy protections in All-Payer Claims Database legislation, (4) medical spending on autism spectrum disorder, and (5) a game theory model to understand hospital competition. Pharma-Tribal Cooperation Undermines the Patent System The Association for Accessible Medicine paper Patent-Assignment Transactions Between Brand-Name Drug Companies and Native American Tribes Will Undermine A Healthy Patent System and Harm Patients arises from Allergen’s …
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Drug Money Part 4 – The Return of the CREATES Act: Fourth Time’s a Charm?
Katie Gudiksen, Senior Health Policy Researcher October 25, 2017
The Creating and Restoring Equal Access to Equivalent Samples Act (or CREATES Act) is the latest attempt by Congress to intervene to prevent anticompetitive behavior in the pharmaceutical industry. The intention of the CREATES Act is “to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.”[1] A bipartisan group of Senators introduced the most recent version of the CREATES Act into the current session of Congress on April 27, 2017, and Sen. …
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Can Policies at the FDA Help Curb Rising Drug Prices?
Katie Gudiksen, Senior Health Policy Researcher October 20, 2017
In a recent blog post, Scott Gottlieb, the Commissioner of the Food and Drug Administration (FDA), signaled that the FDA would take a more proactive approach to approving drugs to attempt to increase competition in the pharmaceutical market. In the post, Gottlieb acknowledged that the “FDA doesn’t control drug pricing, [but] our policies do affect competition in the market. This is the nexus of our current efforts on drug pricing.” Details of the Announcement In his blog post, Gottlieb describes two draft guidances to aid in the approval of generic …
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Governor Brown Signs Groundbreaking Drug Price Transparency Bill
Katie Gudiksen, Senior Health Policy Researcher October 13, 2017
What does the California Drug Transparency Bill (S.B. 17) Actually Do? On Monday, October 9, Governor Jerry Brown signed S.B. 17, the California Drug Transparency Bill into law. Brown and the bill’s supporters said the new California law should prompt action in other states and could be used by Congress as a blueprint to help rein in rising drug costs. The Mercury News called the bill “the nation’s most comprehensive law aimed at shining a light on prescription drug prices.” The law becomes effective on Jan 1, 2018 and seeks …
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Pfizer files Groundbreaking Lawsuit against J&J Alleging Anticompetitive Practices
Katie Gudiksen, Senior Health Policy Researcher September 28, 2017
Pfizer filed a lawsuit on Wednesday, September 20, alleging Johnson &|Johnson (J&J) made “exclusionary contracts” with insurers regarding their drug Remicade. Remicade (infliximab) is biologic medication that must be administered via IV infusion. In contrast to most drugs that are chemically synthesized, biologic medications are large biological molecules or complex mixtures that are not easily duplicated. Remicade (infliximab) is a monoclonal antibody. As biologic medications cannot be exactly duplicated, the FDA process for approving biosimilars is similar but not identical to the Abbreviated New Drug Application (ANDA) process for small molecule generic drugs. …
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Drug Money Part 3: How do International Drug-Pricing Policies compare to U.S. Policies?
Katie Gudiksen, Senior Health Policy Researcher September 27, 2017
Introduction As discussed in earlier Drug Money Issue Briefs, spending on pharmaceuticals is a large and growing concern in the United States and the world. In 2013, the countries in the Organization for Economic Co-operation and Development (OECD) spent $800 billion, accounting for nearly 20% of all health expenditures.[1] Even among OECD countries, however, the U.S. stands out for large spending on pharmaceuticals. In 2014, the U.S. spent $1,112 per capita on pharmaceuticals – more than double the average spending for the countries in the OECD and ~40% more than …
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Academic Articles & Reports Roundup: September 2017
Source Fellow September 27, 2017
By: Katie Beyer, Student Fellow Happy October! In this Roundup of articles from the past month, we cover four articles from September. The topics this month include 1) actual R&D costs for single cancer pharmaceuticals|2) policy solutions beyond antitrust to promote competition and regulate consolidation|3) reasons behind market exclusivity for prescription drugs|and 4) state policy recommendations curbing healthcare consolidation efforts. Actual R&D Costs for Single Cancer Pharmaceuticals A 2017 Tufts University Center for Study of Drug Development and Research estimated the total cost of research and development (R&D) spending is $2.7 …
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