About Katie Gudiksen, Senior Health Policy Researcher
Katie Gudiksen, Ph.D., is the Executive Editor for The Source on Healthcare Price and Competition. Dr. Gudiksen is an expert in healthcare reform and the drivers of healthcare costs, with a special interest in market consolidation and state policies to address market power. She has helped draft model legislation to improve state merger review processes and to prohibit anticompetitive terms in contracts between insurers and health systems. Her current work focuses on evaluating the options states have to restrict excessive provider prices, including cost-growth benchmarks and state public options.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 …
Continue Reading Download PDF
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 …
Continue Reading Download PDF
Source Shorts: Medicare Officially Kills Program to Pilot Pharmaceutical Payment Reform
Katie Gudiksen, Senior Health Policy Researcher October 4, 2017
The Centers for Medicaid and Medicare officially dropped any attempt to implement a pilot program that would change the way drugs were reimbursed under Medicare Part B. This pilot reform attempt has been on hold for more than a year, but CMS has now officially withdrawn it. How does Medicare Part B cover prescriptions? Medicare Part B only covers drugs that are administered in a doctor’s office or clinic, which are primarily intravenous and injectable drugs (the bulk of pharmaceuticals are covered under Medicare Part D and would not …
Continue Reading Download PDF
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. …
Continue Reading Download PDF
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 …
Continue Reading Download PDF
Allergan Makes Deal with Mohawk Nation to Avoid Patent Review Process
Katie Gudiksen, Senior Health Policy Researcher September 13, 2017
The tricks pharma companies use to protect endangered patents took an unexpected turn on Friday when Allergan transferred the rights to all of its patent on Restasis, a drug to treat chronic dry-eye, to the Saint Regis Mohawk tribe. The tribe will then grant Allergan exclusive licenses to the transferred patents. In exchange, the tribe will receive a $13.75 million upfront cash payment and up to $15 million in annual royalties from Restasis sales. Allergan was facing both a federal lawsuit filed in Texas challenging the Restasis patents and an …
Continue Reading Download PDF
Washington State AG files suit against Franciscan Health System
Katie Gudiksen, Senior Health Policy Researcher September 12, 2017
The Washington State AG filed suit to thwart and unwind Franciscan Health Systems (FHS) most recent expansion attempts alleging violation of both state and federal antitrust laws. In a rarely seen antitrust enforcement action, the Washington AG’s office is asking the court to unwind FHS’ 2016 acquisition of WestSound Orthopaedics for violation of Section 7 of the Clayton Act and the Washington Consumer Protection Act and several affiliation agreements from 2016 between The Doctors Clinic and FHS for violation of Section 1 of the Sherman Act and the Washington Consumer …
Continue Reading Download PDF
Health Affairs’ Special Issue: Market Concentration
Katie Gudiksen, Senior Health Policy Researcher September 11, 2017
Check out the latest issue of Health Affairs with a special focus on market concentration! Read some great articles from Source board members Thomas Greaney, Robert Berenson and other all-stars of healthcare price and competition.
Continue Reading Download PDF