On Wednesday, January 7, 2015, I attended the Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee meeting that discussed and recommended approval of the first biosimilar drug, called filgrastim, under the Biologics Price Competition and Innovation Act (BPCI).
Jonathan Gruber Goes to Washington
Most of you know about Jonathan Gruber. He is the Massachusetts Institute of Technology (MIT) economics professor that was hired as a consultant by the Obama administration to provide guidance on designing ObamaCare. He has often been called the “architect” of ObamaCare. What was his consulting fee just from the Department of Health and Human […]
Newt’s Very Bad Idea
Former House Speaker Newt Gingrich often comes up with ideas to change how the government works. One of his most recent suggestions has made a lot of people who care about property rights scratch their head. At a December 2, 2014 meeting of Academy of Managed Care Pharmacy executives, Speaker Gingrich was asked about the […]
Innovation = Jobs
Innovation creates jobs. That is the central premise of Jay Walker’s keynote address, “Making Innovation Work for America and Americans,” at the first meeting of the IP Dealmakers Forum on November 6, 2014. The forum linked investors together with intellectual property (IP) information and opportunities. Walker’s speech is particularly timely given the release on November […]
Blaming Republicans for Ebola: A Seedy Campaign Ploy
Less than two weeks after the first person with Ebola in the United States was admitted to Texas Health Presbyterian Hospital on September 30, 2014, Democrats and their allies began blaming Republicans for his plight and everything else connected with preventing and treating the disease.
See You In Court – Again
One of the things that is becoming more disturbing each day is how the Obama Administration is issuing a tsunami of regulations, interpretive rules, sub-regulatory guidance, executive orders, guidelines, and even divine proclamations on White House tissue paper (just kidding on that last one) that contradict, subvert, or circumvent the law. Even though I just […]
WHO Are You to Raise the Tobacco Tax?
Black-and-white images of soldiers abroad brandishing “victory cigars” in the fight against a cruel and oppressive enemy lit up television screens in homes across the nation, and “Smoke! Smoke! Smoke! (That Cigarette)” by Merle Travis was a national hit on the air waves. Cigarettes were an icon of glamor with a hint of rugged sophistication, and America was very much the land of the free and home of the brave during World War II.
Happy Anniversary Healthcare.gov
It is hard to believe that the online marketplaces, or exchanges, under the Affordable Care Act (ACA), better known as ObamaCare, are having their one year anniversary this month. It seems like only yesterday that the federal website, Healthcare.gov, which officially opened on October 1, 2014, crashed almost immediately. Only six people in the entire country were able to utilize the federal exchange on the first day and sign up for a plan.
The Medical Device Tax: A Vise On Innovation
Since the day of its passage in 2010, millions of Americans and hundreds of members of Congress have called for the repeal of the Patient Protect and Affordable Care Act (PPACA), more commonly referred to as the Affordable Care Act (ACA) or Obamacare. The House of Representatives has had 54 votes on bills that would have fully repealed, restructured broadly, or modified parts of Obamacare. Many of these bills received bi-partisan support; most have died in the Senate. One bill that is likely to pass in the Senate if it could get a vote would fully repeal the ACA’s 2.3 percent excise tax on medical device sales.
A Promising Proposal to Reduce Waste in Medicare
Now that members of Congress have returned from the August recess, they have several big-ticket items to accomplish before the legislative year comes to an end in December. One non-controversial item that could be taken up is the Protecting the Integrity of Medicare Act, which aims to reduce waste and fraud in Medicare.