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Rx Price Reforms: PART II: Whom are We Trying to Help, Anyhow?
I recently staked my claim that the Class of 2019 drug price reforms don’t include much new, effective, or even particularly pretty. It’s simple to throw stones at the proposals, but more challenging to build – and pass – alternatives that are helpful, feasible and affordable. The bizarre fact in this case is, alternatives have…
Read MoreRx Price Reforms: PART I: We Already KNOW what DOESN’T Work
When it comes to controlling costs for prescription drugs, everybody wants to get into the act this year. With so many clowns trying to steal the show, I expect nothing good will result. Yes, I’m typically cynical, but in Washington the cynic is often the realist. So forgive my being the one to point out,…
Read MoreHealthcare: Nine Ways a Federal Slowdown Hits the Little Guy
THIS WAS AN OLD BLOG POST FROM THE LAST SET OF FEDERAL SHUTDOWNS. SOMEHOW SEEMS RELEVANT IN 2018-19, SO I’M REPOSTING. “THE MORE THINGS CHANGE, THE MORE THEY STAY THE SAME.” Nine Ways a Federal Slowdown Hits the Little Guy The press seems drunk with stories outlining the risks of the Sequester, the Debt…
Read MoreBiosimilars: Reading FDA’s Tea Leaves
When biosimilars hit FDA, what will be the review criteria? Everyone cares, since so much is at stake. The market for generic versions of eligible biologics might soon reach $20 bil. Recent FDA actions might hint at the new era. In a Citizen Petition for Lovenox (Aventis), FDA shared its review guidelines for approving a generic.…
Read MoreFrom the President’s Desk
Those who know me will raise an eyebrow, even drop a jaw, at hearing of the evolution from solo-based consulting into a more formal firm. The obvious question is, why. Those who know me well seem too shocked to even ask. I love working solo: diverse work, flexibility for home time with our special kids,…
Read MoreMedical Devices: Next on the Chopping Block?
Folks may just waking up to the impact that health reform will have on their businesses. Not just doctors or hospitals, and not the health care sector alone. Everybody. But even industries active in the pre-passage negotiations might find themselves blindsided by regulatory developments both within health reform and beyond. One such group may be…
Read MoreDIALYSIS: Above All, Do No Harm
Every few years, a new industry becomes the apparent victim of Medicare’s regulatory wrath. First, the power scooter market, then the eye surgeons, then power scooters again. The latest proposed cuts in ESRD – big cuts, in case the world of dialysis isn’t your regular thing – give some the impression that dialysis clinics are…
Read MoreMedical Apps: FDA Forgets the ‘RH’ Factor, takes a ‘D’
Medical Apps: FDA Forgets the RH Factor, takes a D. This week, FDA finally gave us much ado about nothing – its official word on regulating medical “apps” for machines like smartphones. What? You didn’t realize iPhone apps could be medical devices under FDA’s jurisdiction? Today’s apps market offers very, very medical apps including some…
Read MoreThe Conversation” on New Drug Pricing: Are We There Yet? Part I: Policy perspectives on Sovaldi and other Hepatitis C drugs
We all know that someday, the US will need to tackle a long-avoided national “conversation” on healthcare… the one Like the kid in the back seat, I wonder, “Are we there yet?” This time, it seems hepatitis C drugs like Sovaldi are bringing us… really close. Learning why we’re close but not there, requires…
Read MoreSolvaldi and “The Conversation” on New Drug Pricing: Are We There Yet? (Part II – Sovaldi and the Hepatitis C marketplace, 2014)
We all know that someday, the US will need to tackle a long-avoided national “Conversation” on healthcare… the one that comes when the price of a new drug outstrips the economy’s ability to cover. Like the kid in the back seat, I wonder, “Are we there yet?” This time, it seems hepatitis C drugs like…
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