Archive for October 2018
Biosimilars: 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…
Read MoreEyes on the Prize: It’s Not the Approval, It’s the Reimbursement
Dear Friends: I apologize for falling behind in sharing any new blogposts in some time. I suppose everyone needs a 2015 Resolution, and mine is to commit to a more regular schedule. Many of you have confronted, hundreds of times, the policy issue that slapped me in the face at the end of the year.…
Read More