Tag Archives: Congress

The US Biotech Drug Pricing Challenge

by Tom Norton In the midst of the hue and cry last week over the public release of individual Medicare payments to physicians, I was surprised to read that one of Medicare’s most costly medical services is — ophthalmology.  According to the New York Times: “One of the most heavily reimbursed procedures — costing a […]
Posted in Biotech, Corporate Responsibility, Guest Blog, healthcare, Market Access, pricing, Strategy | Also tagged , , , , , , , | 1 Comment

The Sovaldi Case: Is American Biotech History About to Repeat Itself?

Recent Congressional investigations over the pricing scheme of Gilead’s much-heralded hepatitis C drug Sovaldi – and a decline in stocks across the biotech sector – rings a familiar bell, writes Tom Norton. Twenty years ago in May, US Senator Joe Lieberman carefully questioned biotech CEO Harry Penner of then Neurogen Corporation about why his company’s […]
Posted in Biotech, healthcare, leadership, Market Access, pricing, R&D, Sales, Strategy | Also tagged , , , , , , , , | 2 Comments

Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
Posted in compliance, Corporate Responsibility, E-Media, Emerging Markets, FDA, healthcare, Legal, Marketing, Medical Education, pricing, Regulatory, Sales, social media, Strategy | Also tagged , , , , , , , , , , , , , | Leave a comment

Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
Posted in Biotech, compliance, FDA, healthcare, Legal, People, Regulatory, Safety, Strategy | Also tagged , , , , , , , | 1 Comment

Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
Posted in FDA, Legal, Manufacturing, Regulatory, Safety, Strategy, Supply Chain, Technology | Also tagged , , , , , , , , , , , , | Leave a comment
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