The Weekly Roundup

March 10, 2017 | Pamela Youngberg Dickson

The US and the EU announced a mutual agreement to recognize one another’s good manufacturing practices in pharmaceutical facilities, a step that is expected to reduce costs and enable regulators to devote more resources to other areas of the world where the supply chain might face greater risk. The move will “help ensure that American patients have access to safe, effective, and high-quality drugs," said Dara Corrigan, FDA's associate commissioner for global regulatory policy.

Meanwhile, at the Capitol, the FDA is without a head—albeit perhaps for just a short while longer. Bloomberg is reporting that Scott Gottlieb, who served under W’s administration, is a favorite for the head post. The current White House leadership has maintained its campaign position that the agency is too slow and the approval process burdensome. And the current favorite Gottlieb has deep industry experience and has taken a strong position on lowering costs by updating the approval process and speeding generic drug competitors to market.

On the flip side, the FDA points to significant reductions to its median time-to-approval—from 26.9 to 10.1 months between 1993 and 2016, with some drugs moving through the process more quickly. Even some in pharma are concerned about the impact of radical overhaul of the agency. The push-and-pull is not likely to quiet soon. Even the 21st Century Cures Act, passed last year with wide bipartisan support, had detractors aplenty saying both that it had gone too far and not far enough.

One thing is certain: the question, “How fast is fast enough?” is likely to continue to be a tough nut to crack. 

Here are few other stories that might be of interest:

  • They like us; they really like us. Three reasons USP supports provider status for pharmacists.
  • The sword has a double edge. A recent study of telehealth demonstrates increased access and increased cost.   
  • Last state standing. Will Missouri finally enact a prescription drug monitoring program?
  • Tsk. Tsk. Audit of prescription drug plans reveals insurers are still figuring out how to comply with Medicare Part D rules. 
  • Got game? Enjoy this twist on March Madness to root for the best in health and science innovation.   

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FDAMedicare Telemedicine

Pamela Youngberg Dickson

Before she came to Smart-Fill, Pamela developed marketing strategy and content for a range of technology start-ups and large-cap enterprises. Outside the office, she's into gardening, renaissance history, the Big Ten, and exploring the great outdoors.