Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses trends in recent congressional discussions about the high cost of prescription drugs.
What are some of the trends you have identified in recent congressional hearings on drug pricing?
I think that the big issue is drug pricing. I mean, that’s been swirling around since you’ve had the Martin Shkreli issues; I think that’s the driving force. I think it’s interesting to see what the administration’s response has been. Typical congressional response has been, “Let’s start importing drugs from Canada.” The FDA hates that idea, I think not just from a safety point of view, but also it really undercuts the FDA’s authority. Or the other issue is, “Let’s just let the government negotiate prices with companies,” and companies hate that.
Congress and the administration I think have been looking for a middle ground, and the middle ground is, “Let’s fix this by competition. Let’s get more generics approved more quickly, let’s try and get rid of the impediments that are holding that up.”
The same [is happening] with biosimilars: “Let’s try and get those approved more quickly. Are there ways to approve biosimilars that are interchangeable?” That’s why you saw the FDA come out with its draft guidance document, and I know companies are looking to do that. There’s been a lot of activity at the FDA on that.
To me, it’s been interesting to see how the congressional focus on drug pricing has really been reflected in agency policies to try to speed up generics, to address it through competition and market-based solutions rather than the typical standby: “Let’s go to Canada, or let’s tell the companies what the price is going to be.”