Replies to post #105285 on Biotech Values

[jq1234]

I've seen little comment about what is an important topic.

Here is one from Pharmalot:

Last week, the FDA held its first open meeting about user fees for generic drug makers, an issue that has been around nearly 20 years. The session came as generics continue to grow in popularity – nearly 75 percent of prescription drug volume was generic last year – and the FDA grapples with an inability to approve drugs fast enough. However, the backlog appears to be less of a priority to the agency than having funds to conduct overseas plant inspections. Meanwhile, the generic industry is split – the usual trade group was there along with a new coalition representing a few big players, but Mylan Laboratories spoke for itself. And so we spoke with Ramsey Baghdadi of Prevision Policy, a healthcare analysis firm that provides insights to Concept Capital and The RPM Report, about his impressions of the discussion and what to expect next…

Pharmalot: How badly do generic drugmakers want those user fees?
Baghdadi: They definitely want them. They’ve rallied round the idea of predictable outcomes and reduced review times. They want the process to become reliable. To underscore their view, there were some numbers thrown around at the meeting - a 16-month average review time in 2006 for generic drug applications, on average, versus 26-plus months in 2009. This came up time and again. The second thing was the backlog of applications. The FDA acknowledged there are more than 2,000 pending applications right now and the industry is really focused on this. The industry believes the fees, if used as they want them used, would help alleviate those issues. They want applications getting attention so the backlog doesn’t grow any further. That’s a big concern. And they want to add a separate backlog fee and apply that only toward the backlog with older applications that are pending. So it’s a two-fold strategy.

Pharmalot: But you say the FDA seemed more interested in foreign plant inspections. Why is that?
Baghdadi: The crux of the whole situation, in my opinion, is that the FDA’s priority is money for inspections. I think for the FDA that this is really a drug safety issue. They know they’re lagging in these inspections and an increasing number are at foreign sites. (Center for Drug Evaluation & Research Director Janet) Woodcock talked about that in her presentation. As the FDA tried to explain it, it’s in everyone’s interest that the supply chain is safe. She stressed this a few times. There was the whole heparin incident, for instance. The message was that all it takes is one or two (such) cases for everyone’s favorable view to change of the generic industry. She wasn’t taking a whack at them. But she realizes it could become a gushing problem if they don’t do enough inspections to maintain the integrity of the supply chain. You know, the industry is getting more api’s (active pharmaceutical ingredients) from outside the US. Anyway, my main point is that it appears there are conflicting priorities in play.


Pharmalot: But why should any money for user fees then be allocated for inspections?
Baghdadi: Woodcock tried to make it clear that it’s in their best interest that all products are fully inspected by the FDA and has a stamp of approval. Yes, we can do other things (with the money), but inspections are important. I think her message to these companies was that it’s absolutely critical to their reputation right now – and the generic industry does have a good reputation, in so far as the numbers show greater use of these products all of the time.

Pharmalot: How do you think the generic drugmakers are going to react?
Baghdadi: I think, on the whole, that they seem ready to do this trade off. The one thing I would say is that Mylan stood apart from the other two industry groups – the Generic Pharmaceutical Association and the Generic Drug User Fee Coalition (which includes former GPhA members Teva Pharmaceuticals, Apotex, Hospira, and Perrigo Laboratories). But Mylan stood apart and proposed three separate fees - an establishment fee, a product fee, and an inspection fee. I think it may be hard to get a consensus initially, but I also think the process will be driven, in large part, by the coalition, since these are such large players. But if they don’t get a deal done, they could wind up with more oversight for inspections but without improved performance from the FDA and the predictable outcomes they want.

Pharmalot: There was also mention of patents. Why was that raised?
Baghdadi: I thought Mylan’s president, Heather Bresch, made quite a compelling argument that reducing review times doesn’t mean a lick to anybody if they can’t get their drugs to market if they are hindered by patent issues. Basically, she was saying there’s a disconnect between the review process and patent litigation. She mentioned Strattera. Mylan (which received approval to sell a generic in November 2009) still isn’t marketing its generic because there’s patent litigation. But even with paying user fees and faster approvals, she was saying they would still have to wait. But there was no real solution in terms of how you bring them together. They’re very leery of paying big fees and getting faster review times if their products still can’t get to market. But that’s a pretty complicated issue to untangle.

Pharmalot: Where to from here?
Baghdadi: The FDA is keeping the docket open for public comment. Starting in November, they’ll kick off negotiations and meet with the GPhA and the collation and other stakeholders. I think they’ll looks at PDUFA V as an endpoint – it’s a vehicle that makes a lot of sense. Assuming they can get a deal done, they’ll attach it to whatever PDUFA V is called. Of course, that assumes they get a deal done and it gets through Congress.

http://www.pharmalot.com/2010/09/will-generic-user-fees-ever-happen-ramsey-explains/

[DewDiligence]

Did anyone attend FDA Generic Drug User Fee meeting? I've seen little comment about what is an important topic.

This issue has been bouncing around for what seems like half a lifetime. Here’s an excerpt of a Washington Post article from almost five years ago (#msg-9563839):

Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s—pay "user fees" to finance new hires by the FDA. Today, user fees support about half the FDA staff that reviews new drug applications.

But the generic drug industry…leaders say they cannot reach consensus on whether to accept user fees.

Others argue that since the low cost of generics has broad benefits for the public, Congress should be willing to pay for added staffing.