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STAT Scooplet: Wendell Primus set to break his silence

House Speaker Nancy Pelosi’s health policy expert Wendell Primus is set to address a congressional drug pricing briefing Friday afternoon — his first public remarks since news broke that he has quietly been crafting the speaker’s own drug pricing plan. Primus has been in talks with the White House about his idea for using arbitration to negotiate the price of prescription drugs. And his efforts have single-handedly set off something of a drug-pricing-focused civil war in the Democratic Party between progressives, who hate Primus’ idea, and more moderate Democrats, who insist they’re open to all ideas to bring down drug prices.


A spokesperson for the Council For Affordable Health Coverage, which is holding the event in the Rayburn office building, told STAT Primus “will have the floor and can say whatever he wants.” Here’s hoping he decides to unveil Pelosi’s drug pricing plan … but either way, whatever he says will be carefully analyzed by every drug pricing wonk in town, eager for clues as to what her office is up to.

While Wendell is likely to steal the show on Friday, CAHC, a coalition largely made up of insurers, drug makers, and middlemen run out of the lobby group Horizon Government Affairs, is slated to push three policies: a cap on how much Medicare beneficiaries can pay for drugs in Medicare Part D, value-based payments for drugs, and increased use of real-time benefit tools.

PhRMA CEOs gather Thursday to talk strategy

PhRMA’s set to have its board meeting this Thursday, STAT has learned. These meetings are an opportunity for drug industry CEOs to get together and talk strategy, and you can bet drug pricing will be at the top of the meeting’s agenda. It’s also PhRMA’s opportunity to chat up influential lawmakers and staff. (STAT scooped that newly minted Sen. Mitt Romney (R-Utah) addressed the group’s last meeting.) We haven’t yet gotten wind of any interesting speakers at this week’s meeting, but you know where to reach me if you’ve got some intel!


What’s next on insulin in Washington

The FDA is holding a hearing on biosimilar insulin next Monday, May 13. If you’re an avid D.C. Diagnosis reader, you know this is a big issue, because it’s about how the FDA will regulate cheaper insulins beginning next year. (Right now, insulins are regulated as drugs and there’s no truly generic insulins.) Beginning in 2020, they’ll be classified as biologics, and copycat versions can come on the market as biosimilars.

That should be good news for patients desperate for cheaper insulins, but that transition has created a real headache for the drug companies who want to make copycat insulins. The biggest stressor: the fact that the FDA has said if an insulin application is pending at the time of the transition, the company will have to reapply under the biosimilar pathway. (For more: here’s my deep dive on this complicated regulatory jumble.)

Next week’s meeting is technically focused on what data the FDA should consider when reviewing biosimilar and interchangeable insulin products, but it’ll likely also be drug makers’ last shot to convince the FDA to rethink the contentious policy I just outlined. But after CDER Director Janet Woodcock’s remarks at last week’s FDLI conference, drug companies probably shouldn’t hold their breath.

“We are trying to minimize any actual impact on sponsors of this transition but we are required by law to make this transition and we are going to do it, and hopefully things will settle out after that,” she said during last week’s FDLI conference.

Woodcock added that she doesn’t think the policy will hurt drug companies, unless one decides to file a drug application — rather than biologic application — close to the 2020 deadline. “That’s going to be unfortunate,” she added.

If you like bickering about patents, boy, do I have a hearing for you

The Senate Judiciary Committee will take on the issue of drug patents today at 10 a.m. PhRMA’s general counsel Jim Stansel will share the dais with Patients For Affordable Drugs founder David Mitchell and frequent pharma critic Michael Carrier, who’s a professor at Rutgers. Spoiler alert: They disagree about the role patents play in high drug prices.

Stansel is planning to tell the committee that patents, generally, are not the problem. Per testimony shared with STAT, Stansel will say: “IP protections do not impede competition in the U.S.; rather, they drive companies to innovate by providing a degree of assurance that companies may earn a return on an otherwise risky and costly investment in R&D. Moreover, IP protections do not block, but instead can foster, the entry of new competitors to market during the term of the patent.”

Meanwhile, Carrier is likely to highlight the various ways he sees drug makers manipulating the IP system, and Mitchell is slated, in his characteristic fashion, to give PhRMA some bitter medicine. “My testimony will push back on the idea that patients won’t get the innovative drugs we need without paying high prices,” Mitchell told STAT. “As a cancer patient dependent on new drugs to stay alive, I know Big Pharma’s talking point is a lie.”

Also, keep an eye out for what PhRMA says on CREATES

It’s probably no surprise to drug pricing wonks that the buzzy generic competition bill known as the CREATES Act is going to come up at today’s hearing. It’s long been the talk around Washington that PhRMA, despite once vociferously opposing the bill, has softened in its opposition. But I couldn’t help noticing that Stansel is planning to take one last crack at changing the bill. His prepared testimony says the group wants the FDA to be more involved in mediating disputes between generics and brands, among other changes.

It’ll be interesting to see how PhRMA’s suggested changes are received, given the bill passed out of the Senate Judiciary Committee last term and already cleared the House Energy and Commerce and House Judiciary Committees this term.