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How the drug industry keeps winning

What if I told you the Sen. Thom Tillis campaign account was graced with nearly $20,000 in personal donations from drug industry CEOs and other top industry brass on Valentine’s Day? You’d think it was some cheesy made-for-TV movie about D.C.’s power elite, right? Well, it’s not: It’s just one of the many salacious details Lev and I dug up while reporting a big new story about how, despite all the inflammatory rhetoric, the drug industry is still winning in Washington.

It’s chock full of never-reported details about how the drug industry is quietly — and in some cases not so quietly — still lobbying their way to victory after victory on Capitol Hill. Check it out here.

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Speaking of the drug industry winning … about those Senate drug pricing packages

Major health policy initiatives in two key Senate committees hit roadblocks last week, STAT has learned. The first snag came from Democrats on the Senate Finance Committee, who penned a letter to committee leaders signaling they would oppose bipartisan legislation they feel doesn’t go far enough.

“Instead of outsourcing negotiations to other countries, the Secretary of HHS should guarantee and enforce reasonable prices” here in the U.S., states the letter, dated July 11 and obtained by STAT. It’s a shot both at President Trump’s proposal to enact an international price index as well as a warning to Sen. Ron Wyden (D-Ore.), the committee’s top Democrat, that his colleagues’ eventual goal is empowering Medicare to negotiate for drug prices. The only committee Democrat not to sign the letter, incidentally: Sen. Bob Menendez, who represents the biopharma hotbed of New Jersey.

Meanwhile, three lobbyists and Republican aides confirmed that GOP senators have placed at least 11 “holds” on health-cost legislation currently before the Senate HELP Committee. Republican HELP staffers cast the holdup as a typical part of Majority Leader Mitch McConnell’s process, though lobbyists said the degree of opposition made it unlikely that the bill could pass a floor vote before the upcoming August recess. The bill currently includes a ban on “spread pricing,” which refers to a PBM tactic to charge more for drugs than it costs to acquire them, and a provision requiring drug companies to justify decisions to hike their prices higher than 10% in a 12-month span.

STAT scooplet: Could there be a true generic insulin?

Rep. Mike Kelly (R-Pa.) wants answers from the FDA on why there isn’t a generic insulin. In a new letter sent this morning to Acting FDA Commissioner Ned Sharpless, which was shared exclusively with STAT, he’s taking issue with an obscure 2017 guidance that lays out how generic drug makers can copy certain peptide products. More specifically, he wants to know why insulin, which is a peptide, wasn’t included in that guidance.

Generic drugs can be automatically switched for brand drugs at the pharmacy counter, but that’s not been possible for insulins. Instead of filing generic drug applications for cheaper insulins (known in FDA-speak as ANDAs), drug makers have been forced to file applications called 505(b)(2)s, which don’t allow the same type of pharmacy substitution. Kelly says that’s part of the reason insulin prices are so high.

“As a diabetic who uses insulin every day, I understand their challenges personally,” Kelly told me in a written statement. “If American innovators can produce a real generic alternative that brings insulin prices down, then we need to explore that option. From the looks of it, the technology is there but an FDA pathway is not. Americans deserve to know why.”

The situation is all the more pressing given insulins will soon be regulated biologics, meaning it’ll be even harder for pharmacists to substitute them in the drugstore. That pending transition has caused some hand-wringing in Congress, so much so that Sen. Dick Durbin (D-Ill.) introduced a bill last week requiring FDA to continue reviewing insulin applications even after that timeline. (Durbin’s bill, however, would not solve the issue perplexing Kelly.)

A new boost for Trump’s international price index

The advocacy group Patients for Affordable Drugs Now is re-upping its ad campaign supporting one of the last White House drug pricing proposals still standing, it announced this morning.

The group had previously run a $1 million ad campaign in favor of the proposal. And now that the Trump administration has faced setbacks on two other ideas — losing in court on its TV price disclosure requirement and withdrawing its vaunted “rebate rule” — IPI is among the final initiatives the White House could pursue on its own.

P4AD Now knows where to find a captive audience. The ads will air online and on just one television show: “Fox and Friends,” the most widely publicized part of the president’s morning routine.

A broader addiction treatment bill than you’d expect

Sen. Jeanne Shaheen’s bill to address the addiction crisis, introduced on Friday, at first blush sounded like any number of legislative attempts and administration programs aimed addressing the epidemic. But our colleague Andrew Joseph points out that the New Hampshire Democrat targeted her bill not just at opioids — reflecting the growing recognition that methamphetamine and cocaine misuse are burgeoning issues that need a response.

It’s an element of the addiction crisis that policymakers, advocates, and the media have sometimes overlooked. While overdose deaths from opioids still far outnumber those from other drugs, they appear to be cresting as those from methamphetamine and cocaine rise. Plus, experts say, people often mix different types of drugs (as well as alcohol), so a broader approach needs to be taken.

Among other things, Shaheen’s $63 billion bill would boost Medicaid reimbursement rates for addiction treatment, provide funding for mental health services for law enforcement, and promote safer medication prescribing after surgery. And while it would increase funding for State Opioid Response grants, it would also introduce new flexibility into the program so that the resources could be used to treat substance use disorders generally, not just opioid use disorders.

Lev Facher contributed reporting. 

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