340B transparency bill advances

A busy pre-holiday Thursday, with activity on 340B in the House yesterday and a look at why Congress must repeal the R&D amortization provision. Plus, BIO just announced a new keynote speaker at the BIO International Convention—we have the details. (665 words, 3 minutes, 19 seconds)

Breaking News: FDA Commissioner to keynote BIO International Convention

Dr. Robert Califf, Commissioner of the U.S. Food and Drug Administration (FDA), will be the keynote speaker on Day 3 of the 2023 BIO International Convention in Boston—here’s the scoop.

Why Dr. Califf? Dr. Califf has weathered a pandemic, attacks on the accelerated approval pathway, and an infant formula shortage. He’s made fighting misinformation a top priority, citing its spread as a contributing factor to a drop in life expectancy in the U.S. 

What they’re saying: “Scientific facts and data are at the heart of what we do in the biotech industry,” said BIO CEO Rachel King. “We are so pleased that Dr. Califf is joining us, as we Stand Up For Science and fight back against distortions and half-truths that can spread like wildfire in the age of social media.”  

The details: Dr. Califf will join BIO CEO Rachel King in a wide-ranging interview on Wednesday, June 7, at the BIO International Convention in Boston—click here for details and registration.

Get ready: Dr. Califf joined a recent episode of the I am BIO Podcast, in which he talked about the problem with misinformation—listen here.

340B transparency bill advances in the House

Legislation on 340B transparency and oversight moved forward in the House yesterday—here’s what happened. 

What happened: The House Energy & Commerce Committee marked up 19 bills yesterday, advancing several important health-related bills (with bipartisan support) that BIO’s been watching.

340B:H.R. 3290, sponsored by Rep. Larry Bucshon, M.D. (R-IN), would ensure transparency and oversight of the 340B program. The bill advanced with bipartisan support.

What they’re saying: “I’m a strong supporter of 340B. But we have seen some practices highlighted over the past year…that should provide sincere concern on behalf of this committee,” said Rep. Scott Peters (D-CA). “340 B is an important program. We have every right and responsibility to know where the money’s going. And I think that’s what this bill is about.”

Additional bills that advanced include:

• The Animal Drug User Fee Amendments of 2023 (H.R. 1418), sponsored by Reps. Greg Pence (R-IN) and Kim Schrier (D-WA).
• The PATIENT Act (H.R. 3561), a.k.a. the Promoting Access to Treatments and Increasing Extremely Needed Transparency (PATIENT) Act of 2023, sponsored by Reps. Cathy McMorris Rodgers (R-WA) and Frank Pallone Jr. (D-NJ). This bill would provide greater transparency and oversight of pharmacy benefit managers and ban spread pricing in Medicaid.
• The Medicaid VBPs for Patients (MVP) Act (H.R. 2666). The bill strengthens access to care, including cell and gene therapies, said Rep. Anna Eshoo (D-CA), and provides access to “the most innovative cures for Medicaid patients with uncurable conditions,” added Rep. Brett Guthrie (R-KY).

Catch up on what’s been happening with these bills.

Why Congress must repeal the R&D amortization provision

Legislation is on the table—here’s what BIO says about it.

Catch up: The 2017 Tax Cuts and Jobs Act (TCJA) changed the longstanding deduction for R&D expenditures to a mandatory five-year amortization for domestic R&D and a 15-year amortization for foreign R&D.The change went into effect calendar year 2022.

Why it matters: Unless Congress repeals this provision, there will be adverse effects on companies and industries—including that companies will no longer be able to use immediate expensing of R&D costs to invest in research, conduct clinical trials, or simply keep the lights on until they make their transformational discovery, explains Bio.News.

BIO’s take: ““The requirement that companies spread out expensing of R&D costs over several years is, essentially, a new tax on innovation, which threatens future transformational or even life-saving biotech breakthroughs,” BIO’s Chief Policy Officer John Murphy told Bio.News. 

BIO’s action: BIO sent a letter to congressional leadership urging the repeal of the R&D amortization provision and the passage of S.866/ H.R. 2673—the American Innovation and Jobs Act, in the Senate and the American Innovation and R&D Competitiveness Act in the House.

Read more at Bio.News.

President Biden’s Thursday: He’s expected to announce the nomination of General Charles Q. Brown, Jr. to serve as the next Chairman of the Joint Chiefs of Staff.

What’s Happening on Capitol Hill: Things are slowing down ahead of the holiday weekend.