News & Views: 5/3 - 5/9

May 10, 2022

House Energy and Commerce leaders introduced a bipartisan legislative package to reauthorize the FDA User Fees, including PDUFA, GDUFA, and BsUFA.

In addition to reauthorization, the package included provisions that address the accelerated approval pathway, clinical trial diversity, generic drug competition, and the drug supply chain. The package combines key Democrat and Republican policies, including accelerated approval reform. As proposed, the bill would give the FDA the authority to require post-market studies to begin at the time the manufacturer is granted accelerated approval, as there is currently little regulation surrounding the timing of post-market studies for accelerated approval drugs and empowers the FDA to use standard dispute resolution processes to expediate the withdrawal of an accelerated approval drug. The provision also includes labeling requirements that explains the drug’s accelerated approval to patients and calls for the FDA to issue guidance on surrogate endpoint selection. The package is scheduled to go through markup in the Health Subcommittee this week (5/11) to be able to get through Congress by the end of August, according to the press release. To read the full package, click here.

The Senate Commerce held a subcommittee hearing on PBM practices that have contributed to rising drug costs.

While only Subcommittee Chairman Blumenthal (D-CT), Ranking Member Blackburn (R-TN), and Committee Chair Cantwell (D-WA) were in attendance, there was general consensus that PBMs have been able to operate in the dark for too long. Blumenthal repeatedly asked PCMA President and CEO, JC Scott, if PCMA would support an FTC study on PBM activity to better understand their role in high drug prices, to which JC Scott reported that PCMA is not against working with FTC if needed. The senators also discussed restoring the FTC’s ability to fine manufacturers for anticompetitive behavior. To review the hearing, click here.

House Republicans released their Healthy Future Task Force plans.

If Republicans take the House at the mid-terms, they plan to pass their own drug pricing plan. The plan includes proposals to pass rebates along to patients at the pharmacy counter and expand the use of the accelerated approval pathway.  The plan does include bipartisan initiatives, such as creating an out-of-pocket cap and prohibiting pay-for-delay deals but does not compare to the major reform that Democrats have been trying to pass. To read the taskforce recommendations, click here.

340B Health released a survey on the impact that contract pharmacy restrictions has on the 340B program.

The survey examines the impact that manufacturers restricting their 340B participation has had on over 500 member hospitals. The annualized impact of restrictions has more than doubled since the end of 2021 alone, costing disproportionate share hospitals, rural referral centers, and sole community hospitals $2.2M and critical access hospitals $0.45M. To review the full survey, click here.

AARP found that prices for most top Part D drugs have already increased in 2022.

The report examined the top 100 brand name drugs with highest Part D spending in 2020. Between December 2021 and the end of January 2022, 75 of the drugs had list price increases, while none decreased. The average percent change was 5.2%, with 12 drug list prices being increasing by at least 7.0%. To read the full report, click here.

CIDSA Experts in the News

Ge Bai, Mariana Socal, and their colleagues from Texas Christian University School of Business and Johns Hopkins University analyzed individual prescription drug plan cost trends in a JAMA research letter. The researchers analyzed insurers’ medical loss ratio filings of 2,200 health plans that reported positive prescription drug rebates. The median pre-rebate drug cost per covered life was found to increase by 68.1% for individual plans, 44.9% for small group plans, and 23.9% for large group plans annually. To read the entire letter, click here.

Stacie Dusetzina spoke with reporters at NPR on the recent Medicare drug plan price increases. Dusetzina discussed that while manufacturers typically increase prices in January and July, they are able to increase their list prices at any time. While plans and PBMs receive discounts on these price increases, the savings are generally funneled to slow premium growth rather than reducing an individual’s out-of-pocket cost. To read the full article, click here.

Stacie Dusetzina spoke with reporters at Bloomberg Law on the potential impact of ARPA-H. Dusetzina spoke to how if the government has a greater role in drug development and subsequent approval, access to those drugs should also be greater. To read the entire article, click here.  

Ameet Sarpatwari and colleagues from Harvard University detailed FDA approvals that went against advisory committee votes in a Health Affairs journal article. The researchers reviewed all FDA advisory committee referrals from 2010-2021. Over the study period, approved drugs that had been referred to an advisory committee for review decreased from 55% to 6%. To read the full article, click here.

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