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It’s been a busy week at BIO. Today, a positive court decision regarding 340B, a recap of BIO’s clinical trial diversity roundtable, and how you can weigh in on the impact of the Inflation Reduction Act’s drug pricing provisions. (794 words, 3 minutes, 58 seconds) |
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Court rules against HHS on 340B contract pharmacies |
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The Third Circuit Court of Appeals ruled Monday that drug manufacturers can limit the number of contract pharmacies providers use under the 340B drug discount program—a step in the right direction toward refocusing the program on its intended goals.
Catch me up—what’s 340B? The federal 340B Drug Pricing Program was intended to help hospitals provide access to outpatient prescription drugs and other services to uninsured and vulnerable patients.
How did we get to court? In recent years, the use of contract pharmacies by hospitals exploded, leading to unprecedented growth in the program—and statutorily prohibited “duplicate discounts,” as we reported last year. So, pharmaceutical companies began limiting 340B sales to contract pharmacies.
The case: HHS argued that hospitals should be able to use unlimited contract pharmacies; the pharmaceutical companies (including BIO members) sued. On Monday, the court rejected HHS’s claim, saying Congress—not HHS—sets the terms of the program.
What they’re saying: “Statutory silences, like awkward silences, tempt speech. But courts must resist the urge to fill in words that Congress left out. The Department of Health and Human Services claims that drug makers must deliver certain discounted drugs wherever and to whomever a buyer demands. But the relevant law says nothing about such duties. So HHS’s efforts to enforce its interpretation against the drug makers here are unlawful,” says the court opinion.
BIO’s take: “The court indicated clearly that Congress could not have intended for the program to grow without any significant guardrails on usage, and appropriately reigned in the practice of using unlimited networks of contract pharmacies by hospitals and other covered providers,” explained BIO’s Chief Policy Officer John Murphy. “This is a step in the right direction of redirecting the focus of the 340B program as it was intended: an important and limited program designed to provide access to discounted novel products so community providers caring for the most vulnerable in society can provide access to treatments and health care services for the population they serve.”
The next steps: Similar cases are pending, and HHS could appeal. But this unanimous ruling is a good start, especially since this appeals court ruling included bipartisan appointees (two Democrat appointees and one Republican appointee). |
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Tell us how the Inflation Reduction Act will impact your R&D |
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The Inflation Reduction Act (IRA) passed last year contains drug pricing provisions that will start taking effect next year. BIO, in partnership with BioCentury, is collecting input on how companies think the legislation will impact their drug development decisions—click here to take the survey and ensure your voice is heard. |
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BIO workshops policy on clinical trial diversity |
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BIO’s Clinical Trial Diversity Roundtable yesterday brought together the Food and Drug Administration (FDA), industry leaders, and patient groups to begin implementing the clinical trial diversity provisions of the 2022 omnibus spending package—here’s a recap.
What’s in the omnibus? Sections 3601-3604 cover clinical trial diversity, including requirements for sponsors to develop and implement diversity action plans and for the FDA to consult with sponsors and other stakeholders to convene public workshops on increasing enrollment of historically underrepresented populations in trials.
Taking action: The goal of yesterday’s roundtable was to develop action plans for using data to improve trial diversity and ensuring diversity among the people running the trials.
This has been a priority for BIO—one of the few organizations providing real assistance in drafting the law’s clinical trial diversity language, Aisling McDonough, Chief of Staff for U.S. Rep. Anna Eshoo (D-CA), said during the roundtable.
Why it matters: “Black African Americans make up 43% of the lupus population but only 14% of all clinical trial participants” for lupus therapies, said Joy Buie of the Lupus Foundation of America, while other participants discussed scientific and equity reasons for improving diversity.
What’s next: The FDA must use plans such as those developed by the roundtable to ensure diversity in clinical trials and report on progress, per the omnibus.
“BIO is working hard to continue to advance our diversity agenda,” said BIO Chief Science Officer Dr. Cartier Esham, explaining that yesterday’s roundtable was the second in a series of BIO summits on clinical trial diversity. |
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President Biden’s Wednesday: Meeting House Speaker Kevin McCarthy to discuss the debt ceiling, with no major progress expected, per The New York Times. Later, meeting with the White House Competition Council for a progress update, then holding an official ceremony to say goodbye to outgoing chief of staff Ron Klain and welcome his replacement, Jeff Zients.
What’s Happening on Capitol Hill: The House is set to consider legislation to hasten the end of the COVID-19 public health emergency. Although President Biden said the emergency will expire May 11, POLITICO says Republicans see the vote as a way to pressure for earlier expiration of pandemic assistance programs. USDA Trade Undersecretary Alexis Taylor will be among the witnesses at the Senate Agriculture Committee’s first Farm Bill hearing. |
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