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BIO explains why CMS overreach will impede innovation, and we look at how data can improve clinical trial diversity. (532 words, 2 minutes, 39 seconds) |
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BIO: CMS overreach will impede innovation |
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Centers for Medicare and Medicaid Services (CMS) efforts to use an overly broad definition of drugs eligible for price controls will disincentivize research into treatments patients need, says BIO in Bio.News.
The challenge: “CMS has argued that it can treat multiple different medicines as the same drug—even if the dosing is different, the indications are separate, and the patient populations are distinct—as long as all of those products share the same chemical compound,” says BIO's opinion piece at Bio.News.
Other regulators behave differently: “The Food and Drug Administration (FDA), for instance, requires different trials and entirely separate regulatory processes when drugmakers wish to use an existing compound for a new use and a new group of patients,” explains BIO.
The result: “Medicines may be exposed to price controls after only a few years on the market if they share an ingredient with a drug that was approved earlier. This will discourage companies from testing medicines for new uses,” says BIO.
The bottom line: “For generations, the biopharmaceutical ecosystem has been kept in balance by a simple understanding. New medicines are protected from competition and government price-setting for a period of time, after which generic competition can be unleashed. But CMS’ approach to the [Inflation Reduction Act] undermines this balance.” Read the article at Bio.News. |
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How data can improve clinical trial diversity |
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Collecting data on the race and ethnicity of clinical trial participants is essential to ensuring trials are equitable and reflect our diverse population, said industry leaders at the 2024 BIO International Convention.
Why it matters: “If you do not have this information,” said Carla Rodriguez-Watson, Research Director at Reagan-Udall Foundation for the FDA, “then we have a limited view into what that population distribution of disease is.”
Historical neglect: Women were denied access to clinical trials until the 1980s, and people of color have often been excluded from clinical trials for reasons like inherent bias, location, and cultural issues.
Data is the solution. Data on race, gender, and ethnicity of participants helps ensure all groups are properly represented, panelists said. They discussed initiatives by Amgen, the Reagan-Udall Foundation, and the Duke-Margolis Institute for Health Policy to improve data.
What they’re saying: “It’s critically important that we conduct studies that are truly representative of all patients who are suffering with the disease,” said panelist Darryl Sleep, M.D. of Amgen. “If we fail to do that, a large portion of the population that are really suffering with the illness will never be able to access that medicine because the data don’t exist.”
Read more at Bio.News.
Watch our interview with panelist Darryl Sleep, M.D., Head of Global Public Health at Amgen: |
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More Health News: The Washington Post: A rare, deadly bacterial infection is on the rise in Japan. What is STSS?
“A record number of cases of streptococcal toxic shock syndrome (STSS) in Japan this year has focused attention on the rare and potentially deadly bacterial infection. There have been 1,019 cases of STSS in the first six months of 2024, surpassing the total number recorded last year in the country.” |
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President Biden’s Thursday: Decamping to Camp David.
What’s Happening in Capitol Hill: The House is in recess. The Senate Health, Education, Labor & Pensions Committee has a hearing, The Crisis Facing Public School Teachers. |
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