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What We're Reading: "Right-to-Try" Law Set; FDA to Speed Gene Therapies; Drug Pricing Analysis Finds Increases
The “right-to-try” bill heads to President Trump’s desk for signing after passing the House of Representatives; the FDA said certain gene therapies in development can qualify for quicker review, starting with hemophilia; brand-name drug makers have raised prices by double-digit percentages since 2012, with 47 drugs costing Medicare and Medicaid nearly $12 billion in 2016.
"Right-to-Try" Bill Headed for Trump's Signature
FDA Clears Quicker Path for Some Gene Therapies
The “right-to-try” bill heads to President Trump’s desk for signing after passing the House of Representatives for the second time by 250-169. The bill, which would allow terminally ill patients to bypass the FDA and request experimental drugs that have cleared phase 1 safety trials directly from drug companies, passed largely along party lines. The Senate passed the bill in August 2017, and the House approved its own version in March. That version was opposed less by medical groups, but then the legislation stalled. House leaders decided to pass the Senate version instead, The Washington Post reported.The FDA said certain gene therapies in development can qualify for quicker review, STAT reported. Commissioner Scott Gottlieb, MD, said that hemophilia is the first disease the FDA will target with its new policy. Under the new policy, gene therapies for hemophilia could be evaluated based on whether the therapy increases clotting proteins in the blood, regardless of whether the therapy actually causes the patient to bleed less.
Brand-Name Pharmaceuticals Had Double-Digit Price Hikes Over 4 Years
Brand-name drug makers blamed by the Trump administration for potentially stalling generic competition have raised prices by double-digit percentages since 2012, with 47 drugs costing Medicare and Medicaid nearly $12 billion in 2016, Kaiser Health News reported. Kaiser’s analysis said the spending totals don’t include rebates, which pharmaceutical companies return to the government. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014.
Urticaria Diagnosis Challenged by Overlapping Pruritic Skin Conditions
April 23rd 2025Urticaria is complicated to diagnose by its symptomatic overlap with other skin conditions and the frequent misclassification in literature of distinct pathologies like vasculitic urticaria and bullous pemphigus.
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New Research Challenges Assumptions About Hospital-Physician Integration, Medicare Patient Mix
April 22nd 2025On this episode of Managed Care Cast, Brady Post, PhD, lead author of a study published in the April 2025 issue of The American Journal of Managed Care®, challenges the claim that hospital-employed physicians serve a more complex patient mix.
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Personalized Care Key as Tirzepatide Use Expands Rapidly
April 15th 2025Using commercial insurance claims data and the US launch of tirzepatide as their dividing point, John Ostrominski, MD, Harvard Medical School, and his team studied trends in the use of both glucose-lowering and weight-lowering medications, comparing outcomes between adults with and without type 2 diabetes.
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ACOs’ Focus on Rooting Out Fraud Aligns With CMS Vision Under Oz
April 23rd 2025Accountable care organizations (ACOs) are increasingly playing the role of data sleuths as they identify and report trends of anomalous billing in hopes of salvaging their shared savings. This mission dovetails with that of CMS, which under the new administration plans to prioritize rooting out fraud, waste, and abuse.
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