CMS: enrollment hits 1.6M in 2 weeks | Trump to roll out 2 final rules to lower drug prices | House bill closes Orphan Drug Act loophole
November 20, 2020
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Featured Story
The latest figures from the CMS show that 1.6 million consumers signed up for health coverage through the federally run exchange in the first two weeks of open enrollment this year. Among this year's enrollees, 343,628 are new to the exchange.
Full Story: FierceHealthcare (11/19) 
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Legislative & Regulatory News
The Trump administration plans to release two final rules on prescription drugs, according to a senior administration official. One would ban drug rebates in Medicare, and the other would align prices paid by Medicare for certain drugs with those paid in other countries.
Full Story: The Wall Street Journal (tiered subscription model) (11/19),  MedPage Today (free registration) (11/21) 
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Drug Industry Spotlight
The House unanimously passed a bill that would require drugmakers seeking an orphan drug designation to demonstrate that they would be unable to recover R&D costs through US sales within 12 years. Drugmakers have been accused of using a loophole in the Orphan Drug Act that allows them to seek orphan designation for existing drugs.
Full Story: FiercePharma (11/19) 
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The FDA has released 21 revised and 13 new product-specific draft guidelines designed to promote the development of generic drugs, bringing the total number of such guidelines issued by the agency to 1,974. The guidelines explain the FDA's expectations for the studies required to prove the equivalence of a generic drug to a reference-listed drug.
Full Story: Regulatory Focus (11/18) 
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The World Health Organization does not recommend the use of Gilead Sciences' antiviral drug remdesivir for hospitalized patients with COVID-19, regardless of severity, "because there is currently no evidence that it improves survival or the need for ventilation," the WHO's Guideline Development Group said in a statement. Meanwhile, the FDA granted emergency use authorization for a combination of remdesivir and baricitinib for hospitalized patients with COVID-19 who need supplemental oxygen or who are on a ventilator or receiving extracorporeal membrane oxygenation.
Full Story: Regulatory Focus (11/19) 
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PCMA is the national association representing America's pharmacy benefit managers (PBMs), which administer prescription drug plans for 266 million Americans with health coverage provided through Fortune 500 employers, health insurance plans, labor unions, and Medicare Part D. PCMA is dedicated to enhancing the proven tools and techniques pioneered by PBMs that generate savings and access for consumers and payors.

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