CER Daily Newsfeed

Experts Say Federal Drug Pricing Program Has Been Abused, Misused

(11/13, Thelma Grimes, The Denver Gazette) reports “...[National Pharmaceutical Council chief science officer Jonathan Campbell] said patients might not be positively affected by 340B when there is a ‘buy low, sell high’ approach to patient care. ‘Buy low, sell high means that payers are paying the highest amount,’ Campbell said. ‘Often an unrelated amount for medicines. And those concerns are that employers are not receiving the discounts.’ Patients and employers are footing the bill for overbilling to the tune of $5 billion, Campbell said.” Subscription Required

Post-Approval R&D Is Critical for Fighting Cancer. The IRA Makes it More Difficult.

(11/13, Andrew Powaleny, PhRMA Blog) comments “...Under the IRA, medicines can be selected for price setting early in their lifecycle. For small molecule medicines – which make up a majority of cancer medicines that receive FDA approval – selection can occur just seven years after FDA approval. And post-approval R&D decisions are impacted even before selection, as the Health Affairs study warns...The Health Affairs study – along with a new study by the National Pharmaceutical Council – are the latest to highlight the critical role post-approval R&D plays in improving outcomes for patients and the unintended consequences of the IRA.” Full

J&J Suit May Force Incoming Trump HHS To Quickly Take Stance On 340B Rebate Dispute

(11/13, Gabrielle Wanneh, InsideHealthPolicy) reports “...The incoming Trump administration will need to decide whether to defend the Biden HRSA’s stance or agree with J&J. Trump’s 2024 campaign website included no mention of 340B, so it’s unclear what the next administration’s stance will be on this and other actions drug makers have taken to address problems impacting them in the 340B program, like contract pharmacy restrictions. But actions taken by the previous Trump administration show Trump’s main concerns may still lie with 340B hospitals, and he may look to reform the 340B program beyond the narrower disputes over J&J’s rebate plan and drug makers’ efforts to restrict the number of contract pharmacies that can provide discounted drugs.” Subscription Required

Republican Sweep Creates Smoother Path For Biopharma Policy Priorities

(11/13, Cathy Kelly, Pink Sheet) reports “...With the Republicans gaining control of the House of Representatives on November 13,, along with the Senate and White House following the November 5, elections, the new majority could help biopharma achieve key legislative priorities, such as 340B outpatient drug discount program reform as well as revision or even repeal of the drug pricing provisions in the Inflation Reduction Act.” Subscription Required

Woodcock Warns of ‘Excessive Worship Of The RCT,’ Pushes New Drug Approval Pathway

(11/13, Sarah Karlin-Smith, Pink Sheet) reports “...In the second part of the Pink Sheet’s interview with the former senior FDA official, Woodcock says her push to create a rare disease drug approval pathway that wouldn’t require a randomized controlled trial will not return the agency to ‘an anecdote standard’ or cause a downward creep in the evidentiary standard for approval.” Subscription Required

Fierce Health Payer Summit, Day 2: 'All In' on Value-Based Care

(11/14, Emma Beavins, Fierce Healthcare) reports “...Azar said the new Trump administration will likely be more favorable to value-based care, though it’s not a sure fire initiative. He said the future of value-based care will depend on the personnel that president-elect Donald Trump hires in the Office of Management and Budget, the West Wing and to lead HHS and CMS.” Full