With the next user fee agreement negotiations underway, device makers are not keen on a substantial hike in fee volumes. Nonetheless, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, has proposed a total product life cycle (TPLC) advisory function for the next user fee agreement, something he said would bring more predictability to industry and allow the agency to interact much more routinely with device makers.
The FDA’s breakthrough devices program encodes a number of policy objectives for the agency, but industry might see the program principally as a vector for faster time to market. However, Janice Hogan, partner at Hogan Lovells US LLP, said device makers might want to consider that the greater benefit is reducing regulatory uncertainty, not beating the typical FDA review clock.
The FDA’s legal authority to regulate lab-developed tests (LDTs) has come into question on several occasions in a number of venues, and the issue is enjoying new life yet again thanks to more activity on Capitol Hill. While two competing pieces of legislation are back in play, the most critical question may be whether the FDA has any authority left at all after the August 2020 rescission letter from the Department of Health and Human Services.
A grueling day of congressional questions and accusations isn’t the end of a U.S. House Oversight Committee investigation into Abbvie Inc.’s pricing of blockbuster drugs Humira and Imbruvica.
Despite support from a wide range of stakeholders and bipartisan congressional support, the U.S. CMS has suspended implementation of the Medicare Coverage of Innovative Technology (MCIT) rule through Dec. 15, 2021. CMS argued that most of the approved or cleared breakthrough devices are already covered through existing payment mechanisms, but the delay opens the door to any one of multiple possible legislative solution, such as follow-on legislation to the 21st Century Cures Act.
The U.S. Health Resources and Services Administration (HRSA) ordered six drug companies May 17 to immediately resume providing 340B discounts to contract pharmacies without restrictions and to credit or refund overcharges stemming from those restrictions.
It looks like the two biosimilars referencing Amgen Inc.’s Enbrel (etanercept) will have to wait out the rest of the decade before launching in the U.S. The U.S. Supreme Court declined May 17 to hear Sandoz Inc.’s appeal of last year’s split Federal Circuit ruling affirming the validity of two patents protecting etanercept and its manufacturing methods
To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is geared toward developing COVID-19 drugs, the FDA said it expects master protocols to continue to play an important role in addressing the public health needs in future pandemics.
As part of its ongoing investigation into what it considers excessive price increases for some prescription drugs, the U.S. House Oversight Committee plans to put Abbvie Inc. CEO and Chairman Richard Gonzalez on the hot seat May 18 for a grilling on the company’s pricing of Humira and Imbruvica.
The latest report by the Medicare Payment Advisory Commission (MedPAC) includes an advisory about unfettered expansion of telehealth, but the commission also said that expanded access to ambulatory surgical centers could trim per-procedure spending, which in some instances is about half the fee paid for a given procedure when performed in a hospital outpatient department (HOPD).
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