Republican-led states seek to change how Medicaid works | MedPAC proposes payment hike, single incentive program for hospitals | More losartan tablets recalled due to possible carcinogen
March 18, 2019
FDLI SmartBrief
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Drugs & Biologics
Gottlieb: Drug R&D slow to act on FDA modernization efforts
Gottlieb: Drug R&D slow to act on FDA modernization efforts
Gottlieb (Chip Somodevilla/Getty Images)
Outgoing FDA Commissioner Scott Gottlieb chided drug developers and clinical research organizations for failing to take advantage of changes the agency has made to modernize the drug development and approval process and make it more efficient. "We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise," Gottlieb said.
Endpoints News (3/15) 
Republican-led states seek to change how Medicaid works
State governments led by Republicans are working with the Trump administration on changes to Medicaid programs that include adding work and drug-testing requirements and adopting capped or fixed funding. Seven states have been granted permission to implement work requirements and eight requests are being considered, while other states have been given approval to require copayments and to restrict benefits and eligibility.
The Wall Street Journal (tiered subscription model) (3/15) 
MedPAC proposes payment hike, single incentive program for hospitals
As part of its March report to Congress, the Medicare Payment Advisory Commission proposed increasing payments to acute-care hospitals by 2%, rather than the 2.8% hike expected under existing law, with the remaining 0.8% to be used to reward participants under a single quality incentive program. Amid concerns that hospitals are losing money under Medicare, the panel also proposed eliminating $1 billion in penalties incurred by hospitals annually under two penalty-only incentive programs and replacing the four current incentive programs with a single program.
Healthcare Finance (3/15),  Modern Healthcare (tiered subscription model) (3/15) 
More losartan tablets recalled due to possible carcinogen
Legacy Pharmaceutical Packaging is recalling an additional 43 lots of blood pressure drug losartan due to trace amounts of a possible carcinogen. This recall follows other recent recalls of losartan tablets for the presence of potential carcinogens.
United Press International (3/17) 
Medical Devices
Fresenius' fluid-management software nabs breakthrough status
Fresenius Medical Care's computer-assisted ultrafiltration control software, designed for improving fluid management in hemodialysis, has obtained breakthrough device designation from the FDA. The software is being developed for use in a dialysis machine embedded with intelligent diagnostics that can give computer-assisted recommendations for meeting target relative blood volume levels.
MassDevice (Boston) (3/15) 
BD's venous stent gets FDA approval
Becton Dickinson has obtained premarket approval from the FDA for its Venovo venous stent, which is intended for treating symptomatic nonthrombotic and post-thrombotic iliofemoral lesions.
FDAnews (3/15) 
Global Focus
MHRA orders investigation into paclitaxel-eluting devices for PAD
The UK's Medicines and Healthcare products Regulatory Agency has appointed an independent expert advisory group to investigate the safety of paclitaxel-eluting balloons and stents for peripheral arterial disease treatment by assessing a study that suggests a link between these devices and increased mortality risk to look for any evidence of a causal relationship. The devices will stay on the market while the investigation is conducted.
BioWorld MedTech (3/15) 
EMA opens at temporary Amsterdam headquarters
The European Medicines Agency has begun operating from its temporary Amsterdam headquarters and is expected to house almost 350 staff members there as of today. The agency expects to lose about a quarter of its employees due to the relocation.
FDAnews (3/18) 
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Food and Drug Law Institute (FDLI) Highlights
This Thursday: Food Enforcement and Compliance Conference | March 21, Washington, DC
This Thursday: Food Enforcement and Compliance Conference | March 21, Washington, DC
Hear from Keynote Speaker Frank Yiannas, Deputy Commissioner for Food Policy and Response, Office of the Commissioner, FDA, on the latest developments and issues in food enforcement and compliance. Other hot topics include current FDA and USDA/FSIS enforcement priorities, inspection policies, and recent enforcement actions involving alleged violations of food safety or labeling requirements. View Agenda
Polish Your Knowledge Pre-Conference: Introduction to Food Law and Regulation | March 19-20, Washington, DC
Polish Your Knowledge Pre-Conference: Introduction to Food Law and Regulation | March 19-20, Washington, DC
Explore the essentials of food law and regulation including pending regulations, food safety, food labeling, enforcement, and related issues. Case studies, hypotheticals, and ample time for discussion are provided. Register Now
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