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The legal tactics that drug manufacturers use to extend drug patents may be the big-gest impediment to lowering drug prices and to Congress acting on pricing. Until now, that is.
Will the new opioid abuse bill prove more effective than its predecessor? A plethora of provisions will have little impact on pharmacists and pharmaceuticals.
President Trump’s American Patients First plan to reduce drug prices has some innovative aspects but might face political roadblocks.
FDA guidance on outsourcing facilities and 503A pharmacies
Hospitals search for IV opioids
Upcoming Guidance Documents Will Spell Out What and How to Submit
White House report on drug prices is a detailed road map
CMS consideration of rebate overhaul elicits strong opinions
NIH starts to spend billions in Cures drug research money
CMS considering pharmacy counter discounts for Part D drugs in the future
As the door opens to more step therapy and indication-based formularies, P&T committees must walk a fine line between managing treatment costs and providing access to critical drugs.
P&T committees may soon have access to more than drug-label information as HHS considers implementing a safe harbor for value-based contracts between drug manufacturers and health insurers.
The FDA has made it easier for P&T committees to make formulary coverage decisions by expanding the health care economics information that drug manufacturers can provide to them.
CMS finalizes drastic 340B reimbursement cut for 2018
Hospitals press FCC to expand health care on the airwaves
FDA delays drug-tracking pilot programs
A significant change in tiering exceptions policy for Part D is coming in 2018
Drug companies breathe easier as PDUFA VI heads for approval
Drug companies worry about new FDA “totality of evidence” standard
FDA pleases no one with final guidance on biological and biosimilar naming
New FDA and GAO reports highlight compounding issues
21st Century Cures bill may lead to faster drug/device approvals
Over-the-counter products in line for user fee program
Medicare allows add-on payments to hospitals for some new products
Off-label drug bills are back on track but could run off the rails
Plan to settle 340B disputes is itself the focus of a dispute
Congress set to tackle biosimilar naming debate
Recent FDA compounding guidances raise hackles
HHS walks a middle ground in final nondiscrimination rule
CMS Medicare Part B reimbursement plan panned
CMS stands pat on exchange formulary standards
Tighter P&T committee rules proposed for NAIC model act.
Confusion, ire follow FDA interim policy on compounding.
340B guidance upsets both hospitals and drug makers.
Medicare names plans for Part D MTM demo
Can the FDA do more to encourage orphan drug development?
Generic companies press for REMS relief with Senate bill
FDA deluged with opinions on biosimilar naming plans.
The Centers for Medicare and Medicaid Service’s final ACO rule offers little for pharmacists.
CMS Medicaid plan ignores major drug-access issues.
FDA may step up enforcement for homeopathic products.
Pharmacist access to prescribing information may change.
Seeking proof of P&T committee members’ independence
Medicare oversight of hospital compounding is questioned.
As first biosimilar approval nears, key questions remain.
GAO eyes group purchasing organization hospital rebates.
Pharmacists are the focus of drug adherence pilot program.
Pharmacies wrestle with the FDA’s new drug-tracing rule.
The FDA’s plan for interstate compounding jars hospitals.
In a new 340B controversy, OPA rebuffs a court ruling
FDA starts light-touch inspections for some imports.
Hospitals gain a year to meet stage 2 meaningful use rules.
FDA draft guidance on 503B compounding widely faulted
The FDA has accepted its first biosimilar application.
Patients and small businesses might not be able to obtain some brand-name drugs when the new health exchanges are in place.
A new Medicare “G” code for transitional care may help to reduce the number of hospital readmissions.