Prescription Drugs

News & Analysis as of

Learned Intermediary: Arizona Supreme Court Restores Order in the Desert

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases. The case is Watts v. Medicis Pharmaceutical Corp., No. cv-15-0065-PR, 2016 WL...more

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Health Care Outlook for 2016

In 2016, the Affordable Care Act will continue to be a contentious issue involving opposing legislative efforts and presidential debates. It has already been a major talking point in the campaigns of multiple 2016...more

Health Alert (Australia) - January 25, 2016

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments Commonwealth. Fair Work Commission 15 January 2016 - Lawrence v Calvary Home Care Services Ltd [2016] FWC 175 This...more

Also In The News - Health Headlines - January 2016 #3

CMS Finalizes Medicaid Prescription Drug Rule – On January 21, 2016, CMS finalized a rule detailing reforms to the rebate and reimbursement systems for Medicaid prescription drugs, which the agency estimates “will save...more

Drug Manufacturer Discount Cards: Accept With Caution

Pharmaceutical manufacturer discount card usage by government program beneficiaries has been an active area for government action in recent years. In a September 2014 Special Advisory Bulletin, the U.S. Department of Health...more

Increased Scrutiny of Drug Pricing What Should Pharmaceutical Companies Know

As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response. Early last year, the U.S. Department of Health and Human...more

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

Breaking News – Learned Intermediary Mandates Dismissal of 31 of 32 New Jersey Accutane Plaintiffs

The demise of the New Jersey Accutane litigation under the new mass tort judge continues apace. Today 31 more Accutane cases were dismissed for failure to establish warning causation under the learned intermediary rule. ...more

Medicaid Program: Covered Outpatient Drugs, Final Rule with Comment Period Summary

On January 21, 2016, the Centers for Medicare & Medicaid Services (CMS) released the final rule implementing the prescription drug rebate provisions enacted as part of the health care reform law, the Affordable Care Act...more

News from the Vermont Statehouse - An analysis from DRM's Government & Public Affairs Team - January 2016 #2

Paid Sick Leave Bill Appears on Track for Passage - The Senate Economic Development, Housing and General Affairs Committee on Thursday approved its version of a House-passed bill, H.187, that would require many Vermont...more

CMS Issues Final Rule on Covered Outpatient Drugs

On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more

The Challenge of Non-Interference

To understand the policy challenge created by repeal of the non-interference clause, consider this simple example. Acme Drug Company brings a drug to the market as a single source innovator. Essentially, they are without...more

Massachusetts Health Care Reform – Full Speed Ahead; Health Policy Commission 2015 Cost Trends Report

The Massachusetts Health Policy Commission (HPC) has issued its 2015 Cost Trends Report, based on the HPC’s annual health care cost growth hearings. The report contained 13 key recommendations across a wide range of health...more

FDA-regulated industries: Plan now for these changes in 2016

In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare...more

Manatt on Health Reform: Weekly Highlights - January 2016 #3

Louisiana's Governor pushes ahead on Medicaid expansion, while expansion is blocked by Wyoming's Legislature; Massachusetts plans to submit a 1332 waiver application to preserve its merged markets; and CBO lowers its 2016...more

MedPAC Votes to Recommend Changes to 340B Drug Payment Under Medicare Part B

For most of the past year, the Medicare Payment Advisory Commission (MedPAC) has been examining Medicare Part B payments to hospitals that participate in the 340B drug purchasing discount program in an effort to better align...more

Congressional Health Policy Hearings - January 2016

The Senate HELP Committee is holding a January 28, 2016 hearing on “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.” Separately, on February 4, the House Committee on Oversight and Government...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

Drug Costs, Risk Adjustment Drive Q2 Health Insurance Rate Increases

The Massachusetts Division of Insurance (DOI) recently held a two-day hearing on rate changes proposed by Massachusetts health insurance plans to be effective for the second quarter of 2016 (Q2). Presentations by carriers, in...more

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

CMS Releases Long-Awaited Final Medicaid Covered Outpatient Drug Rule

After months of speculation and waiting, CMS yesterday released its final rule to revise Medicaid reimbursement for covered outpatient drugs and reform Medicaid drug rebate requirements. While we are still digesting what the...more

Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary

We’ve been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that the learned intermediary doctrine (“LID”), which has been adopted in almost every state, was...more

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