Lee Rosebush

Lee Rosebush


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FDA Publishes Guidance on Off-Label Use Communications

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more

3/1/2017 - FDA First Amendment Off-Label Use Pharmaceutical Industry Prescription Drugs

Human Drug Compounding: FDA Issues Four Guidance Documents

FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more

1/9/2017 - Drug Compounding FDA FFDCA New Guidance Outsourcing Outsourcing Facilities Pharmaceutical Industry

21st Century Cures: Ambitious Medical Innovation Bill Has Broad Focus

In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House...more

12/19/2016 - 21st Century Cures Initiative FDA FDA Approval Health Care Providers Mental Health Opioid

Coming Soon? Part D Covered Drug Moves to Part B

We may soon see a provision in the 2015 final rule addressing the utilization of end-stage renal disease related drugs and biologics come into action in the next few months. Specifically, the oral-only drug Sensipar may...more

8/15/2016 - Biopharmaceutical CMS FDA Medicare Part B Medicare Part D

Vermont to Require Drug Transparency

Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of...more

6/20/2016 - Attorney Generals Drug Pricing Manufacturers Medicaid Pharmaceutical Industry

HHS Reopens Comment Period for Proposed Rule on 340B Drug Program

The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...more

4/26/2016 - Civil Monetary Penalty Drug Pricing HHS Medicaid Pharmaceutical Industry Prescription Drugs Public Comment Section 340B

New Medicare Part B Payment Model is Most Recent Payor Response to Increasing Drug Prices

Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and pharmaceutical manufacturers engage in prescription drug arrangements. A recently...more

4/11/2016 - CMS HHS Medicare Medicare Part B Medicare Part D Pharmaceutical Industry Prescription Drug Coverage Prescription Drugs

CMS Pitches Controversial Payment Model for Medicare Part B Drugs

CMS recently announced a proposed rule that would potentially create a new Medicare Part B prescription drug payment model. The proposed model is intended to improve quality of care and deliver better value for Medicare Part...more

3/28/2016 - CMS Health Care Providers Medicare Part B Pharmacies Prescription Drugs

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

2/11/2016 - ANDA Antitrust Violations Biologics Clinical Laboratory Testing Corporate Counsel FDA Orphan Drugs Pharmaceutical Industry Pharmaceutical Patents Popular REMS Research and Development Young Lawyers

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

2/3/2016 - Audits Drug Pricing HHS OIG Pharmaceutical Industry Prescription Drugs

DOJ’s Increased Scrutiny of Pharmaceutical Manufacturer and Specialty Pharmacy Ties

Over the past two years, the relationship between pharmaceutical manufacturers and specialty pharmacies has been under increased scrutiny by the U.S. Department of Justice (DOJ). Specifically, the DOJ has targeted industry’s...more

11/10/2015 - DOJ False Claims Act (FCA) Kickbacks Pharmaceutical Industry Pharmacies

Hello Budget Agreement; Goodbye Provider-Based Status?

H.R. 1314, the Bipartisan Budget Act of 2015, was signed into law by President Obama on November 2, 2015. The two-year budget framework, which raises the federal debt limit through March 2017, partially rolls back the Budget...more

11/9/2015 - Affordable Care Act Bipartisan Budget Healthcare Physician Medicare Reimbursements Section 340B

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

10/26/2015 - Affordable Care Act Discounts FDA FFDCA Healthcare Healthcare Facilities HHS Interpretive Rule Orphan Drugs Pharmaceutical Industry PHRMA PHSA Prescription Drugs Public Health Service Act Section 340B

House Passes Bill to Help Prevent Prescription Drug Abuse

On September 8, 2015, the House of Representatives passed a bill intended to combat prescription drug abuse through the reauthorization of a program that provides federal grants to states for prescription drug monitoring...more

10/15/2015 - Data Collection Drug & Alcohol Abuse Federal Grants Healthcare Pending Legislation Pharmaceutical Industry Prescription Drugs U.S. House

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

9/28/2015 - DEA EPA FFDCA Hazardous Waste Health Care Providers Healthcare Illegal Drugs Pharmaceutical Industry RCRA Safe Drug Disposal

First Amendment Right to Off-Label Promotion – Has Pandora’s Box Been Opened for FDA?

A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more

9/17/2015 - Amarin FDA First Amendment FTC Healthcare Off-Label Promotion Off-Label Use Pharmaceutical Industry Prescription Drugs USDA

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

9/11/2015 - AIDS Audits Compliance Covered Entities Drug Pricing Fee-for-Service FQHC GPOs Healthcare HHS HRSA Managed Care Contracts MCOs Medicaid Pharmaceutical Industry Pharmacies Prescription Drugs Section 340B

How Far Is Too Far? Court Rules for Amarin in Off-Label Marketing Fight against FDA

Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more

8/20/2015 - Amarin DOJ FDA Healthcare Off-Label Promotion Pharmaceutical Industry Preliminary Injunctions Prescription Drugs Product Labels Warning Labels

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

7/28/2015 - American Academy of Pediatrics Black Box Warnings Children's Products Drug Safety FDA Healthcare Pain Management Prescription Drugs

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed...more

7/8/2015 - Covered Entities Drug Pricing Health Care Providers Hospitals HRSA Pharmaceutical Industry Prescription Drugs Section 340B

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

6/22/2015 - 21st Century Cures Initiative FDA Healthcare Medical Devices Medicare Medicare Part D Pending Legislation Pharmacies Prescription Drug Coverage Prescription Drugs Trade Associations

Otsuka Suit Results in Victory for FDA

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

6/5/2015 - FDA FDCA Generic Drugs Otsuka Pharmaceutical Pharmaceutical Industry Product Exclusivity

FDA Committee to Continue Considering Drug Compounding Issues

The advisory committee tasked with providing advice on medical, scientific and technical issues to the Food and Drug Administration (FDA) on compounded drugs is slated to continue its examination of matters concerning access...more

6/3/2015 - Advisory Committee DQSA Drug Compounding FDA FFDCA Healthcare Pharmaceutical Industry

FDA Addresses Compounding of Animal Drugs From Bulk Drug Substances

The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more

5/22/2015 - Animal Drugs Draft Guidance Drug Compounding FDA FFDCA

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