Lee Rosebush

Lee Rosebush

BakerHostetler

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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 Codeine 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 Pharmaceutical Manufacturers 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 Pharmaceutical Manufacturers 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 Pharmaceutical Manufacturers

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The U.S. Food and Drug Administration (FDA) has released a Notice of Draft Guidance and Withdrawal of Compliance Policy Guidance (Guidance Notice), along with a Draft Guidance for Industry (Draft Guidance) addressing...more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

Amarin Pharma Sues FDA Over Constitutional Right to Discuss Off-Label Uses

Drug makers and the Food and Drug Administration (FDA) have often disagreed over whether drug makers can discuss unapproved uses for their products with physicians. While courts have sided with drug makers in certain...more

5/15/2015 - Corporate Counsel FDA Off-Label Promotion Off-Label Use Pharmaceutical Pharmaceutical Manufacturers

FDA Finalizes Guidance Documents on Biosimilars

Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance...more

5/15/2015 - Biosimilars BPCIA FDA Final Guidance Pharmaceutical Pharmaceutical Manufacturers

New Data on Part D Prescription Drugs Available

On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) made available a dataset that provides detailed information on medications that physicians and other healthcare providers prescribed under the Medicare...more

5/15/2015 - CMS Health Care Providers Healthcare Medicare Advantage Medicare Part D Prescription Drugs Section 340B

Compounding Pharmacies Protected by Medical Liability Act

In a court decision holding that a compounding pharmacy is entitled to certain protections against medical malpractice claims, the Supreme Court of Texas established a precedent that may well prove valuable to pharmacists...more

5/15/2015 - Drug Compounding Healthcare Malpractice Claims Pharmacies

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug...more

4/23/2015 - Generic Drugs Government Investigations Medicaid OIG Pharmaceutical Manufacturers Prescription Drugs

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

4/23/2015 - Biosimilars CMS FDA Health Care Providers Healthcare Medicaid Medicare Medicare Part B Medicare Part D Pharmaceutical Manufacturers Prescription Drug Coverage Prescription Drugs

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

The federal agency that oversees Medicare’s prescription drug program has alleged that a major U.S. insurance company misled beneficiaries about the pharmacies included in the company’s drug plan, and imposed a $1 million...more

4/21/2015 - Aetna CMS Health Insurance Medicare Medicare Part D Misrepresentation Prescription Drugs

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more

4/21/2015 - Healthcare HRSA OMB Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Rulemaking Process Section 340B

Bringing Predictability and Speed to DEA’s Scheduling of New Drugs

A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New...more

4/2/2015 - Controlled Substances Act DEA FDA Pending Legislation

FDA Establishes Docket for Public Comments on Drug Compounding

The Food and Drug Administration (FDA) recently announced a new docket for public comments on the compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA...more

3/17/2015 - Drug Compounding Drug Manufacturers FDA FDCA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Section 503

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate...more

3/10/2015 - Drug Compounding FDA FFDCA Healthcare Interstate Commerce Memorandum of Understanding New Guidance Pharmaceutical Pharmacies

FDA Guidance Documents Change Compounding Landscape

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance...more

3/9/2015 - DQSA Drug Compounding FDA FFDCA Healthcare New Guidance Outsourcing Outsourcing Facilities Pharmaceutical

Medicare Advantage and Medicare Part D Changes for 2016 Released

On February 6, 2015, the Centers for Medicare & Medicaid Services (CMS) released a final rule regarding changes to Medicare Advantage and Medicare Part D to take effect in 2016. According to CMS, this final rule “implements...more

3/6/2015 - CMS Final Rules Health Care Providers Medicare Medicare Advantage Medicare Part D

Now's the Time to Comment on the FDA's New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare...more

2/19/2015 - Draft Guidance Drug Compounding FDA Healthcare Facilities Pharmacies

FDA Proposes Electronic Distribution of Prescribing Information

Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more

1/28/2015 - Electronic Communications Electronically Stored Information FDA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Websites

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

1/27/2015 - FDA Marketing Orphan Drugs Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Product Exclusivity Summary Judgment

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

1/26/2015 - Affordable Care Act Biosimilars BPCI FDA Generic Drugs Novartis Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

New Guidance for 503B Outsourcing Facilities

Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug...more

12/2/2014 - Drug Compounding FDA FFDCA New Guidance Pharmacies Registration

Pharmacy Benefit Manager Faces Lawsuit by Compounding Pharmacies

In response to a decision to deny coverage of approximately 1,000 active ingredients that are widely used by compounding pharmacies to create topical treatments, three compounding pharmacies have filed a lawsuit against the...more

12/1/2014 - Drug Compounding Healthcare Pharmacies Prescription Drug Coverage Prescription Drugs

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