Lee Rosebush

Lee Rosebush

BakerHostetler

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2/19/2015 - Draft Guidance Drug Compounding FDA Healthcare Facilities Pharmacies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

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more

11/24/2014 - HHS HRSA Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs Proposed Regulation Section 340B

Ebola and Emergency Access to FDA Unapproved Drugs in Life-Threatening Situations

As public health officials accelerate their efforts to develop a vaccine to combat Ebola—one that the U.S. Food and Drug Administration (FDA) has not yet approved for use—some may ask if there is ever an option for critically...more

11/3/2014 - Drugs Ebola FDA Healthcare Medical Emergencies

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more

10/17/2014 - Affordable Care Act Ambulance Providers Anti-Kickback Statute CMP Law Gainsharing Healthcare Medicaid Medicare Medicare Part D OIG Pharmacies Proposed Regulation Safe Harbors

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

9/29/2014 - Draft Guidance Drug Manufacturers FDA Manufacturers Medical Devices Online Platforms Popular Prescription Drugs Public Comment Social Media

Purple Is the New Orange

Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable biosimilars to be known as the Purple Book. The Purple Book is meant to be the...more

9/24/2014 - Biosimilars FDA Pharmaceutical Prescription Drugs Purple Book

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

9/22/2014 - Anti-Kickback Statute Co-payments False Claims Act Medicare Medicare Part D OIG Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of...more

9/22/2014 - Congressional Investigations & Hearings Draft Guidance FDA Laboratory Developed Tests

DEA Authorizes Take-Back Programs for Pharmacies

The U.S. Drug Enforcement Administration (DEA) recently issued a Final Rule expanding the facilities that can collect unused prescription drugs to now include retail pharmacies, hospitals and pharmaceutical manufacturers, as...more

9/15/2014 - DEA Pharmaceutical Pharmacies Prescription Drugs

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee...more

9/10/2014 - Anti-Kickback Statute Fees Healthcare HHS OIG Pharmacies

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

7/23/2014 - 340B FFDCA HHS Orphan Drugs PHRMA PHSA Prescription Drugs

FDA Releases Compounding Policy Documents

The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and...more

7/3/2014 - DQSA Drug Compounding Drug Manufacturers FDA FFDCA Manufacturers Prescription Drugs

The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA

On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and...more

6/24/2014 - Final Rules Healthcare HHS Orphan Drugs Pharmaceutical PHRMA Section 340B

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

5/29/2014 - DQSA Drug Compounding Enforcement FDA Pharmaceutical Pharmacies Prescription Drugs

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the...more

5/5/2014 - DQSA Drug Compounding FDA FFDCA Interstate Commerce Pharmacies

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