Lee Rosebush

Lee Rosebush

BakerHostetler

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9/29/2014 - Draft Guidance Drug Manufacturers FDA Manufacturers Medical Devices Online Platforms Popular Prescription Drugs Public Comment Social Media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

Special Edition: Health Law Update: Senate Passes "Drug Quality and Security Act"

On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration's (FDA) oversight of compounding pharmacies in light of last year's...more

11/20/2013 - Compliance DQSA Drug Compounding Drug Manufacturers FDA FFDCA Pharmaceutical Pharmacies Prescription Drugs

Regulation of Compounding Pharmacies Continues to Evolve with House Passage of "Drug Quality and Security Act"

In the current environment it seems that few, if any, pieces of legislation are moving through Capitol Hill. However, there is one area that has seen significant activity: the regulation of compounding pharmacies....more

10/9/2013 - Drug Compounding FDA Pharmacies

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

9/20/2013 - Drug Compounding FDA Pharmacies Prescription Drugs Product Recalls Subcontractors

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