The First Circuit Bankruptcy Appellate Panel recently issued a decision recognizing the rights of trademark licensees when the trademark’s owner files for bankruptcy.
In Mission Product Holdings, Inc. v. Tempnology...more
Puerto Rico’s financial woes have recently been front and center in financial news. Although a recent decision by the U.S. Supreme Court curtailed Puerto Rico’s ability to enact its own legislation to address its debt...more
This is the sixth in a series of alerts regarding the proposals made by the American Bankruptcy Institute Commission to Reform Chapter 11 Business Bankruptcies (the “Commission”). This alert covers the Commission’s...more
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
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 ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
FQHC ,
GPOs ,
Healthcare ,
HRSA ,
Managed Care Contracts ,
MCOs ,
Medicaid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B
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
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
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 ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medicare ,
Medicare Part D ,
Pending Legislation ,
Pharmacies ,
Prescription Drug Coverage ,
Prescription Drugs ,
Trade Associations
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
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
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
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
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
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
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
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
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
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
The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more
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
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
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
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
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
The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more