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
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
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
/ Abbreviated New Drug Application (ANDA) ,
Antitrust Violations ,
Biologics ,
Clinical Laboratory Testing ,
Corporate Counsel ,
Food and Drug Administration (FDA) ,
Orphan Drugs ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
REMS ,
Research and Development ,
Young Lawyers
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
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
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 ,
Department of Health and Human Services (HHS) ,
Discounts ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Interpretive Rule ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
PHSA ,
Prescription Drugs ,
Public Health Service Act ,
Section 340B
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
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
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
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
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
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
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
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
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
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
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 ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drug Coverage ,
Prescription Drugs
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
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
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
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