On January 12, 2016, the Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously approved the President’s nomination of Dr. Robert Califf as the next commissioner of food and drugs. (Senator Bernie...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
12/31/2015
/ Aetna ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CIGNA ,
CLIA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
OIG ,
PAMA ,
Stark Law
Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more
12/15/2015
/ Amarin ,
Biosimilars ,
BPCIA ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Off-Label Promotion ,
Personalized Medicine ,
Precision Medicine Initiative (PMI) ,
Preliminary Injunctions ,
Stem cells ,
Telemedicine
Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for...more
Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more
On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more
Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more
In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more
On November 12, 2015, FDA is scheduled to publish a notice in the Federal Register announcing a request for public comments on the use of the term “natural” in food labeling. As the Agency points out, it has been under...more
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more
11/5/2015
/ Anti-Competitive ,
Biologics ,
Biosimilars ,
EU ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
World Health Organization
On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more
10/17/2015
/ Biologics ,
Biosimilars ,
Comment Period ,
Generic Drugs ,
Governor Brown ,
New Legislation ,
Notice Requirements ,
Pharmacies ,
Pharmacist ,
Prescription Drugs ,
Proposed Regulation
On October 15, 2015, the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated...more
10/16/2015
/ Biotechnology ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
GMO ,
Obama Administration ,
OSTP ,
Public Meetings ,
Regulatory Standards ,
Request For Information ,
Transparency ,
USDA
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more
10/12/2015
/ Covered Entities ,
Databases ,
Distributors ,
DSCSA ,
Due Diligence ,
Food and Drug Administration (FDA) ,
Licenses ,
Pharmaceutical Distribution ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Third-Party Service Provider ,
Wholesale
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more
9/18/2015
/ Animal Food ,
CGMP ,
Farms ,
Federal Register ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Public Meetings ,
Recordkeeping Requirements ,
Risk Assessment ,
Risk-Based Approaches
On September 17, 2015, members of the Senate Health, Education, Labor & Pensions (HELP) Committee will have an opportunity to hear from and question Dr. Janet Woodock, the director of FDA’s Center for Drug Evaluation and...more
The International Campaign Against Microbeads in Cosmetics is most likely celebrating this week, following the California State Legislature’s passage of a bill that would prohibit the use of plastic microbeads in personal...more
A bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those...more
After months of pressure from industry, health practitioners and even congressional stakeholders, FDA has finally proposed a convention for assigning nonproprietary names (also known as proper names) to biological products....more
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more
This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more
As we’ve previously discussed, states have begun to actively regulate the substitution of interchangeable biosimilars before any FDA-approved biosimilar has even hit the market. State biosimilar legislation passed to date...more
As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more
7/29/2015
/ ATF ,
Consumer Product Safety Commission (CPSC) ,
Cosmetics ,
Dietary Supplements ,
Environmental Protection Agency (EPA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Illegal Drugs ,
Jurisdiction ,
Manufacturers ,
Medical Devices ,
NHTSA ,
Over The Counter Derivatives (OTC) ,
USDA
Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation.
In a statement released July 2, OSTP noted that...more
Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological...more
On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more