Perspectives on Food, Drug, Medical Device & Cosmetic

Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

The White House issued an executive order on January 30, 2017 requiring agencies and executive departments to “identify at least two existing regulations to be repealed” whenever they propose or promulgate a new regulation.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

On December 9, 2016, the Senate Agriculture Committee filed report language for the National Bioengineered Food Disclosure Law, the legislation signed into law by President Obama in July to amend the Agricultural Marketing Act of 1946.

On December 7, 2016, FDA published a Notice in the Federal Register announcing that its Center for Food Safety and Applied Nutrition will begin publishing data extracted from adverse event reports the Agency has received for conventional foods, dietary supplements, and cosmetics.

USDA’s Food Safety Inspection Service (FSIS) recently announced that meat and poultry products may use the Nutrition Facts label recently finalized by FDA earlier this year.

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

A review of FSIS recall data from the past five years indicates that recalls of meat and poultry products due to the presence of foreign matter contamination have grown in number, particularly over the past year.

Earlier this week, the US Food and Drug Administration (FDA) issued revised food safety standards known as the “Manufactured Food Regulatory Program Standards” (MFRPS).

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.

The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.

As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.

Ending months of speculation, the Drug Enforcement Administration announced yesterday that it declined to down-classify marijuana from Schedule I of the Controlled Substances Act for the fifth straight time.

The Beer Institute (BI) announced last week that is was implementing a “Brewer’s Voluntary Disclosure Initiative” intended to encourage its membership to begin disclosing nutritional information about its products on product labeling, packaging and on product websites.

The House of Representatives has voted 306-117 to approve the bipartisan GMO disclosure bill to amend the Agricultural Marketing Act of 1946 and to establish a mandatory National Bioengineered Food Disclosure Standard.

Late Thursday night, the Senate voted 63-30 to approve a bipartisan GMO disclosure bill hammered out earlier by Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI). 

Manufacturers were reminded recently why resale price maintenance policies can be risky.

FDA announced Tuesday that it will begin reevaluating how it regulates the use of the term “healthy” on food labeling.

FDA recently issued its final guidance on restaurant menu labeling intended to help restaurants and similar retail food establishments understand nutrition labeling requirements under the Federal Food, Drug, and Cosmetic Act that may apply to them.

Last week, the Department of Health and Human Services (HHS) and Department of Agriculture (USDA) released the federal government’s 2015-2020 Dietary Guidelines.

The TPP will undoubtedly increase the volume of food choices within the twelve nation pact. Congress is well aware of this anticipated increase in competition and will work to ensure that US border agencies have the resources to enforce regulations to guard against unsafe and counterfeit products.

Recently, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion issued a Warning Letter to drug maker Duchesnay, Inc., after reality TV star Kim Kardashian endorsed the company’s morning sickness drug, Diclegis, on her Instagram account.