Perspectives on Food, Drug, Medical Device & Cosmetic

The US Food and Drug Administration recently issued warning letters to four companies.

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

The US Department of Agriculture needs to strengthen its controls over the approval and oversight of agreements for the import of organic products into the US, according to a recent audit report issued by the Office of the Inspector General at USDA.

The food industry potentially faces a new challenge on disclosure at the local level with the recent passage of a San Francisco ordinance addressing antibiotic use.

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

While acknowledging some notable challenges, a recent USDA study concluded that most consumers seeking information on their food purchases would be able to access this information, given the proper education and tools to do so.

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative medicine. 

One of the primary reasons the United States lacks a national animal identification system is the fervent perception among farmers and ranchers that such a system would result in government control over their livestock and an invasion of privacy.

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3, 2017.

Continuing a trend that is certain to keep growing, three consumer groups recently filed a lawsuit against Sanderson Farms alleging false advertising for their poultry products labeled “100 percent natural.”

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency’s rules have been, in the agency’s view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.

In a widely anticipated move, the FDA announced this week that it will extend the July 2018 compliance date for the revision to the Nutrition Facts panel. The revised panel will display calories more prominently on the label, as well as list added sugars.

With organic foods now accounting for over $40 billion in total US food sales, and the accompanying larger scale of organic operations, increased scrutiny of the integrity of the National Organic Program represents a natural progression in the evolution of the program’s history.

This week, Sonny Perdue became the penultimate nominee for President Trump’s cabinet to be confirmed by the Senate.

National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests.

The Food and Drug Administration has just announced that it will hold a Public Meeting on March 9, 2017 to discuss use of the term “healthy” in the labeling of human food products.

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.