Perspectives on Drugs & Biologics

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

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Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3,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

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.

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.

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on January 30, 2017 requiring agencies and executive departments to “identify at least two existing regulations to be repealed” whenever they propose or promulgate a new regulation.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

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. 

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

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.

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.

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs.

An Arent Fox team led by noted commercial litigator Hunter T. Carter prevailed at the US Court of Appeals for the Second Circuit.

The last decade has seen enormous growth in the human tissue products industry, following the Food and Drug Administration’s establishment, in 2001, of a tiered approach to the regulation of these products (referred to as “human cells, tissues and cell- and tissue-based products,” or “HCT/Ps”).

The Food and Drug Administration (FDA) has just issued its long-awaited Draft Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products.

The Food and Drug Administration (FDA) recently issued Guidance that describes circumstances that could occur during a drug facility inspection that might be deemed to constitute a “delay,” “denial,” “limitation,” or “refusal” of an inspection.

On September 30, 2014, the US Court of Appeals for the Ninth Circuit unanimously held that the first-in-the-nation Safe Drug Disposal Ordinance passed by Alameda County, California is constitutional.

On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States. The new Guidance is entitled “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act.”

On January 13, 2014, the FDA issued a Draft Guidance entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”