What’s the Delay, FDA?

As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection.  At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law or regulations. 

Technical Reference Document Issued for Quality Metrics

The FDA today released a technical reference document entitled, “Quality Metrics Technical Conformance Guide for the Implementation of the Draft FDA Guidance for Industry on Requests for Quality Metrics.”

This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported.  Remember that,

Compounding Guidance Finalized by FDA

With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action.  This also obviously assumes that the facility is operating in accordance with the appropriate controls by state or federal agencies.

 We Have Heard of Pay-for-Delay, Now We Hear about Pay for Pain

We have all read about the issue of pay-for-delay, where a generic company gets something in return for a patent settlement and agrees not to market a product for a period of time.  The Federal Trade Commission (FTC) is aggressively pursuing such cases as anticompetitive,but that is a topic for another day.  Now we may have a pay-for-pain proposition floating around Congress. 

Will There be a Plan B for Plan B?

Is there a reason to believe that the emergency contraceptive levonorgestrel (LNG), most popularly known as Plan B, may not be as effective in women that weigh more than 165 pounds or have a body mass index > 25kg/m2?  According to FDA in a Question and Answers document (here) posted on the Center for Drug Evaluation and Research (CDER) webpage yesterday,

Is FDA Starting to Think (Again) About Cloud Computing?

In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.

Can Prescription Prenatal Vitamins Be Medical Food?  FDA Says No!

The debate about whether prenatal vitamins are a medical food seems to have been clearly addressed once and for all in a revised Question and Answers Guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition” (here).  Among other issues addressed in the Q&A document, FDA clearly states its position that prenatal vitamins are not considered to be medical foods. 

FDA Seeking Comments on User Fees for OTC Review


In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process.

FDA notes that, while overall aspects of the drug, biologics and device review process are funded in part by user fees,

Up in Smoke

Well, not really-but on April 12, 2016 (my birthday), the FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER) gave a presentation (here) entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  It is quite interesting to note that FDA has been actively involved in the regulatory assessment of cannabinoid products for quite some time. 

Data Integrity Guidance Issues – Sounds Like a Softer FDA Song

While the number of data integrity (DI) findings have increased over the last few years, as evidenced by citations in a number of Warning Letters, the FDA stance on DI seems to have mellowed since the generic drug scandal of the late 1980s.  The FDA guidance document (here)   walks firms through their responsibilities in assuring that cGMP requirements relative to assurance of the accuracy,

Do the FDA Commissioner’s Remarks Spell Trouble for Generic Opioids?

In a recent speech given to the 2016 Opioid and Drug Abuse Summit, FDA Commissioner Dr. Robert Califf outlined the FDA’s plans on addressing the opioid abuse epidemic and touched on a number of important and critical issues that underscore the tough job ahead of them.  He emphasized that there needs to be a multipronged approach that reaches practitioners,