Stick it to Me!

Today, the FDA announced the availability of a draft Guidance titled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications” (here).  The document discusses the way in which sponsors should document the adhesion of their proposed product with that the of reference listed drug (RLD).

 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,

FDA’s Most Recent Delay on the Generic Drug Labeling Rule Bodes Well for Industry (Hopefully)?

There are obviously two schools of thought on the Proposed Rule that would permit generic companies to unilaterally update their labeling to include new safety information.   On the consumer advocacy side, and from FDA’s view, it will improve patient safety (but personally I don’t see how).  But when you look at the Proposed Rule (as we have done here,  

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In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity.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.

LCS to Exhibit at the ISPE/FDA/PQRI Quality Manufacturing Conference

On June 6-8 at the Bethesda North Marriott Hotel, ISPE will be hosting the 4th annual Quality Manufacturing Conference, in collaboration with FDA and PQRI. Lachman Consultants is the sponsor of the Welcome Reception as well as the conference badges. In addition, we will be exhibiting in the hall at table 3. Please stop by our booth for a chance to win an iPad,

White Paper: Navigating Through the Clouds in Life

Whether we embrace it or not, the Data and Application economy is upon us. Every business is, in some respects, a digital business, and in the digital realm things change FAST.

The term ‘cloud’ as a technology concept has been in use since at least 1971, but even as recently as 2009 companies like IBM were just introducing it to prospective clients.

White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain a viable business. 

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. 

Let’s Not Mix Apples with Oranges

I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle.  But I think I’ve got it now, and I hope I am right! The way the “backlog” used to be counted pre-GDUFA was simply ANDAs that were pending at OGD.

What’s a Mother to Do?

We are not entirely sure how FDA makes its decisions to revise a BE Guidance document, but we are clearly in the dark as to how and when the FDA decision to require firms to repeat BE studies using the revised recommendation are made. I am sure that FDA will (as they have with certain products) tell a firm when it is absolutely necessary to repeat a study using a new BE recommendation, but FDA does not do this in all instances. What are the criteria for FDA’s decision making process?

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,

ANDA Receipts in April 2016


The Office of Generic Drugs (OGD) received 55 original ANDAs in April 2016, the third highest number of receipts in the 8 months of FY 2016.  The two higher months were December 2015 (180) and March 2016 (114).  OGD has received a total of 527 ANDA or an average of just a little over 75 (75.3) ANDAs/month so far this FY.