Let’s Clean This Up!

Today, FDA announced the issuance of a 137 page Proposed Rule designed to investigate whether antibacterial hand soaps are any more safe or effective than washing with simple bar soap. FDA is taking this action to evaluate the safety and effectiveness of these products due to the continued concern about the potential development of bacterial resistance from the widespread use of these agents. The Proposed Rule does not cover does not cover hand sanitizers, wipes or antibacterial products used in the healthcare setting. Rather, it is targeted towards the multitude of bar and liquid soaps used by consumers in routine daily hand and body washes that are advertised as, and contain an antimicrobial agent.

Getting Ready for October 1, 2014 – the Reality Check is Coming!

Having previously written about the need for Generic companies to step up the quality of their submissions to avoid refuse-to-receive (RTR) letters as well as avoiding time review penalties for major amendments or multiple minor or unsolicited amendments, I must take a moment to perform a reality check on what happens when the Generic Drug User Fee Act’s (GDUFA) metric kick in on applications submitted after October 1, 2014. As we know, there are no metrics for ANDAs submitted in years one and two of GDUFA; however, years three through five must be looked at with intense scrutiny in light of the good, the bad and the (potentially) ugly aspects of the metrics themselves.

The Issue of Functionality – And a New Draft Guidance Hits the Street

Ever since the implementation of the Generic Drug User Fee Act (GDUFA), Guidance documents are flying out of FDA and landing faster than the planes at Atlanta’s busy Hartsfield airport. One such Draft Guidance was posted yesterday on the FDA web site (here) entitled Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. While the specific issue addressed in this Guidance is clear, the general issue of something I like to call “functionality” is now being formally addressed through Guidance documents, as opposed to deficiency letters.

New Revised Bioequivalence Guidance Clarifies Requirements

FDA issued a newly revised Draft Guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Submitted Under an ANDA. The new Guidance document is specific to abbreviated new drug applications (ANDAs) and combines part of two previous guidance documents on general bioequivalence (BE) and BE for fed studies for ANDAs. The document does not address bioavailability (BA) or BE for investigational new drug applications (INDs) or for studies required to support BE for new drug applications (NDAs).

First Nuvaring Generic Equivalent Filed with a Paragraph IV Certification

Appearing on the FDA’s Paragraph IV database listing on December 3, 2013 is an ANDA filing for Ethinyl Estradiol and Etonogestrel drug-emitting polymeric ring that is used as a contraceptive to prevent pregnancy. What caught my eye and what it interesting about this product is that it is the first of a kind ANDA for an intravaginal contraceptive product of this nature. In addition, its posting date (December 3, 2013) and the ANDA submission date listed as June 17, 2013 (see chart below) suggests that either OGD has a very extensive backlog of ANDAs to process, or that this application presented some unique issues of either bioequivalence or chemistry manufacturing and controls that had to be resolved prior to a decision to receive (file) the application. My guess is that it might be the latter, since OGD has said it was expediting initial completeness and acceptability reviews of ANDAs with Paragraph IV certifications (indicating a challenge to the patent listed for the reference listed drug).

The Hardship of GDUFA Facility Fees

Since the implementation of the Generic Drug User Fee Act (GDUFA), many small facilities have complained about the establishment and facility fees being assessed under the Act. Unlike the Prescription Drug User Fee Act (PDUFA) where establishment (facility fees) are not due or paid until after the respective new drug application (NDA) is approved, GDUFA requires yearly payments of the facility fee while the abbreviated new drug application (ANDA) is pending. With median approval times at about 34 months, that may mean that 3 or more facility fees may be due prior to application approval. At the current rate of $220,152 for domestic facilities and $235,152 for foreign facilities, that could mean close to $700,000 in fees that a facility may have to pay prior to approval of an application that it is named in.

OGD Serious About Its Revised Communication Practices

While Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) and Dr. Kathleen Uhl, Acting Director, Office of Generic Drugs (OGD) are kicking around ideas about early communications of deficiencies and potential approvals to firms, the message that OGD is clamping down on phone calls and emails is being heard by Industry loud and clear.

Emergency! Emergency! Everyone to Get from Street

I am stealing a quintessential line from the movie “The Russians Are Coming, The Russians Are Coming”, to explain the emergent nature of the FDA’s proposed revision to its labeling rule to permit unilateral changes in safety information for certain applications for which the Federal Food Drug and Cosmetic Act (FDCA) clearly precludes such changes. So those of you in industry you have a choice – either raise your voices and raise them loudly, or contact your liability carriers and raise your limits and secure good defense counsel.