At a Pharmaceutical Quality Assessment Workshop held in October 2005, Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER), spoke about CDER’s Vision: “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” CDER’s Vision was considered the desired state after the successful implementation by a manufacturing firm in accordance with FDA’s Initiatives: Pharmaceutical Quality for the 21st Century (initiated in 2004). In order to meet the Agency’s vision and ultimately, the desired state, FDA envisioned firms moving forward to establishing an effective pharmaceutical quality system, adopting a “Quality Culture”, proactively monitoring products and processes using risk-based approaches, ensuring a stable supply chain and investing in continuous improvement.
Alex Brill doesn’t think so either and in an economic analysis conducted for GPhA, he makes his point. The study outlines the following areas that FDA’s assessment apparently overlooked relative to downstream costs.
CDER published its yearly Guidance Agenda today giving the industry a look at what to expect for the coming year in terms of issuance of documents. This yearly exercise, while not guaranteeing that all of the guidance will actually be completed, provides a nice look into the important topics that CDER is planning to expound upon for the benefit of transparency.
After the issuance of MaPP 5200.3 back in September 2013 relative to communication with industry, voices rang out in pain aas the Generic industry felt as if its lifeline to information concerning the status of its applications were completely cut off. After a cacophony of complaints voiced by both GPhA and a number of firms in the Generic Industry, as well as at least one blogger, OGD has listened. Describing industry’s practices of constant contact with various OGD staff prior to and after GDUFA implementation, Dr. Uhl said “This practice was very resource intensive for us, and sometimes inadequately documented. It could also result in differential treatment of similarly situated applicants, giving rise to fairness and consistency issues.”
OGD recognizes that industry must have some information in order to run its business in an efficient and meaningful way and for making planning, manufacturing, and marketing decisions. In a recently issued (January 28, 2014) memo to the US Public Health Service (USPHS) Commissioned Corps Officers (CCO) assigned to OGD, the program will initiate a rather labor-intensive program to develop a complete inventory of all of each firm’s original applications (not supplements) to provide a one-time snapshot of all of where each firm’s applications are in the OGD review queue.
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) inserted a statement into Section 501(a)(2)(B)of the Food, Drug and Cosmetic Act that expanded the meaning of current good manufacturing practice (cGMP). FDASIA’s legislative history tells us that one intention was to require drug manufacturers to employ adequate controls over the materials they purchase. Most would agree that the hazards of unsafe materials justify the need for effective controls and oversight by manufacturers, and most companies are well aware of their responsibility to oversee safety and quality of materials used for manufacturing. FDA’s web page describing FDASIA promises that requirements of the enhanced 501(a)(2)(b)will be reflected in revised CGMP regulations. FDA’s 2014 Regulatory Agenda targets November for issuing a proposed rule. However, enforcement has already begun, and virtual companies are a target.
In a Federal Register Notice to publish on January 23, 2014, OGD is seeking comments and suggestions on how to improve the quality of submitted ANDAs and associated amendments to those applications. In addition, OGD is asking about what specific difficulties firms are having when preparing their ANDAs, so that FDA might help “provid[e] more or better information” to industry.
Three years has come and gone since FDA published its Federal Register Notice (here) requiring drug companies to reformulate their acetaminophen (APAP)-containing combination drug products to contain no more than 325mg of APAP per dosage unit. FDA gave manufacturers three years to make the change or face withdraw of approval of their applicants. In an announcement posted at the very end of the day yesterday, FDA gave final notice that “[I]n the near future we intend to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.”
With little activity seen in 2013 in the enforcement arena for marketed unapproved drug products, FDA will publish two Federal Register (FR) notices on January 10, 2014 addressing enforcement action for a number of products.
Well, just a few days ago I posted a blog on OGD activity for the first two months of FY 2014. Today, the December numbers came out and holy cow! While December is notoriously a month of heavy submissions due primarily to the end of year rush, this December beat all records at an astonishing 225 ANDAs.
Happy New Year to all and welcome back to the Lachman blog! The first reporting of the year addresses what is on every generic company’s mind – how is OGD doing since GDUFA’s implementation?
To all my readers – have a happy holiday season and a very happy, healthy and prosperous New Year.
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.
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.
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.
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).