In a Federal Register Notice that published on February 27, 2014 (see here), the Drug Enforcement Agency (DEA) announced the proposed Rulemaking to place all hydrocodone-containing combination products into the more restrictive Schedule II category from Schedule III of the Controlled Substances Act. This process has been going on for several years and now looks like it will swiftly move towards becoming reality. This move has been hotly debated among consumer groups, healthcare providers, drug abuse experts and the like. FDA held a public advisory meeting in January 2013 to meet the requirement established by one of the provisions of Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). The Advisory Committee meeting was a compromise reached in FDASIA, as changing the schedule of these products was one thing that the Act’s sponsors had considered. The Committee that was charged with making a recommendation voted 19-10 in favor of the rescheduling effort.
With John Dingell’s Departure from Congress, Maybe it is Time to Reflect on the Generic Drugs Scandal
Some 4+ years after the most successful piece of legislation, the Drug Price Competition and Patent Term Restoration Act (more commonly known as the Hatch-Waxman Act), there was trouble in paradise. In late 1987, some firms noticed that certain applicants began receiving reviews and approvals of their ANDAs faster than they did. A simple investigation lead to evidence of wrongdoing by an FDA employee and lead to a widespread and expanded investigation into the industry, and uncovered wholesale fraud at a number of companies and exposed other FDA employees guilty of wrongful acts. This was the beginning of the Generic Drug scandal, which prompted the investigation of the entire industry by Congressman Dingell and two congressional investigators.
What Can Industry Do to Make their Applications of Better Quality? FDA Wants to Know! But, I Have a Different Question!
I received an email yesterday from FDA (as I am sure many of you have) soliciting suggestions on ways to improve the quality of generic applications. FDA has set up a docket to receive your input and also wants to know the best way to share the suggestions with industry….While I will give the FDA credit for the outreach, I also have to speak up for the industry as well. Over the years the requirements for ANDAs has done nothing but increase and increase, while at the same time FDA has been talking about ways to provide regulatory relief for post approval changes and risk- based review of ANDA and risk-based inspection of facilities.
Then FDA is looking for you! The implementation of the Generic Drug User Fee Act (GDUFA) has created about new 930 positions in the Center for Drug Evaluation and Research (CDER). With first year hiring over, there are still about 600 positions left to fill and FDA is aggressively recruiting.
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.
So You Think the FDA’s Proposed Label Change Rule Will Only Impact the Cost of the Printed Labeling – Think Again!
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.