PharmaMedDevice Industry Blog

Calling all Regulatory Affairs Professionals!

As you know, the role of today’s regulatory affairs professional is changing as the life science industries continue to converge.  It is becoming increasingly more difficult to remain solely a “medical device” or “pharma” person as combination products continue to become more mainstream.  Individuals who can apply their multi-modality expertise across the life science industries are a real asset to the combination products market. According to RAPS research, the number of regulatory professionals involved in combination products has increased from an estimated 12% in 1999 to nearly 30% in 2006.

Changing of the guard at the OCP

The US Food and Drug Administration (FDA) has named Joanne Less as the acting director of the Office of Combination Products (OCP). Less recently replaced Mark Kramer, who recently resigned as FDA's director of the OCP. Less is currently the associate director for clinical research and government affairs in the Center for Devices and Radiological Health and is considered the expert on the laws, regulations, and policies governing the clinical investigation of medical devices. Less recently made her debut at PharmaMedDevice's Conference and Exhibition regarding the FDA's Premarket Review Process for Combination Products, where she gave great insight on strategic steps for bringing combination products through the FDA review process.

In step with this change, GE Healthcare has announced that Mark Kramer has joined as Vice President, Regulatory Affairs. Kramer brings a wealth of knowledge to this postion at GE with more than 17 years of experience from the FDA as well as insight on regulatory affairs and quality compliance relating to their product development. Read more at http://www.dotmed.com/news/story/3735/.

Congratulations to both and we are excited to see how this will positively impact the converging industries of pharma, medical device, and biologics.

Do your combination product homework

by Christopher Delporte, Group Editor, Medical Product Outsourcing

No matter how promising the therapy an innovative drug-device combo offers, regulatory waters still must be navigated and the nature of the category presents unique challenges. The FDA’s Office of Combination Products (OCP) was created in 2002 to facilitate the review process by helping to determine which agency branch would best evaluate a product.

The OCP evaluates the product’s primary mode of action and assigns review to the center within the FDA with primary jurisdiction over that component. Because manufacturers bringing a new product to market often face

Drug-Eluting Heart Stent Update

There's no question that there has been a flurry of media coverage related to drug-eluting stents (DES) over the past six months. In the fall of 2006, the FDA issued an initial statement related to concerns about new data that suggested a small, but significant increased risk of stent thrombosis (clotting) in patients who have been treated with cardiovascular DES. While the new data raised important questions, the Agency did not have enough information to draw any substantial conclusions. In early December of 2006, the FDA’s Circulatory Systems Devices Advisory Panel met with goals of providing a forum for the presentation of related clinical data and addressing the appropriate duration of medicinal therapy in DES patients (aspirin plus clopidogrel).  Panel members and speakers included interventional and non-interventional cardiologists, cardiovascular surgeons and the manufacturers of the two approved DES products, Boston Scientific and Cordis. (Photo: TAXUS® Express²™ Paclitaxel-Eluting Coronary Stent System, Source: Boston Scientific)

The Panel had the following recommendations regarding DES when they are used in accordance with their approved indications:

Combination Products: from regulatory concerns to success stories

by Sean Fenske, Editor-in-Chief, Medical Design Technology
As we experience the emergence of what will become an overwhelming trend in healthcare with the combination of drugs, devices, and biologics, education and information at this early stage is of significant importance. Events such as PharmaMedDevice will serve as a platform from which the next generation of combination healthcare products will emerge. Companies will look to other sources as well for guidance and expert advice on new innovations and unique technologies that are well suited for this area. Recently, Medical Deisng Technoogy Magazine produced the “Combination Products” supplement in order to serve this purpose, with articles raising many interesting perspectives and updates on current research and product development -- ranging from regulatory concerns to success stories ...

FDA Nanotechnology Task Force Formation

On November 2, 2006 acting FDA Commissioner Andrew C. von Eschenbach MD announced the formation of an internal FDA Nanotechnology Task Force. This new task force is charged with determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotech materials. The task force will identify and recommend ways to address any knowledge or policy gaps that exist, so as to better enable FDA to evaluate possible adverse health effects from FDA-regulated products that use nanotech materials.