Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 20 November 2013 | By Alexander Gaffney, RAC
US regulators announced Tuesday that they soon plan to hold a workshop on the treatment of metabolic diseases, a meeting originally scheduled to be held during the government shutdown.
Metabolic diseases and disorders refer to a broad spectrum of medical conditions which generally result in obesity and other health problems, such as heart disease and diabetes. As one of the fastest-growing health problems in the US and around the world, obesity has commanded prominent attention at FDA, and the agency has moved in recent years to approve new chemical and mechanical treatments like Vivus' Qsymia, Arena Pharmaceuticals' Belviq, Allergan's Lap Band System, and Ethicon's Realize Band System.
But as companies have sought to bring new therapies to market, they've also run into constant challenges along the way. Cognizant of safety issues brought to light by past drug failures (most notably Fen-Phen), FDA has been adamant about requiring extensive premarket data and rigorous postmarketing studies. Those requirements have put on hold at least one drug, Orexigen Therapeutics' Contrave (bupropion/naltrexone), which was seen as being especially curious since both components of the drug are independently approved by FDA for other indications.
Faced with criticism about its regulatory approval standards being too strict, FDA took to the pages of the New England Journal of Medicine (NEJM) in October 2013 to explain its thoughts.
"Because these drugs are associated with potentially serious risks and are intended to be taken long-term, it is important that their use be limited to patients for whom they are indicated," FDA reviewers wrote, adding that "there may be yet-unknown benefits and risks associated" with approved weight-loss products.
Concerns have also been raised about medical devices to treat obesity as well, and the devices are only indicated for those with a body mass index (BMI) of 40 or above who have failed all non-surgical options.
Since then, FDA has been mostly silent on the subject of obesity with the exception of planning a public meeting to be held in October 2013. There, FDA had planned to ask for public input on whether current US regulations are sufficient to promote innovation in medical devices intended to treat obesity.
Unfortunately for FDA, the meeting date coincided with the shutdown of the US government after legislators failed to reach an accord on the budget, and the meeting was postponed.
Now FDA has announced that the meeting has been rescheduled for 20 December, and said it plans to discuss the exact same topics.
As Focus noted at the time of the original posting, the meeting's agenda is somewhat unusual in that it is directly concerned with the costs of its regulations and the eventual reimbursement of medical devices by healthcare payers like Medicare. FDA previously discussed similar topics at a 2011 workshop on device development in obesity and metabolic disease (DDOMD) and a follow-up advisory committee meeting held in 2012 on general issues related to the design of clinical studies.
FDA said it wanted to take a closer look at the "changing regulatory and reimbursement paradigms for medical devices in the treatment of metabolic diseases" with the intent of finding out more about how such devices are developed and ultimately delivered to patients.
"The purpose of the public workshop is to facilitate discussion between FDA, the American Gastroenterological Association and other interested parties on the issues of device development, public and private payer reimbursement, venture capital, and regulatory pathways for device innovation and marketing," FDA explained in a Federal Register notice on 12 September 2013. "The workshop will provide a forum for discussing new approaches for the treatment of morbid obesity and other metabolic diseases as well as evolving approaches for the regulation and reimbursement of minimally invasive procedures."
If the notice is any indication, FDA may be trying to bridge the gaps between the evidentiary needs of payors and regulators so that clinical trials can be designed to better illustrate the value of a treatment to patients. That approach is already popular and growing among European health technology assessment bodies and regulators like the European Medicines Agency (EMA)
Five topics are set to be discussed at the meeting:
The workshop, entitled " Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation," will be held on 20 December 2013 in Washington, DC.
Federal Register Notice
Previous Focus Story