Regulatory Focus™ > News Articles > FDA Wants to Know: Do US Regulations Promote Innovation for Devices Intended to Treat Obesity?

FDA Wants to Know: Do US Regulations Promote Innovation for Devices Intended to Treat Obesity?

Posted 13 September 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is looking to tackle something of an unusual target at an upcoming meeting between the regulator, the American Gastroenterological Association (AGA) and the public: Reimbursement issues.


It's a relatively uncommon-though not unprecedented-issue for FDA to address given its mission to regulate the safety and efficacy of healthcare products, and not their eventual cost.

In recent years a number of entities, including the Regulatory Affairs Professionals Society (RAPS)-Focus' parent organization-have highlighted what they say is the convergence of regulatory and reimbursement issues as companies seek to minimize the delay between getting a product approved and obtaining payment from insurers or government payers.

As a result, since 2011 FDA has begun to take steps to bridge the gap between FDA approval and approval by the Centers for Medicare and Medicaid Services (CMS) under its national coverage determination (NCD) process. In 2011, FDA signed a memorandum of understanding with CMS to launch a Parallel Review pilot program intended to help the agencies work together more closely throughout the regulatory and reimbursement process.

"Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming," FDA explained in a statement at the time of the pilot program's launch. "Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations."

The Parallel Review pilot program looks to change this by allowing concurrent review, hypothetically allowing companies to reduce the gap between obtaining FDA approval and a reimbursement decision. Because Medicare is one of the largest purchasers, if not the largest, of medical device products in the US, a positive NCD can sometimes be a de facto approval for a product, as without the NCD a product might not have a market.

As of March 2013, the program has been used to cover transcatheter aortic valve replacement (TAVR) procedures (May 2012) and is currently evaluating Medtronic's Symlicity Renal Denervation system through a joint review process.

A Focus on Innovation

Now FDA says it wants to take a closer look at the "changing regulatory and reimbursement paradigms for medical devices in the treatment of metabolic diseases,"-a term notably including morbid obesity-with the intent of finding out more about how such devices are developed and ultimately delivered to patients.

The two-day workshop is also somewhat unusual in that it is focused as much on product innovation as it is on regulation. While FDA certainly takes the product development process into account when developing regulations and guidance, the topic rarely makes its way into meetings or workshops.

"The purpose of the public workshop is to facilitate discussion between FDA, the AGA 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."

That could stand to benefit a wide range of medical device manufacturers focused on weight-reducing products, such as Allergan (Lap Band) and Ethicon (Realize Band), assuming FDA comes away from the meeting with a changed perspective on the regulatory challenges faced by manufacturers, the needs to patients or the challenges of obtaining reimbursement.

FDA said it has five topics it is looking to discuss at the meeting:

  • Challenges to MedTech Innovation in the United States
  • Evolving Approaches for the Regulation of Minimally Invasive Procedures: The FDA Benefit/Risk Paradigm
  • Evolving Approaches for the Reimbursement of Minimally Invasive Procedures: How to Put a Price on Value
  • Obesity as a Disease: Redefining the Regulatory and Reimbursement Context
  • The "Process"-Investigational Device Exemption Review

Federal Register Notice

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