September 12, 2016

CANTON, Mass., Sept. 12, 2016 /PRNewswire/ — Organogenesis Inc., a global leader in FDA-approved and FDA-cleared advanced wound care innovation and technologies, today urged the U.S. Food and Drug Administration (FDA) to finalize two draft guidance documents that would clarify the existing regulatory criteria for determining if products qualify for regulation solely as Section 361 Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) – and in doing so, bring needed regulatory oversight to the wound care industry.

Speaking at an FDA public stakeholder meeting, Organogenesis’ Senior Vice President of Regulatory and Government Affairs,Patrick Bilbo, applauded the agency for its efforts to provide clarity around this class of products, and said the finalized guidance is critical to ensure that products currently marketed for healing of chronic wounds undergo the appropriate level of FDA review.

“Leg and foot ulcers that fail to heal are an immense public health challenge, typically affecting the elderly and people with diabetes – and if not effectively treated these ulcers can lead to osteomyelitis, amputation and death. The availability of safe and effective treatments is therefore a critical public health concern,” said the Organogenesis representative. “We believe that patients suffering from chronic wounds should receive therapeutic treatments that have met FDA’s rigorous pre-approval evidentiary standards.  Many health care providers, however, are unaware of the regulatory differences and standards.  Without guidance that provides clarity for the industry, confusion over which products have met these strict standards will persist.”

Under Section 361 of the Public Health Service Act, Congress permits donated human tissue to go directly to market without any FDA pre-market review for safety and efficacy.  In implementing regulations for Section 361, FDA set forth specific criteria for the type of tissue that would qualify for regulation only as a Section 361 HCT/P.  Products that meet these criteria are subject only to controls that are intended to prevent the transmission of infectious disease.

“It is clear that Congress never intended that Section 361 would be used by commercial entities to circumvent the FDA regulatory review process to market manufactured allografts as medical therapies to treat, prevent, or mitigate a disease,” said Bilbo.

The FDA meeting, originally scheduled for April 2016, was rescheduled to Sept. 12-13, 2016, to accommodate the number of concerned stakeholders. Other speakers who testified in support of finalizing the Section 361 HCT/P draft guidance included representatives from the clinical, research and development, and patient advocacy communities, who expressed concerns about the current lack of clarity and its impact on patient safety.  Several presenters cited confusion regarding the labeling and clinical efficacy of products that are marketed for wound healing despite never having undergone pre-market review or a rigorous clinical trial process.

The availability of safe and effective treatments for chronic wounds is a critical public health concern.  Leg and foot ulcers – some of the most common chronic wounds – are a serious public health challenge, with venous leg ulcers alone estimated to affect approximately 2.5 million people in the U.S.¹  Often leading to osteomyelitis and amputation, they are a major cause of disability in the elderly and in people with diabetes, and the annual cost to the healthcare system runs to billions of dollars.  The growing prevalence of diabetes and vascular disease – now the leading cause of limb loss in the U.S., according to the Amputee Coalition – makes the need to protect patients and provide accurate product classifications and marketing descriptions to clinicians all the more important.

Unlike the rigorous FDA premarket review paradigm for wound healing products like Organogenesis’ FDA-approved Apligraf® and Dermagraft®, which have undergone large-scale prospective, randomized clinical trials demonstrating their safety and efficacy, Section 361 HCT/Ps have no pre-market review requirements and are subject only to controls that intend to minimize infectious disease risk. A number of allograft manufacturers have seized on this minimally-regulated pathway to market, self-designating their products as Section 361 HCT/Ps when they likely do not qualify as such.

“Many companies are self-designating their products as Section 361 HCT/Ps even though the products do not in fact meet the criteria set forth in section 1271.10.  These companies have introduced to the market a host of human tissue products claiming to interact with the body in complex ways.  These products are processed in ways that are not minimal, are promoted for uses that fall far outside the realm of homologous use, and claim comparative or superior efficacy to FDA-approved biologics and devices.  This situation puts some of our most vulnerable patients at risk and must not continue,” said the Organogenesis representative.

“The draft guidances are a welcome step toward imposing order on an industry that has been operating more or less free from meaningful oversight.  It is critical for the public health as well as the future of the regenerative medicine industry that FDA finalize the draft guidance documents with all possible speed,” concluded Bilbo.

The full text of the remarks can be found here.

About Organogenesis

Massachusetts-based Organogenesis Inc. is a global leader in advanced wound care innovation and technologies, including bio-active wound healing and soft tissue regeneration. Organogenesis’ product portfolio includes FDA-approved Apligraf® and Dermagraft®, the best-in-class products for bio-active wound healing, and the recently launched, FDA-cleared PuraPly Antimicrobial™, which manages bioburden and supports healing for a wide variety of wound types.

¹ Brem H et al, Protocol for the successful treatment of venous ulcers. Am J Surg. 2004 Jul;188(1A Suppl):1-8.

Media Contact:
Erin Schmidt, (703) 548-0019
eschmidt@schmidtpa.com

Photo – http://photos.prnewswire.com/prnh/20160912/406508

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com

By MELINDA BECK – August 29, 2016

In two days of hearings next month, the U.S. Food and Drug Administration will consider if clinics offering stem-cell treatments should be more closely regulated.

Stem-cell treatments aren’t approved by the FDA and not long ago, Americans had to travel to Mexico, China or elsewhere to receive them. Now, with the regulatory environment murky, clinics offering them are spreading rapidly across the U.S. A recent report in the journal Cell Stem Cell counted 570 clinics advertising stem-cell therapies directly to consumers. Many claim to treat a long list of disorders, from arthritis to Alzheimer’s disease, even though the stem-cell treatment for many of the conditions hasn’t yet been tested on humans. Treatment typically costs thousands of dollars.

Critics, including many top stem-cell scientists, say the clinics are peddling 21st century snake oil and want the FDA to crack down. Clinic operators say they don’t need FDA approval because they are practicing medicine, not creating new drugs. Some patients say they have been helped and that the government shouldn’t regulate what they do with their own cells.

Stem cells, found in both embryos and adult tissues, offer enormous promise to scientists because they have the potential to develop into many different kinds of cells or serve as the body’s own repair service. Research is exploding into ways stem cells might be harnessed to cure diseases, mend damaged tissue, even grow replacement organs.

But most such research is still in the early stages. To date, the FDA has approved only a handful of stem-cell treatments, mainly for blood diseases such as leukemia. Scientists say much more work needs to be done to understand how stem cells work and what uses are safe and effective.

“We need to make sure that these technologies are reliable and reproducible, time and time again, before you put them into patients,” says Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, N.C., which has 450 researchers working to create new tissues from stem cells.

READ THE REST HERE

September 12, 2016 By BRAD PERRIELLO

A federal appeals court today overturned the enhanced damages and attorney fees awarded in Stryker‘s (NYSE:SYK) $70 million patent infringement win over Zimmer Biomet (NYSE:ZBH), but upheld its prior ruling that patents were valid and infringed.

The case was sent back to the U.S. Court of Appeals for the Federal Circuit in June, when the Supreme Court held that the standard for enhanced damages awards in patent infringement cases should be relaxed. The case dates back to December 2010, when Stryker sued orthopedics rival Zimmer, alleging infringement of 3 patents covering wound debridement technology by Zimmer’s Pulsavac Plus device.

In February 2013 a jury in the U.S. District Court for Western Michigan awarded $70 million to Stryker in damages plus royalties, ruling that Zimmer infringed all 3 patents claimed in the suit. Judge Robert Jonker trebled the damages in August of that year, ruling that the infringement was willful, ordering a permanent injunction and granting Stryker’s bid for lost profit damages for another nearly $2.4 million. The judge also granted Stryker’s motion for prejudgment interest, awarding nearly $11.2 million, plus reasonable attorney’s fees and additional prejudgment interest on those fees at a rate of 3.83%.

READ THE REST HERE

By Michael Mezher – September 7, 2016

The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices.

In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products.

Under the UDI rule, FDA established a phased, risk-based approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015. Class II devices, other than those listed in Tuesday’s letter, will need to comply later this month.

Since issuing the final rule in 2013, FDA has pushed back UDI compliance dates for certain products, such as Class III contact lenses and number of different orthopedic implants. Last week, FDA announced it would delay enforcement of another UDI provision that would require device makers to remove National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers from their devices by 24 September 2018 by three years.

Class II UDI Compliance

Now, FDA says it is extending the compliance date for certain Class II devices from 24 September 2016 to 24 September 2018, giving manufacturers two more years to meet UDI requirements for the affected products.

READ THE REST HERE

LITTLE SILVER, N.J., Sept. 8, 2016 /PRNewswire/ — Additive Orthopaedics, LLC., an early stage orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed osteotomy wedge system, to address bone fractures or osteotomies in the foot and ankle. This is the Company’s second innovative device leveraging additive manufacturing that has been cleared through the FDA.

September 06, 2016

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News