On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act (P.L. 111-148, Sec. 6002, amending Social Security Act Sec. 1128G), also known as the Physician Payments Sunshine Act (PPSA).  MiMedx executives claim that such reporting is unnecessary because the company’s products are tissues, which are not explicitly included in the regulatory definition of “covered drug, device, biological, or medical supply” to which the Open Payments Program apply (42 C.F.R. 403.902). As a result of falling outside this definition, MiMedx argues that it is not an “applicable manufacturer” required to disclose payments to physicians and teaching hospitals.  MiMedx’s product-specific reasoning aside, the company’s argument brings up an interesting point about the evolution of FDA-regulated products and the enforcement of the Open Payments Program requirements: Does the PPSA, and its corresponding regulations, require manufacturers of tissue-based therapies to disclose payment information? Continue Reading Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine.” Continue Reading FDA Commissioner Announces Stem Cell Enforcement Shift, Plans to Develop Comprehensive Regenerative Medicine Policies

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law.  The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our colleagues have previously discussed the Act’s many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act will allow FDA to grant accelerated approval to regenerative medicine products, while also providing the Agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is historic given increasing pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic. Continue Reading President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15. More than 150 people attended in-person, including our own Joanne Hawana, with another 500 webinar attendees. Continue Reading FDA Concludes Two-Day Public Hearing on Human Cell and Tissue Product (HCT/P) Regulatory Paradigm