Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions (see here, here and here). On March 14, 2017, FDA made further progress on its Cures Act obligations by releasing in the Federal Register a proposed list of Class II devices that may be exempted from premarket notification (or 510(k)) requirements. The list is currently open for public comment until May 15, 2017. Under the Cures Act, the final list of exempted devices must be published by July 11, 2017.
Benjamin Zegarelli is an Associate in the firm’s Health Law Practice. He provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships. Benjamin has given numerous presentations on current health care industry topics and held the position of Executive Editor of the Cardozo Law Review.
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible. However, given the political climate in the federal government and the lack of an appointed FDA commissioner, it is unclear whether FDA will hold its ground or be forced to retreat.
On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what regulations apply. The final rule also excludes products derived from tobacco from regulation as “tobacco products” if such products are intended for use as a drug, device, or combination product. (We’ll be discussing the tobacco products portion of the rule in a separate post.) While this rule could have a profound effect on marketing schemes for tobacco products, drugs, and medical devices, Congress’s passage of the Midnight Rules Relief Act could eliminate the rule before it ever takes effect.
Over the past year, clear trends have emerged in FDA’s enforcement activities. Enforcement arising from alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) can take many forms, including FDA advisory actions such as warning letters, adverse inspectional observations that can lead to specific administrative actions like product recalls or import detentions, and the pursuit of product seizures using express judicial tools, criminal convictions, or civil settlements in cooperation with DOJ. Structurally, individual compliance offices within the FDA centers and regional offices can initiate enforcement activity against regulated industries, while the FDA Office of Criminal Investigations (OCI) has primary responsibility for criminal investigations conducted by the FDA and works closely with DOJ in setting enforcement priorities for new cases. Continue Reading Health Care Enforcement Review and 2017 Outlook: FDA’s Wide-Ranging Activities
As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements. This directive to apply RWE in the drug sphere is particularly interesting because FDA has issued a draft policy on the use of RWE in the context of medical devices, but has generally remained silent about applying RWE to pharmaceutical and biologic regulatory considerations. In this post, we briefly review the Cures Act’s RWE provision, as well as FDA’s recent public remarks about the use of RWE, and we provide some predictions on how FDA will implement the RWE evaluation program.
As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years resisted calls to loosen its long-standing prohibitions on the off-label promotion of unapproved products, it has simultaneously recognized that truthful and non-misleading scientific or medical information coming from manufacturers about their own drug, biologic, and device products plays an important role in the U.S. health care system. This has especially been true in a climate where individual products are becoming more complex; precision medicine approaches to treating disease are gaining ground in clinical practice; and the health system is evolving into one more focused on outcomes and value-based arrangements between entities. The expansion of First Amendment commercial speech principles by the courts over the past decade and lawsuits against FDA also have pushed the Agency to move towards the potential reform of its existing off-label policies. Continue Reading Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy
On November 7, 2016, FDA announced in the Federal Register its plan to research methods for including risk information about pharmaceutical and medical device products in promotional Internet communications that have character space limitations, such as sponsored links and microblogs. This appears to be the latest step in FDA’s plan to align drug promotion regulations with modern (or at least recently modern) communications technologies and platforms since releasing the draft guidance, Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (the “Social Media Guidance”) in June 2014.
On October 14, 2016, FDA released draft guidance entitled Software as a Medical Device (SaMD): Clinical Evaluation (the “SaMD Draft Guidance”). The draft guidance was prepared by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF), chaired by Bakul Patel, Associate Director for Digital Health at CDRH, and was endorsed by the IMDRF Management Committee in September 2016. Simultaneous with the release of the SaMD Draft Guidance, FDA announced the opening of a 60-day comment period to give the public a chance to react to the content of the draft guidance.
The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global centers of life sciences regulations, including the United States, the European Union (both the unified government and the individual countries), Brazil, Mexico, China, Japan, and other regions. Conference topics centered predominantly on international themes, such as the European Union Medical Device Regulation, China’s drug and medical device regulations, international implementation of the Medical Device Single Audit Program, and international implementation of social media promotion regulations.
FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft guidance, entitled Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”), is a revision to FDA’s 1997 final guidance of the same name (“1997 Final Guidance”). The other is a spinoff guidance, entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), which is specific to software modifications. It is important to note that the 1997 Final Guidance represents FDA’s official current policy on regulatory responsibilities stemming from device modifications, but in our experience, elements of the policy in the draft guidances may be used by the FDA immediately even before finalization. Continue Reading FDA Releases Revised Guidance on Device Modification Policy