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Joanne Hawana is Of Counsel in the firm and is based in our Washington, DC office. Her practice focuses on advising US and international clients in the food, drug, medical device and biotechnology industries on the business impacts of new US federal and state actions affecting regulated products. Joanne has in-depth knowledge of US federal drug regulations, including pre-market and post-market requirements as well as restrictions on advertising and sampling. She regularly works with clients to draft and submit public comments to agency rulemaking dockets, and frequently analyzes and summarizes new legislation and regulations with client interests in mind.

In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series of blog posts that aim to educate and inform our readers about why the UFA acronym matters and how the UFA legislative process may be particularly significant in 2017.

UFA stands for “User Fee Act,” of which there are many flavors in this modern era – from the old-timer Prescription Drug User Fee Act (PDUFA), born in 1992, to the more toddler-ish Biosimilar User Fee Act (BsUFA) that joined us in 2012. Other important UFAs for the U.S. health care system and stakeholders are the Medical Device User Fee Amendments (MDUFA), which were enacted first in 2002, and the Generic Drug User Fee Amendments (GDUFA) that launched at the same time as their biosimilar companion. Continue Reading Let the 2017 “UFA” Games Begin!

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration (see here and here). However, since taking office, President Trump has followed through on his campaign promise to significantly roll back Federal regulations and has taken several actions aimed at slowing and reversing agency regulatory processes, including processes at the DHHS sub-agencies CMS and FDA. These executive actions are creating a climate of uncertainty for regulated industries and their stakeholders. Continue Reading Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.

First, since being signed into law by former President Obama on December 13th, we’ve been writing and speaking about the myriad provisions of the 21st Century Cures Act. This wide-ranging law has many mandates for agency actions and new guidance documents, which FDA will be working on beginning this year, but far beyond 2017 as well. Drug, biologic, and medical device stakeholders are also awaiting the outcome of the upcoming reauthorization of all the major User Fee Acts that are “must-pass” legislation before the end of the current fiscal year (FY17 ends on September 30th), in order to ensure FDA’s continuing operations. Many other policy changes that are expected to result from the switch from a Democratic-led to a Republican-led Executive Branch, the latter also being supported by a GOP-controlled Congress, will likely have major impacts on medical product developers.  Continue Reading FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”

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

Since congressional enactment and presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions (see here and here).  One small, but by no means insignificant, change is the Cures Act’s explicit recognition that drug and biologic manufacturers should have the ability to promote their products to payors and health plans through well-developed “health care economic information.” Continue Reading Cures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors

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

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

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA).  The meeting will take place on October 14, 2016 at the Agency’s campus in White Oak, Maryland.  This webpage provides further information for potential attendees.  The upcoming event will be the first public meeting convened by FDA to address DSCSA-related issues.  The DSCSA requires the Agency to conduct at least 5 such meetings during the lengthy implementation period in order to keep it engaged and communicating with relevant stakeholders.

As we have described previously (see here and here), the goal of the DSCSA is to implement enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain.  It created phased-in obligations for various “trading partners,” such as manufacturers, distributors, and dispensers, over a 10-year period, beginning with the law’s passage at the end of 2013.

Among many others, one of the impending obligations facing industry is the requirement that manufacturers and repackagers affix or imprint a product identifier, at the package level, to prescription drug products that they introduce into commerce.  This product identification step is also referred to as “serialization,” and eventually trading partners will only be allowed to sell and buy serialized drug products.  Manufacturers and repackagers must comply with their initial product serialization mandates by November 2017 and November 2018, respectively. Continue Reading FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Open Pill BottleTimes, They Are A-Changin’

On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, health care organizations, and payors and insurers, regarding the appropriate regulation of manufacturers’ communications about off-label uses for their marketed medical products. Medical products include prescription drugs, biologics, medical devices, and animal drugs. This public meeting was originally “teased” by Agency officials as far back as April 2015, so it has been highly anticipated by all interested stakeholders. FDA’s announcement also comes after a series of high-profile losses for the Agency and the DOJ in the government’s attempt to prohibit and criminalize truthful, non-misleading off-label marketing. Continue Reading FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

As we predicted in yesterday’s post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its Arthritis Advisory Committee voted unanimously in support of approving the biosimilar. FDA followed its draft naming guidance and assigned the biosimilar’s non-proprietary name using the reference product’s drug substance name followed by a nonsense four-letter suffix. Erelzi becomes the third biosimilar to receive FDA approval (the second for Novartis subsidiary Sandoz) and is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, similar to Enbrel.  However, Erelzi cannot be launched commercially until at least 6 months after Sandoz provides Amgen with the mandatory notice required under the law, which the Federal Circuit Court of Appeals has affirmed cannot be provided until after FDA approves the biosimilar application.