Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created outsourcing facilities, have been on quite a rollercoaster ride since congressional enactment of the Drug Quality and Security Act (DQSA) approximately four-and-a-half years ago. Federal and State inspectional mandates have changed, FDA guidance documents (and a few regulations) have been churned out, and some entities have been the target of aggressive enforcement actions and even criminal prosecutions by the FDA/Department of Justice. Suffice it to say, this blog post cannot capture everything that compounders have been grappling with or how their compliance policies have been evolving. So today, we are sharing one important and positive bit of news for health systems and other entities that may be considering whether and how to set up an outsourcing facility under Section 503B of the Food, Drug, and Cosmetic Act (as amended by the DQSA). Continue Reading FDA Alters Course on Definition of Compounding “Facility” in Final Guidance
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.
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.
After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug competition issues, with the end goal of affecting drug prices, as well as current figures related to this year’s new drug and biologic approvals. A large proportion of those new products took advantage of the Breakthrough Therapy program and other expedited development/review pathways. Today we’ll begin where we left off and consider how the newest expedited review pathway, the RMAT Designation program, is doing one year after its creation by Congress. Continue Reading FDA 2017 Year in Review: Therapeutic Products, Part 2
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For those of us who monitor the Food and Drug Administration (FDA or the Agency) and counsel FDA-regulated entities, it has certainly been a whirlwind of a year.
2017 began with no clear picture of who would be assuming leadership of the Agency, but also with a brand-new piece of critically important (and bipartisan!) legislation – the 21st Century Cures Act (see our prior posts here) – which imposed new obligations and authorities on FDA that needed to be implemented, operationalized, and fully funded. In early May, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of FDA and he moved quickly to shift policy priorities in almost every area that the Agency regulates, a goal that in some ways was made more efficient due to the concurrent timing of modernization mandates imposed by the Cures Act. This year’s must-pass User Fee Act, the FDA Reauthorization Act or “FDARA” (see our prior posts here) engendered some hand-wringing and political drama over the summer, but was ultimately passed by Congress in August and signed into law. FDARA includes some important policy and programmatic changes for new prescription drugs/biologics, generic drugs, and biosimilars, but it did not contain major wholesale reforms to the Agency’s authorities due to the very recent passage of the Cures Act.
This is the first in a series of three installments that will review the actions FDA took in 2017, reflect on what they may mean for regulated industry, and provide a few predictions for 2018. This first installment, which will be broken up into two posts, focuses on therapeutic products; that is, drugs, biologics, human cells and tissue products, and gene therapies. Our subsequent posts will focus on medical devices and diagnostics, including whole-genome sequencing tests, and digital health and other software-related developments, respectively. Continue Reading FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership
On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.
The Hatch-Waxman Act (the Act), which Congress passed over 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has helped reduce patent-related barriers to generic drug entry, which, in turn, has increased competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Continue Reading Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market
Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level. In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.
This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback
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
It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.
Although the previous self-imposed congressional deadline of completing work on FDARA by the end of July has passed, FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any lay-off notices to user fee-funded staff “unless and until September 30 passes without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work. Continue Reading August 2017 Is Here – Will FDARA Get Done Soon?
Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post, the DSCSA requires enhanced security and accountability for prescription drugs throughout the U.S. pharmaceutical supply chain, with phased-in obligations for the various trading partners over 10 years, beginning with the law’s passage in November 2013. Covered trading partners include manufacturers, repackagers, wholesale distributors, and dispensers, whose upcoming compliance obligations under the DSCSA are all addressed by FDA in the recently issued Compliance Policy guidance document. Continue Reading FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements
It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased competition in the drug marketplace a high policy priority for the Agency. To that end, we have recently seen concrete steps being taken to advance Dr. Gottlieb’s multi-pronged “Drug Competition Action Plan.” Continue Reading FDA Stays in the Spotlight with Drug Pricing Moves, but Could Be Facing Risk as UFA Bill Loses Attention