FDA

blog series tag - Navigating Life Sciences Transactions

This post is the fourth in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to market. CRAs, which govern the conduct of clinical trials, are essential for detailing which party will comply with the regulatory requirements while facilitating the commercialization of new drugs, devices, and digital health solutions.

On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Under the new rule, the FDA will phase out its laboratory developed test (LDT) enforcement discretion policy over a four-year period. The phaseout policy “applies to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA[1] and that meet the regulatory requirements under CLIA to perform high complexity testing, and used within such laboratories, even if those IVDs do not fall within FDA’s traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory.”

The Rise of Ketamine Clinics and Ketamine-Assisted Therapy

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the utilization of pharmaceutical drugs for, among other factors, unapproved indications. An approved indication occurs when the Food and Drug Administration (FDA) formally approves a given drug for a named medical condition.

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.

This year’s National Home Infusion Association (NHIA) conference kicked off with the 2nd Annual Sterile Compounding Forum. The well-attended track provided an overview of the state of sterile compounding, insight into the most common citations confronting sterile compounders, considerations for compliance and risks relating to compounding, background on how states and the FDA are implementing rules and regulations, including those involved in the delivery of home infusion products.

We are pleased to sponsor the NHIA conference and participate in the following activities:

On September 10, 2018, the federal Food & Drug Administration (”FDA”) released its revised draft standard Memorandum of Understanding (“MOU”) between states and the FDA addressing the interstate distribution of compounded drug products.  See 83 Fed. Reg. 175, 45631 et seq. (Sept. 10, 2018). The draft is the latest in the FDA’s decades-long effort to clarify state and federal roles in investigating and responding to complaints related to compounded drug products shipped between states.

The Orphan Drug Act aims to incentivize treatment of rare disorders or conditions affecting fewer than 200,000 persons in the United States through: (1) federal funding of grants and contracts to perform clinical trials of orphan products; (2) a tax credit of 50 percent of clinical testing costs; and (3) an exclusive right to market the orphan drug for approved orphan indications for 7 years from the date of marketing approval. While these financial incentives certainly make the business decision to engage in orphan drug development more palatable, the FDA does not approve orphan drugs on a separate pathway, despite the limited understanding of the diseases in question that presents developers of these drugs with problems stemming from small sample size and lack of well-defined efficacy endpoints.

The U.S. Food and Drug Administration (“FDA”) panel’s unanimous recommendation to approve Sandoz’ application for a filgrastim biosimilar of Amgen’s Neupogen® on Jan. 7, 2015, brings into sharp focus the provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) for resolving patent issues. The imminent approval by the FDA of Sandoz’ application now leaves resolution of patent issues for Sandoz to contend with as it prepares to launch its biosimilar filgrastim product. The lawsuit to resolve these issues, however, has just begun.

On April 16, in a win for Purdue Pharma, the maker of OxyContin, the FDA issued a decision approving updated labeling for Purdue’s reformulated, abuse-resistant OxyContin tablets. The decision places drug makers on notice that the FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the agency’s December 1995 approval of Purdue’s original OxyContin formulation.

The FDA’s decision was issued just as Purdue was set to lose its patent on the original formulation of OxyContin. Loss of this patent would have opened the opioid-painkiller market to competition from generic drug makers. But now, going forward, new applications for generic “copycat” forms of the drug must meet Purdue’s approved, abuse-resistant standard, without infringing upon Purdue’s patent for reformulated OxyContin, which lasts until 2025.

Concern over abuse of the well-known painkiller was central to the FDA’s decision. The agency explained, in a press release accompanying its decision: Purdue’s “labeling indicates that the [reformulated] product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).” The press release further stated that: The original formulation of OxyContin “was abused, often following manipulation intended to defeat its extended-release properties. Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death.”

According to the New York Times, the FDA’s decision was pushed by some state attorneys general, as well as pain treatment experts, who argued that the release of generic versions of OxyContin would feed street demand for the narcotic. Critics, however, have argued that the decision will result in higher prices for OxyContin, as the reformulated drug will not face generic competition.