On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices. The guidance describes when a Type V drug master file (DMF) can be used to
Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential
Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist human cell, tissue, and cellular and tissue product (HCT/P) manufacturers, as well as stakeholders that market HCT/Ps, to “obtain a rapid, preliminary, informal, non-binding assessment from
This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request process for oncologists. Under the new program, FDA staff will help guide physicians through the process of applying for expanded access by
At a press availability on May 10, Under Secretary of Defense for Acquisition and Sustainment, Ellen Lord, discussed the “matchmaking” service the Department of Defense (“DoD” or “Department”) is helping to create, to put small and struggling firms together with trusted sources of capital. This program may be viewed as a positive step that is
On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product. Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of
On May 10, 2019, FDA published a notice of availability for a final guidance document on Maximal Usage Trials (MUsT studies) for topically applied active ingredients being considered for OTC drug monographs, including sunscreens. As FDA has previously explained, the guidance states that MUsT studies can identify the potential for the systemic exposure for a
On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. The final guidance contains no significant substantive changes to the draft version, but here are a few interesting tidbits: FDA will respond to comments seeking clarification on
On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall, respond to an indication of a problem with a distributed product, and initiate a voluntary
On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market. Although the draft guidance doesn’t break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply. Citing
FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the greatest benefit to patients and providers, and (perhaps in particular) generic drug developers. The Commissioner’s announcement addresses several important issues, including patent listing standards
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some functions shut down, as was announced yesterday. Among other things, FDA has furloughed 42% of its employees, according
Earlier today, FDA published its finalized Data Integrity Guidance. The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency’s April 2016 Draft Guidance covering the design, operation, and monitoring of systems and controls to maintain data integrity to comply with current good manufacturing practice (cGMP) for
With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies.
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval inspections. The protocols were developed through the agency’s New Inspection Protocol Project (the “NIPP”), initially launched in 2014. The NIPP is intended to
On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law 115-92, which was enacted in 2017. The law gives the DoD new opportunities to advocate to FDA for expedited development,
On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims. In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell
President Trump today touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on an “International Pricing Index” (IPI), under which U.S. drug prices would be benchmarked against 16 other countries that reportedly have lower drug prices. This
On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would
Update (9/18/2018): Last week, as the U.S. House of Representatives was reconciling its spending bill for the Health and Human Services Department (HHS) with the amendment package passed by the U.S. Senate that is discussed below, House Republicans declined to adopt S.Amdt. 3964, which would have provided HHS with $1 million to issue rules requiring pharmaceutical companies to list prices
One day after the Venezuelan government held elections for a Constituent Assembly that the United States has asserted is aimed at rewriting the national constitution, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) designated the President of Venezuela, Nicolas Maduro.
Ahead of a Constituent Assembly that could re-write the Venezuelan Constitution and dissolve state institutions, the U.S. Treasury Department’s Office of Foreign Assets Control has designated 13 current and former Venezuelan government officials.
Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews, continue apace. This week saw the introduction of bipartisan legislation in the U.S. Senate that would (i) give federal agriculture and food officials permanent representation on CFIUS and (ii) amend the statute to allow the Committee to consider agriculture and food-related criteria when reviewing transactions that could result in control of a U.S. business by a foreign person.