David Horowitz

Firm/Organization: Hogan Lovells

Latest Articles

Will FDA be forced to implement a drug importation program?

By Meredith Manning & David Horowitz on July 23, 2019

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 importation of drugs that are (1) off-patent; (2) have no exclusivity remaining; (3) face no generic competition; and (4) can…

Focus on Regulation

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

By Mike Druckman & David Horowitz on June 24, 2019

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 the FDA regarding how specific HCT/Ps are regulated.” Under the program, FDA will respond within three business…

Focus on Regulation

FDA Chief of Staff: OTC reform remains “top priority” for FDA

By Heidi Gertner & David Horowitz on May 23, 2019

Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA. Based on these comments, FDA is clearly not giving up on monograph reform: FDA has long engaged in this effort, and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical…

Focus on Regulation

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for Continued Marketing

By David Horowitz & Heidi Gertner on May 14, 2019

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 topically-applied active ingredient. FDA believes that this information is necessary to determine whether additional safety studies are needed to support…

Focus on Regulation

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

By Jim Johnson, Jodi Scott, David Horowitz, Mike Heyl & Elizabeth Fawell on April 25, 2019

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 recall. Overall, FDA emphasizes the importance of pharmaceutical, biotechnology, medical device, food, tobacco, and animal products firms having made…

Focus on Regulation

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

By Heidi Gertner & David Horowitz on March 13, 2019

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 in light of changed conditions, including substantially increased sunscreen usage and exposure, and evolving information about the potential risks…

Focus on Regulation

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

By Randy Prebula, Philip Katz, David Horowitz, Janice Hogan & Jonathan Kahan on December 27, 2018

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 to a tweet from Commissioner Scott Gottlieb, M.D. Nonetheless, Dr. Gottlieb said the agency would be “continuing vital activities, to…

Focus on Regulation

FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

By David Horowitz, Jim Johnson & Lowell Zeta on November 15, 2018

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 develop standardized electronic inspection protocols to collect data in a structured manner; to reduce the variability in inspectional findings among…

Focus on Regulation

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

By David Horowitz & Mike Druckman on November 8, 2018

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, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S.…

Focus on Regulation

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

By David Horowitz, Susan Lee & Lowell Zeta on November 7, 2018

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 therapy” can treat serious diseases, including Parkinson’s disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, and heart attacks. Henderson…

David Horowitz

Will FDA be forced to implement a drug importation program?

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

FDA Chief of Staff: OTC reform remains “top priority” for FDA

FDA Doubles Down on MUsT Studies for Sunscreens and Issues Final Guidance on Absorption Studies that Will Likely Be Needed for Continued Marketing

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

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