Seminar with Michael S. Sinha

Costly Gadgets: Barriers to Market Entry and Price Competition for Generic Drug-Device Combinations in the United States

AbstractPhoto of M. S. Sinha

Prescription drug prices continue to rise unabated in the United States, largely due to a system that allows brand-name drug makers to charge whatever the market will bear. Some of the costliest pharmaceuticals in the United States—both by price and by total expenditure—are drugs that require a drug delivery device for proper use. Examples include respiratory inhalers, immunologic drugs, opioid overdose reversal drugs, patches for chronic pain, emergent anaphylaxis treatments, and insulin products. One of the ways manufacturers have successfully extended market exclusivity on such combination products is by pursuing “tertiary patents” on the device component of the product.

Once all patents have expired on a drug-device combination, generic entry has been made complicated by the FDA’s strict standards for approving “complex generic” products via the Abbreviated New Drug Application (ANDA) pathway. These additional requirements have proven particularly onerous for some generic firms, and given such obstacles to complex generic approval via the ANDA pathway, many companies have turned to an arguably more straightforward path to compete with drug-device combinations that have expired patents: the 505(b)(2) new drug approval (NDA) pathway.

This presentation takes the following format: (1) a detailed explanation of the various challenges to generic competition in combination products; (2) a description of the FDA’s complex generic ANDA approval process and experience to date; (3) three empirical case studies that provide real-world perspective to these market inefficiencies; and (4) proposed solutions for Congress, the FDA, and other key stakeholders as they attempt to address the high cost of pharmaceutical-device combinations in the United States.


14 January 2022, 17:00-18:00 CET


Zoom, link provided upon registration


Please register no later than the 13 January 2022 at 10:00 (CET) using this registration form


Dr. Sinha is a Research Collaborator at the Harvard-MIT Center for Regulatory Science, within the Harvard Program in Therapeutic Science (HiTS) at Harvard Medical School. He is also affiliated with the Program On Regulation, Therapeutics, And Law (PORTAL), within the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine at Brigham and Women’s Hospital and the Center for Health Policy and Law at Northeastern University School of Law. Medical publications have appeared in NEJM, JAMAJAMA Internal MedicineMayo Clinic Proceedings, CHESTPLOS MedicineHealth Affairs, the American Journal of Public Health, and the American Journal of Bioethics. His legal scholarship includes articles in the Journal of Legal Medicine, the American Journal of Law & Medicine, the American Journal of Law and Medicine, the Journal of Law, Medicine & Ethics, the Harvard Law & Policy Review, the Food and Drug Law Journal, the Stanford Law & Policy Review, the Journal of Law and the Biosciences, the Hastings Law Journal, and the Minnesota Journal of Law, Science & Technology (forthcoming).

Find out more about Michael S. Sinha