By Jonathan Darrow This is Part III in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part III considers a path forward in the regulation of biologics. For Part I, click here. For Part II click here….
By Jonathan Darrow This is Part II in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already approved biological medicines. Part II covers some key considerations and factors that impact the biologics market and regulation. For Part I, click here. Reference…
By Jonathan Darrow This is Part I in a series exploring the history, challenges, and opportunities in the regulation of biosimilars, or biologic medical products that are very similar to already-approved biological medicines. This Part briefly covers the history of American regulation of biologics and touches briefly on the European experience. The Biologics Price Competition…
“Deep Dive” is broader than just pharmaceutical policy, and will explore market failures in health care, criminal justice, education, and public finance, including how to fix them.
Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources differently.
By Jonathan J. Darrow Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,”…
By Jonathan J. Darrow In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step…
Jonathan Darrow, PFC Student Fellow and HLS SJD student, will be presenting his chapter – “Pharmaceutical Efficacy: The Illusory Legal Standard” – on Tuesday, April 23, at noon in Hauser 105, Harvard Law School, Cambridge. If you’d like to review the chapter in advance, please be in touch with Jonathan directly: jon underscore darrow at…
By Jonathan J. Darrow Earlier this week the Supreme Court heard oral arguments in FTC v. Actavis, in which the Federal Trade Commission is asserting that it is impermissible for a brand name drug company to pay a generic drug company to stay out of the market. Normally, such collusive behavior would constitute a clear…
By Jonathan J. Darrow Earlier this week, the New York Times reported that Xolair (omalizumab), a monoclonal antibody approved in 2003 to treat allergic asthma, had recently shown efficacy in relieving hives patients of chronic itch (See Laurie Tarkan, Drug to Treat Asthma Could Relieve Hives Patients of a Chronic Itch, Study Says, N.Y. Times, Feb….
