Live From BIO: FDA center directors discuss upcoming challenges

CHICAGO - FDA Commissioner Margaret Hamburg was joined by acting CBER Director Karen Midthun and CDER Deputy Director Douglas Throckmorton in addressing some of the challenges currently facing the agency.

During her presentation, Hamburg emphasized the need for a strong FDA that makes both the public and industry confident. She added that it is imperative for the agency to attract and retain the best scientists in order to bring fresh ideas. The agency also needs to continue to recognize that it is a global presence and will need to work with a number of countries, including those with less-regulated systems.

Midthun came next, discussing her center's efforts to enhance public health preparedness in the midst of such challenges as new laws and regulations like FDAAA, and the implementation of new standards including CDISC/SDTM. In addition, CBER is emphasizing transparency by issuing guidances, holding workshops to update stakeholders on such topics as emerging infectious diseases, and holding advisory committee meetings, including the one this Friday on GlaxoSmithKline's Rotarix. In March, the FDA recommended that healthcare practitioners temporarily suspend use of the rotavirus shot in the U.S. while the agency learns more about components of an extraneous virus detected in the vaccine.

At CDER, Throckmorton sees a number of challenges that will confront the center in the coming year. These include trying to implement the biosimilar approval pathway. The agency will have to resolve such issues as how to name the products and guidance development. PDUFA reauthorization also will be a challenge for the center, as will drug safety.

Suggested Articles

Bristol Myers Squibb is teaming up with Repare Therapeutics to find new synthetic lethality targets in a deal that could be worth billions.

Biotech Orpheris has been given the FDA go-ahead for a phase 2 aimed at calming the cytokine storm sometimes caused by COVID-19.

PureTech plans to start a trial in the emerging population of patients who survive COVID-19 only to suffer lasting damage in the third quarter.