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# Woodcock: ‘Business as Usual’ as New Administration Looms
- URL: https://www.fdaweb.com/woodcock-business-as-usual-as-new-administration-looms/
- Published: 2016-12-15T12:00:00.000Z
- Updated: 2026-09-14T21:55:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137583

CDER director **Janet Woodcock** does not appear too concerned with an Administration change next month, saying that for now it is business as usual and the work of the Center goes on. Speaking to [CNBC](http://www.cnbc.com/2016/12/14/fdas-woodcock-speaks-about-one-of-the-agencys-most-controversial-decisions.html?ref=fdaweb.com) reporter **Meg Tirrell**, Woodcock noted that she has been at FDA for over three decades and that administration changes typically see “a difference in philosophy” and there are some administrations that may come in with “certain issues” that they may be interested in. “We regulate safety of drugs, we regulate drugs that are coming onto the market, we regulate generic drugs, and all this needs to keep happening for public health and safety,” Woodcock said.

Asked about the 21st Century Cures Act that was signed into law, Woodcock said she was hopeful it will help with hiring and retaining staff. In a message to Center staff 12/15, Woodcock had high hopes for provisions on patient-focused drug development, qualification of drug development tools, continuous manufacturing of pharmaceuticals, novel clinical trial designs, use of real world evidence in the regulatory setting, and antimicrobial drug development, among others.

Woodcock noted that CDER leadership has been working with the Administration and Congress in providing technical assistance for many of these provisions, “so they are familiar to us. A number of them reflect initiatives we have been working on for many years, such as the qualification processes. By instantiating these in statutory provisions, Congress is effectively making these part of our mission... I believe that the patient-focused drug development and drug development tools provisions will have the most significant impact on our work, in the sense that they will require additional processes and procedures to be put into place. We have begun considering how to do this.”

Asked by Tirrell if she is concerned about whether the approval of Sarepta’s Duchenne drug ([see earlier story](https://www.fdaweb.com/documents-show-how-contentious-woodcocks-exondys-decision-was/)) represents a lowering of approval standards, Woodcock dismissed this and said the approval is representative of how the Center has been operating for years, “but at one end of spectrum.” The Sarepta approval was for a small population and small subset of children with a very serious life-shortening disease, she said, adding that “certainly the way we treat other conditions like hypertension will continue to be quite different.” She said she is not expecting a flood of applications for less rigorously tested drugs, but the Center often sees applications where the development program hasn’t quite crossed the finish line and the companies want to market anyway. “These are tough decisions and always have been, and we expect them to continue to be tough decisions,” she said.