Comparative effectiveness will boost R&D: Woodcock

Share this article:
The FDA's director of drugs, Janet Woodcock, believes the movement toward comparative effectiveness research will lead to a more internationally harmonized drug development process. Speaking at the Food and Drug Law Institute's annual meeting in April, Woodcock said that as comparative effectiveness data become more standard and relied upon by national payer systems and insurance companies, related clinical study principles will be forced into the development program.

“So the development program is going to be expected not only to accomplish demonstrated effectiveness but also have more input in placing the drug in the armamentarium and deciding the value of the therapy,” she said. Regulatory authorities will not be the ones mandating changes to drug development programs, Woodcock said—instead, it will be driven by national payer systems and insurance payers.

“So I think there is going to be a period of transition over the next 10 years and we are going to see a very different approach to development programs.”

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?