FDA chief cites the need for more collaboration

Share this article:
Margaret Hamburg
Margaret Hamburg

FDA commissioner Margaret Hamburg told the Institute of Medicine's Forum on Microbial Threats in December that if academia, industry, government scientists and regulators could come together more in pre-competitive collaboration it could get more done, particularly in important, targeted areas.

Although there's a tradition of FDA keeping a protected distance in its regulatory role, she said that at times this has been at the expense of getting the job done. There are areas, Hamburg stated, where the agency needs to work with others.

Hamburg indicated that this is a critical time for infectious disease issues. The country has made remarkable progress against some, including HIV, but it has lost ground on others.

She also pointed out that many problems thought to be chronic disease have turned out to be related to infectious disease processes. She noted that dangerous pathogens can now be grown or produced with simple techniques in labs and people can be exposed inadvertently.

Complacency about infectious diseases, as public interest waxes and wanes, is the greatest danger, Hamburg added. With the “compelling and urgent need,” to develop drugs for infectious diseases, she said she has focused on using science to make sure products get on the market. And yet the number of anti-infectives in the pipeline is, “distressingly low.”
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

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?