CATCH THE BUZZ – What’s Next for PLOS? A conversation with outgoing Chief Executive Officer Elizabeth Marincola. And, Who Says It’s FDA Approved? Plus, FDA Approved – Who Says?

Tracy Vence

Elizabeth Marincola

In October, PLOS announced that Chief Executive Officer Elizabeth Marincola will be leaving the nonprofit at the end of this year. The Scientist recently spoke with Marincola about the future of open-access publishing and what we can expect from PLOS following her departure.

The Scientist: You’ve led PLOS for more than three years now. What are some of the highlights of your time with the organization?

Elizabeth Marincola: We have continued to serve our mission, probably most notably in launching a publishing platform we designed and built from the ground up, called Aperta. And it’s meant to be able to substitute for the commercial platforms available that are generally found to be quite unsatisfying, un-user-friendly. So we are very proud of that, and we already have many publishers who are eager to get their hands on it.

In addition, we have rolled out an open-data policy that we feel really has led the way in terms of demanding that all relevant published research be made available. And we require ORCID IDs in order to facilitate credit for all research that is published. Those are just a few of the advances we’ve made in the three-and-a-half years I’ve been at PLOS, and I’m really proud of our whole team.

TS: Let’s talk about PLOS, the publishing company. Several other open-access publishers have joined the fray since the early 2000s. What is PLOS’s place in today’s open-access publishing marketplace?

EM: The first and primary mission of PLOS when it was founded was to make the case that open-access publishing could be a sustainable business, whether in a nonprofit environment or a for-profit environment. So the very fact we have a lot of competition now is extremely satisfying to us and it is, in itself, a major part of our vision. As Harold Varmus said when he cofounded PLOS, if we could put ourselves out of business because the whole world becomes open-access STM publishing, that would be the greatest testament to our achievements.

Our place continues to be as a global leader both in open-access publishing and in pushing the boundaries of transparency in scientific communication. We are working very hard to create an environment in which work can be published immediately, which will enable us to eliminate the time-to-publication that currently means much research is held up for months while it is under review. So our intention is to continue to push those boundaries, to set an example for other open-access publishers, while at the same time continuing our business of open-access publishing.

TS: You mentioned time-to-publication as one barrier. Generally speaking, what are some of the greatest challenges in open-access publishing today? 

EM: There are several. Time-to-publication still is a barrier to getting research out immediately. We are seeing evidence of people submitting papers that are fraudulent in some way or another, or otherwise push ethical boundaries. That’s not exclusive to open-access publishing, but there is the problem of people submitting papers that aren’t good. We continue to be committed to publishing all valid research in PLOS ONE, so to the extent that we can remove the barrier of time-to-publication and the barrier of selectivity, we will be continuing to push our boundaries.

TS: Those familiar with Reddit’s r/Science forum are tuned into PLOS Science Wednesdays. Can you tell us a bit about that partnership, and what has come of it to date?

EM: It’s been wonderfully successful. We invite an author, an editor, [or] some other interesting, engaging science figure who has a relationship with PLOS, and they do an “Ask Me Anything.” We have many, many people follow along. We are so pleased that it has been a successful forum for getting science out to the public.

TS: Other than a search for the next CEO, what else can we expect to see from PLOS in the coming months?

EM: We will be launching the rest of our journals on our Aperta platform. That will be very exciting for us. We also have introduced advance online publication, to be able to post immediately accepted papers. . . . I think that may be the final shoe to drop in terms of being able to serve our mission to create full transparent science.

Plus, Who Says It’s FDA Approved?

“FDA approved!”

Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?

FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

But not all those products undergo premarket approval — that is, a review of safety and effectiveness by FDA experts and agency approval before a product can be marketed. In some cases, FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has regulatory authority to act when safety issues arise.

Here is a guide to how FDA regulates products — and what the agency does (and doesn’t) approve.