Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “FDA Rolls Out New Rx-Use-App Paper,” by Mohana Ravindranath.

Following is an excerpt:

Many apps that offer information about prescription drug use wouldn’t require FDA approval before going on the market, the agency proposed in a new concept paper Monday.

Apps offering or tracking basic information, such as symptom trackers, wouldn’t require agency pre-approval, but would need to meet post-market requirements for promotional drug labeling. But apps offering significant changes to clinical outcomes would likely require more review. The agency thinks most of these apps would fit the former category.

Products that have already been reviewed by the agency’s device center likely wouldn’t face scrutiny from the drug office.

Developers had long griped about differences in standards between the agency’s drug and device offices, and the proposal — a prelude to later draft guidance — addresses that.

Bradley Merrill Thompson of Epstein, Becker and Green said he was glad the agency was starting to address the subject, but he still expressed significant reservations. The proposal only covers apps developed by drug sponsors in conjunction with their products, and Thompson says that independent companies need attention too.

“It is, though, nice to see the agency start to publish anything on software used with pharmaceutical products,” he wrote. “We just hope that we will see more soon.”

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.