Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, was quoted in an article titled "Combination Product Group Calls For New FDA Policy on Two Kinds of Tests."

Following is an excerpt:

The Food and Drug Administration needs to take action and make a decision on whether it has the authority to regulate laboratory developed tests (LDTs) as medical devices, a group representing manufacturers of combination products said in a recent letter to the agency.

The Combination Products Coalition (CPC) May 15 told the FDA it needs to make a decision about regulating LDTs and in-vitro diagnostics (IVDs). According to the letter, the FDA's approach to lab-developed tests and the FDA's approach to IVDs can't both be correct. Either the federal government is dramatically overregulating IVDs, or underregulating lab-developed tests, or both, the group said.

The group called on the FDA to create a single regulatory system for both IVDs and LDTs. ?...

Bradley Merrill Thompson, an attorney with Epstein Becker & Green, P.C. in Washington and general counsel to the CPC, told Bloomberg BNA May 19 the group decided to act because it appeared that all IVD/LDT-related efforts at the FDA "have ground to a halt."

Thompson said, "We've been waiting and waiting for a [final] guidance on companion diagnostics. Our understanding is that it's being held up" at the White House Office of Management and Budget because of unresolved concerns about LDT regulation. The CPC letter calls on the guidance to be released, and for other agencies to "step aside" if they are holding up its release.

Sending a letter "was the best approach we could think of. It's pure and simple frustration. I don't see how this gets resolved without FDA being more bold" about making a decision, Thompson said. ?...

Thompson said nothing can be done about the regulations without Congress getting involved, but as a minimum first step, he said the agency needs to act, and come out with a policy.

"Then we can have a discussion with Congress, get everyone talking," Thompson said. "I want to have a debate. I'm convinced that once the debate starts, we will get somewhere. It all starts with FDA. FDA can't walk around wringing its hands. Doing nothing can't be good for patients. There's no way the current system puts patients first."

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.