Replies to post #307550 on Bioelectronics Corp (BIEL)

[JNdouble1]

CMS was not cited in either of the previous references.
You have done so now, so good for you.

So you think we will hire lobbyists?

[GetSeriousOK]

Umm-WRONG-Again. Your first two links cited FDA ONLY. It was post 307542. Here they are again:

https://scholarworks.merrimack.edu/cgi/viewcontent.cgi?article=1003&context=fin_facpub
https://www.opensecrets.org/federal-lobbying/agencies/summary?id=135

And let's look closer at those, shall we? They don't talk about lobbying the FDA -- they talk about lobbying legislators.

The Center for Responsive Politics (CRP) data show pharmaceutical firms spend more than $1.6 billion lobbying the Congress and the Obama administration for the 7-year span from 2009 to 2015.

Based on our sample, in 2010, about 43 percent of pharmaceutical firms are actively engaging in lobbying by spending over 177 million dollars aiming at influence on over 1,400 bills in favor of their products. Given the nature of motivation for lobbying, it is plausible to expect that active lobbying positively influences outcome of the FDA approval.

I see that there's confusion here about what a lobbyist IS and what a lobbyist DOES and WHO a lobbyist works with.

[GetSeriousOK]

Umm - WRONG -Again. Your previous links had no mention of CMS, and this one is for FDA breakthrough devices only. It has nothing to do with LOBBYISTS working with the CMS. Any lobbying done here would be with legislators, trying to get a bill passed. THAT's what lobbyists do.

AdvaMed CEO Scott Whitaker said the idea is for CMS to take products FDA awarded a breakthrough device designation and have them be reimbursed by Medicare when approved. If needed, during a temporary period of time, device companies could continue to build evidence for their products, he said.

[GetSeriousOK]

Assume that Kelly submits a 510(k) for the indication of phantom pain. She hires a lobbyist to help get this 510(k) cleared. Does the lobbyist directly contact the FDA Lead Reviewer?

or does the lobbyist contact the Lead Reviewer's supervisor?

Thanks!