I'm very concerned about data exclusivity.

Do you believe, as prior commissioners have--every one has told me this--that the Dietary Supplement Health and Education Act, DSHEA, provides adequate authority to regulate the dietary supplement industry and protect consumers from unsafe…

FDA's proposal to regulate LDTs is a significant change that would impose considerable new burdens on regulated parties.

The average cost, according to what I've been told, for a pharmaceutical drug is about a billion dollars...

One issue that significantly affects many entities in my home State is the FDA's October 2014 proposed guidance on the regulation of LDTs, laboratory-developed tests.

Today, we are here to explore the various issues surrounding the growth and prevalence of Physician-Owned Distributors, or PODs.

If we reduce that data exclusivity time, especially with regard to bio, you're talking about having to charge a lot more...

If we don't allow enough data exclusivity time, we're not going to develop these therapies, especially in bio, because bio is one of four or five places, four or five techniques, where we can actually find treatments and cures.

I hope that today's hearing will be another important step in our ongoing efforts to provide appropriate oversight and enforcement on this issue.

the fraud and abuse risks, as well as (and more importantly) the patient safety concerns related to PODs, are equally applicable to physician-owned O&P laboratories.

I think we have assumed a disproportionate responsibility for global security in the United States.

The patient has a right to know, and then, of course, taxpayers, because you have public payers, the people of this country, through the Medicare program.

We believe these findings will say quite a bit about the lack of accountability for these types of business relationships or arrangements.

Simply put, PODs are medical device businesses in which a physician is both an investor and a distributor--essentially a salesperson--of either the devices or some of the components.

While these arrangements are not always problematic, we are seeing more and more of these physician-salespeople using the very devices they sell in the surgeries and procedures they perform.

I'm very pleased to be able to support your nomination. I'm very impressed with what you've been able to do...

All Americans deserve quality healthcare throughout their lives.

I think it is important to talk about other reforms to SSDI, but I do want to highlight the fact that the private group long-term disability insurance, according to one study, already saves federal programs $2 billion a year.