I rise today to introduce the Stem Cell Therapeutic and Research Reauthorization Act of 2015. I am glad to have Senators Reed, Burr, and Franken joining me as sponsors of this bipartisan bill that will reauthorize critical, innovative, and…

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.

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.

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

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

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…

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

There is really an urgent need for more transparency.

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

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.

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

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.

the proliferation of PODs and the lack of guidance as to how these arrangements square with existing Federal law.

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

All Americans deserve quality healthcare throughout their lives.

I ask unanimous consent that I be permitted to finish these remarks. The PRESIDING OFFICER. Is there objection? Without objection, it is so ordered.

I rise today to speak once again on the topic of religious liberty. This is the fifth in a series of addresses I have given on this vitally important subject. In my previous remarks, I have discussed why religious liberty matters, why it…

Before the Supreme Court, the administration made the remarkable claim that Federal law authorizes the Federal Government to involve itself in the hiring and firing of church ministers. Specifically, the administration said that Federal…