Frank Pallone

As you know, Representative Blackburn has introduced a bill, H.R. 3303, that would create an entirely new regulatory framework for medical software.

I appreciate that we have the opportunity today to discuss the SOFTWARE Act.

I think it is fair to say that we all want to encourage continued innovation, but it is also important that we shepherd these emerging technologies...

The possibilities for mobile health technologies are promising and exciting and there are so many functions that mobile health applications can be designed for...

FDA's guidance is very measured and risk-based.

I introduced a bill last year that included a provision to do just that and I have long been an advocate for the structural change within FDA to enhance the role of the Office of Generic Drugs.

These provisions were based on the ideas and proposals contained in the Drug Safety Enhancement Act, which I introduced with Mr. Dingell, Mr. Waxman, and Ms. DeGette.

It is important that American consumers have access to these safe, effective, and low cost alternatives more quickly, which is why the provisions in the generic drug user fee agreement were so important.

The user fees are an essential component of FDA's funding. They help to ensure a predictable and efficient review process so that the American public has access to safe and effective healthcare products.

I am eager to hear your testimony about FDA's progress in implementing the Food and Drug Administration Safety and Innovation Act, or FDASIA.

The fact is more than 50 percent of people left their coverage in this market after 1 year and over 80 percent left after 2 years.

If the Republicans think that--and Dr. Burgess said it that the reimbursement rate is too low and that is why doctors don't want to take Medicaid, then raise the reimbursement rate.

I think this whole thing is very ideologically driven. They don't like Medicaid, they don't want to expand Medicaid.

But here are the facts. Americans who have insurance through their employers or Medicare or Medicaid will keep their current coverage.

However, it is obvious to all that there are great challenges when a program like this gets going.

The law is also slowing the growth in healthcare costs.

These are significant signs of progress. They show we are on our way to dramatically expanding health insurance coverage in this Nation.

Because of the Affordable Care Act millions of Americans who would have gone uninsured will have coverage.

The Affordable Care Act has always aroused strong passions among opponents and defenders of the law, and as a supporter of the law, I see it as part of one of my core missions in public life; to help every American get access to quality…

The reason why Medicaid is not being expanded in a lot of States is because Republican governors have refused to expand it, but they are not coming up with an alternative.

The law is allowing millions of uninsured and underinsured Americans to gain access to comprehensive healthcare coverage.

Obamacare, and I won't call it that, the Affordable Care Act is not an accident. It was purposely signed into law because Democrats, unfortunately not Republicans, believe that they could make a difference in improving the healthcare…

I know we're not in Kansas, but I do believe increasingly we're in Oz because of what I see here.

In New York and Washington, over 30,000 people have enrolled in coverage.

That is all it is, hoping people won't apply.