Joe Pitts

One of the most striking features of this year's budget is just how much of it is not dependent upon Congress.

I vowed to be good today, but someone on the other side took the first shot...

I keep hearing from people, industry has even said, can you slow down, you are putting too much stuff.

This is not House Republicans, this is the President's Jobs Council. This is the administration that is voicing concern with the predictability and consistency within the FDA.

Our medical innovation system is in jeopardy. Investment in life science area is declining at an alarming rate because of the escalating cost, time and risk of developing new drugs and devices.

Five years ago, the committee passed the reauthorization of the medical device user fee, and when we voted for that bill, we did so expecting that FDA would meet its end of the deal.

Frankly, we don't have 20 years or even 6 months to wait for FDA to fix the problems.

We worry about the jurisdictional creep that has been going on where you seek to grab as much regulatory territory as possible.

What is best for patients and what is best for jobs is to have a device review process that is clear, transparent, predictable and accountable, and I hope that that is what the proposed agreement accomplishes.

Look, no physician wants to tell a patient that they cannot receive the care they need because there is no treatment but because the product is simply not available and we won't provide alternatives is no solution at all.

Statement, dated February 9, 2012, of American Society of Health-System Pharmacists, submitted by Mr. Pitts.

Statement, dated February 9, 2012, of American Academy of Pediatrics, submitted by Mr. Pitts.

This is the kind of issue that can and should be tackled on a bipartisan basis.

Statement, dated February 9, 2012, of National Community Pharmacists Association, submitted by Mr. Pitts.

Statement, dated February 7, 2012, of the Biotechnology Industry Organization, submitted by Mr. Pitts.

To close on our side, I yield such time as he may consume to a distinguished member of the Health Subcommittee, the gentleman from Georgia, Dr. Gingrey. The Acting CHAIR. The gentleman from Georgia is recognized for 4 minutes.

I believe we have the right to close, and we have just one speaker. I reserve the balance of my time.

I continue to reserve the balance of my time. The Acting CHAIR. The gentleman from New Jersey has 2 minutes remaining. The gentleman from Pennsylvania has 4 minutes remaining.

It is unconscionable to promise something to people when you know it won't be there. Your own administration admits the CLASS Act doesn't work. Zero people will be enrolled in the CLASS Act. They have a program that does not work, a…

A lot of folks where I come from, they can't afford a $50 substitute for a $20 product that they have been taking for way too many years.

I would ask or suggest that you look into resolving this issue by considering releasing the remaining units of Primatene Mist.

It is estimated it is costing our government, the federal government, between $300 million and $1.1 billion due to asthmatics' increased hospitalizations.

I represent a very large, a very rural, a very poor district, and Primatene Mist can be purchased over the counter for asthmatic patients for 20 bucks.

As a father and grandfather, I view reauthorizing BPCA and PREA as a step toward obtaining that data and ensuring that our children and grandchildren receive the correct medications and correct dosages when they are ill.

The strong risk aversion at the FDA is creating at least the perception that it is slowing down or stopping the approval of new, innovative treatments for cancer and other life-threatening terminal diseases.