Michael Burgess

I will never get to all the questions I have. I am going to submit some in writing.

So the answer is no, there are no contingency plans? We are not paying attention to current events surrounding our agency, and if the world comes crashing down around our ears on June 30th, so be it.

If we are willing to spend more money to have top researchers in their field, we must have oversight into how those dollars are spent.

Did I hear you right when you said that?

This is the equivalent of taking the Fifth on this issue.

We are serious about conducting meaningful oversight of federal agency budgets financed on the backs of hardworking American taxpayers.

It is imperative that we maintain stringent oversight of these dollars to ensure that this money is working for the public to protect both their physical and economic health.

If there is the ability either with the racing commissioners or within your professional organizations to deal with this, just in my experience, you are so much better doing that than asking the United States Congress to get involved.

I wonder if I might have just one follow-up question with Mrs. Jackson.

I also want to acknowledge the work of Chairman Whitfield when he was our subcommittee chairman on Oversight and Investigations.

I just want to appreciate the fact that I was able to simulcast from Texas because Texas is also horse country.

Sometimes it occurs to me that maybe we have tightened things down too much.

So we are expanding government in the process of doing this.

We have heard from many stakeholders that the provisions that were put in place have limited FDA's ability.

Yes, but this is something that people just frankly do not understand why one federal agency and another federal agency cannot come together on a reasonable solution.

I appreciate the fact that you are working through this problem with getting a new over-the-counter preparation available, but as you pointed out, you have difficulty with bioequivalency.

But one specific instance, of course, a shortage occurs right now today at any pharmacy across the country that an asthmatic cannot walk into a pharmacy and buy an over-the-counter asthma inhaler like they used to be able to before January…

Substantial equivalence does not necessarily equate clearance, and your own information that you sent to a company that receives a substantial equivalence determination, 'Please be advised the FDA's issuance of a substantial equivalence…

I don't understand, why would you not issue a mandatory recall immediately?

The patient concerns must remain our primary focus.

We need to reauthorize the user fees by the end of June to assure continuity at the FDA and increase predictability for America's medical innovators and job creators.

I think we all agree that fostering innovation helps American patients and aids in creating American jobs.

It seems like we could do this if we just had the political will to take it.

My personal feeling is the Tax Code is not the proper means for achieving those.

I think that there is a lot of the American electorate, a lot of the American people, feel that simplifying the tax system should be one of our highest priorities.