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

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.

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

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 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.

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

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…

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

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

The patient concerns must remain our primary focus.

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.