Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019

Floor Speech

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Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 269) to reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

The Clerk read the title of the bill.

The text of the bill is as follows: H.R. 269

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Mr. PALLONE. 269.

I rise to voice my support for the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019. This legislation will help strengthen our Nation's emergency preparedness and response efforts. It will also modernize the regulatory framework for over-the-counter drugs and provide FDA with stable and consistent funding to oversee the over-the-counter market.

This bill would ensure our Nation is prepared and can respond to emerging infectious disease threats, including Zika and Ebola. It will also prepare us so we can better respond to health security events, like bioterrorism and natural disasters such as hurricanes and wildfires.

The importance of this law cannot be overstated, Mr. Speaker. That is why our committee committed to working together in the last Congress on a bipartisan basis to ensure that the important authorities granted to the FDA in this law did not lapse.

I want to especially thank Representatives Eshoo and Brooks for their work on this legislation and their leadership in promoting the importance of strengthening our Nation's emergency preparedness and response infrastructure.

While the House passed legislation that would have prevented this authorization from expiring, the Senate then refused to act and, instead, allowed these important authorities to expire on September 30.

While we were disappointed that we were unable to reauthorize PAHPA before that occurred, we continued to work with our Senate colleagues on moving this important legislation forward before the end of the 115th Congress. That effort led to the passage of H.R. 7328 on December 20, legislation developed as a result of bipartisan, bicameral negotiations to reach agreement on a PAHPA reauthorization bill that we could all support.

Unfortunately, just like before, the Senate did not act; and, thus, we are on the floor again today, Mr. Speaker, moving legislation to reauthorize the Pandemic All-Hazards Preparedness Act and pass historic legislation to streamline and fund the regulation of over-the-counter drugs. I hope that the third time will be the charm and that our Senate colleagues will act quickly to pass this legislation.

In addition to reauthorizing our public health preparedness and response programs, this legislation also contains a bipartisan and bicameral agreement reforming our over-the-counter drug program.

The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 has also twice previously passed the House with overwhelming bipartisan support. It modernizes the way the FDA reviews over-the- counter products for colds, allergies, and other common health issues.

The bill streamlines the review process for future monograph changes, allows for expedited safety label changes, and establishes a user fee program to provide reasonable or sustainable resources to implement these reforms.

These are all critical changes that I am very proud to support.

While this is not a perfect bill and still contains unnecessary and unwarranted exclusivity for over-the-counter drugs and sunscreens, reform of our over-the-counter drug program is long overdue. This reform will pave the way for innovation in the over-the-counter market, allow the agency to respond to safety events, and finally provide the agency with the resources needed to properly oversee this growing market.

This legislation has the broad support of industry, public health groups, and the FDA, and it deserves the support of both the House and the Senate.

I want to thank the bill's authors, Representatives Eshoo, Brooks, DeGette, Latta, Dingell, Guthrie, and Burgess, for their hard work on this legislation.

It is my hope that the Senate will now take swift action and move this legislation to the President's desk. I urge my colleagues to vote in support of this legislation.
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Mr. PALLONE. Mr. Speaker, I have no additional speakers, and I reserve the balance my time.

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Mr. PALLONE. Mr. Speaker, I have no additional speakers and am prepared to close.

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Mr. PALLONE. Mr. Speaker, again, I would ask support for this bipartisan bill. It is very important legislation, and I hope that we can send it to the Senate and have the President quickly sign it.

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Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.

The yeas and nays were ordered.

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