Bill Text: NJ AR142 | 2016-2017 | Regular Session | Amended

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Bill Title: Commemorates and expresses approval of enactment of legislation by President and Congress adding Zika Virus Disease Priority Review Voucher Program.*

Spectrum: Partisan Bill (Democrat 7-0)

Status: (Passed) 2016-05-26 - Filed with Secretary of State [AR142 Detail]

Download: New_Jersey-2016-AR142-Amended.html

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[First Reprint]

ASSEMBLY RESOLUTION No. 142

STATE OF NEW JERSEY

217th LEGISLATURE

 

INTRODUCED APRIL 14, 2016

 

 

Sponsored by:

Assemblyman  GARY S. SCHAER

District 36 (Bergen and Passaic)

Assemblywoman  VALERIE VAINIERI HUTTLE

District 37 (Bergen)

Assemblywoman  NANCY J. PINKIN

District 18 (Middlesex)

Assemblyman  JAMEL C. HOLLEY

District 20 (Union)

Assemblywoman  ANGELA V. MCKNIGHT

District 31 (Hudson)

 

 

 

 

SYNOPSIS

     Commemorates and expresses approval of enactment of legislation by President and Congress adding Zika Virus Disease to list of tropical diseases included in FDA Tropical Disease Priority Review Voucher Program.

 

CURRENT VERSION OF TEXT

     As reported by the Assembly Health and Senior Services Committee on May 12, 2016, with amendments.

  

An Assembly Resolution ¹[urging the United States Food and Drug Administration to add] commemorating and expressing approval of the enactment of legislation by Congress and the President of the United States adding¹ the Zika virus to the list of ¹[qualified Neglected Tropical Diseases under] tropical diseases included in¹ the ¹United States Food and Drug Administration¹ Tropical Disease Priority Review Voucher Program.

 

Whereas, The Centers for Disease Control and Prevention (CDC) defines the Zika virus (Zika) as a disease caused by a viral infection that is spread to people primarily through the bite of a mosquito; and

Whereas, The illness associated with Zika is usually mild with symptoms such as rash, fever, joint pain, and pinkeye lasting for several days to a week, and people usually do not get sick enough to require hospitalization; and

Whereas, Due to Zika's mild symptoms, many people who contract the disease never realize that they have been infected; and

Whereas, According to health experts, Zika represents a significant danger to pregnant women because of a rise in detected cases of congenital malformations and neurological complications among infants born to women infected with the disease, which cause children to be born with abnormally small heads and potential developmental problems; and

Whereas, ¹[On] In¹ May 2015, the Pan American Health Organization issued an alert regarding the first confirmed case of Zika in Brazil, and on February 1, 2016, the World Health Organization (WHO) declared that the Zika outbreak and its connection with congenital malformations and other neurological disorders in South America meet the conditions for a Public Health Emergency of International Concern; and

Whereas, The WHO advised affected and at-risk countries that surveillance is necessary in order to minimize the effect of the Zika outbreak and to reduce the risk of further international spread; and

Whereas, Since Zika was first detected in Brazil in May 2015, the disease has spread to at least 31 countries and territories in the Americas and has made its way to the United States with the potential to infect millions of people; and

Whereas, ¹[Under federal law, the] The¹ United States Food and Drug Administration (FDA) ¹[is statutorily authorized to add Neglected Tropical Diseases (NTDs) that are emerging as new public health threats to] currently administers¹ the FDA Tropical Disease Priority Review Voucher Program (voucher program) ¹[without obtaining Congressional approval]¹; and

Whereas, The voucher program incentivizes a drug company to find a cure for ¹[an NTD] certain tropical diseases¹ while at the same time obtaining a voucher from the FDA; and

Whereas, A drug company may use the voucher to obtain a priority review from the FDA for approval of a new drug of their choice or they can sell the voucher to another drug company; and

Whereas, ¹[In 2015, the FDA utilized its authority to add two diseases to the voucher program, and on February 5, 2016, a letter--signed by more than 70 members of Congress--urging the FDA to add Zika to the list of NTDs eligible for the voucher program was delivered to the Acting Commissioner of the FDA] On April 19, 2016, the President of the United States signed into law Pub.L. 114-146, which added Zika virus disease to the list of tropical diseases included in the voucher program under 21 U.S.C. s.360n¹; and

Whereas, ¹[In the letter, the members of Congress expressed the opinion that by adding Zika to the list of eligible NTDs under the voucher program, "the FDA could spur development of an effective vaccine or treatment against Zika virus, and as a result save countless American lives;" and

Whereas, It is imperative, therefore, that the FDA Commissioner exercise his statutory authority to add Zika to the list of qualified NTDs under the voucher program in order to prevent or lessen future outbreaks of Zika and its detrimental health outcomes on infants] It is the sentiment of this House that the enactment of Pub.L. 114-146 by the President and Congress of the United States represents a significant step in aiding ongoing efforts to combat the spread of Zika and limit the potentially devastating effects of the disease¹; now, therefore,

 

     Be It Resolved by the General Assembly of the State of New Jersey:

 

     1.    The General Assembly of the State of New Jersey ¹[respectfully urges the Commissioner of the United States Food and Drug Administration (FDA) to add] commemorates and expresses its approval of the enactment of Pub.L. 114-146 by the President of the United States and Congress, thereby adding¹ Zika virus disease to the list of ¹[eligible Neglected Tropical Diseases under] tropical diseases included in¹ the FDA Tropical Disease Priority Review Voucher Program.

 

     2.    Copies of this resolution, as filed with the Secretary of State, shall be transmitted by the Clerk of the General Assembly to the ¹[Commissioner] President¹ of the United States ¹[Food and Drug Administration] , the Majority and Minority Leaders of the United States Senate, the Speaker and Minority Leader of the United States House of Representatives¹, and to every member of the New Jersey's Congressional delegation.