[Congressional Record Volume 168, Number 106 (Wednesday, June 22, 2022)]
[Senate]
[Pages S3077-S3079]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. PADILLA (for himself and Mrs. Feinstein):
  S. 4439. A bill to take certain Federal land located in Siskiyou 
County, California, and Humboldt County, California, into trust for the 
benefit of the Karuk Tribe, and for other purposes; to the Committee on 
Indian Affairs.
  Mr. PADILLA, Mr. President, I rise to introduce the Katimiin and 
Ameekyaaraam Sacred Lands Act to place roughly 1,000 acres of sacred 
lands currently under Federal ownership into trust for the benefit of 
the Karuk Tribe.
  The Karuk have lived in and conducted ceremonies on these sacred 
lands known as Katimiin for centuries, and this bill would promote the 
longevity of the Tribe's culture and traditions.
  Our bill would transfer 1,031 acres of Federal land known as Katimiin 
from the U.S. Forest Service to the Interior Department to place those 
lands into trust for the Karuk Tribe. Doing so would allow the Karuk to 
access Katimiin for use during their ancestral ceremonies without 
interruption and exercise better stewardship over their sacred lands 
for generations to come.
  As our Nation works to correct historic injustices, it is important 
that we promote Tribal sovereignty and the continuation of Tribal 
culture. These sacred lands, located in Humbolt and Siskiyou Counties, 
are central to Karuk culture, religion, and identity, and serve as the 
Tribe's center of the universe and site of the Pikyavish world renewal 
ceremony.
  Currently, the Karuk have a special use permit from the Forest 
Service to access the land for prayers and ancestral ceremonies. 
However, in recent years, the Tribe has struggled to access the site 
and conduct their sacred ceremonies privately without interruption. 
Placing these lands into trust would allow the Karuk to provide better 
public notice of ceremonies, preserve traditional practices, and 
protect the land's rich natural beauty, a core tenant of the Tribe's 
identity.
  I thank Senator Feinstein for introducing this legislation with me in 
the Senate and Congressman Huffman for championing this effort in the 
House of Representatives. I also thank the Karuk Tribe, including 
Chairman Attebery, for leading this important effort. I look forward to 
working with my colleagues to enact this bill as quickly as possible.
                                 ______
                                 
      By Ms. COLLINS (for herself and Mr. Kaine):
  S. 4446. A bill to modernize the process of accelerated approval of a 
drug for a serious or life-threatening disease or condition; to the 
Committee on Health, Education, Labor, and Pensions.
  Ms. COLLINS, Mr. President, I rise to introduce the Modernizing the 
Accelerated Approval Pathway Act with my colleague from Virginia, 
Senator Tim Kaine. The Food and Drug Administration's accelerated 
approval pathway has long had broad bipartisan support and is an 
important tool that provides early access to treatments for patients 
with serious and life-threatening conditions for which there is an 
unmet need, like Alzheimer's disease, Duchenne muscular dystrophy, and 
many cancers.
  FDA grants accelerated approval based on substantial evidence that a 
surrogate end point is reasonably likely to predict a clinical benefit. 
In other words, therapies have to meet the same ``substantial 
evidence'' standard as traditional approval, but they can rely on a 
surrogate end point that predicts a clinical benefit rather than 
measuring that clinical benefit directly. For example, a study might 
measure viral load as a surrogate end point for survival in HIV or 
tumor size in oncology.
  This can considerably shorten the time required before a product 
receives FDA approval. Clinical outcomes can take significantly more 
time to manifest than a surrogate end point, and in the meantime, 
patients go without treatments while studies are being conducted. 
Sponsors are still required to complete postmarket studies for their 
accelerated approval products, which are designed to confirm the 
clinical benefit with goals of converting an accelerated approval into 
a traditional approval. A review of accelerated approval drugs approved 
between 1992 and 2016 concluded that 76.5 percent were converted to 
traditional approval.
  The accelerated approval pathway has served us well over the decades 
since it was created in response to outcry over unmet patient need 
during the HIV/AIDS crisis. More than 250 new therapies have received 
accelerated approval, with 65 percent of those therapies treating 
cancer indications and just over 40 percent treating rare diseases or 
conditions. We need, however, to make sure that we update this pathway 
so that it remains flexible in our current scientific environment and 
can continue to enable access to treatments for patients with serious 
and life-threatening conditions who are desperate for a treatment or 
cure.
  It is well known that use of the accelerated approval pathway is 
inconsistent across FDA. Some therapeutic areas, like oncology, have 
vast experience and success using the pathway. In fact, about 85 
percent of accelerated approvals between 2010 and 2020 were for 
oncology indications. In other areas, like neurological diseases, it is 
infrequently used. Patient communities are deeply frustrated by what 
they view as underutilization of the tool and feel it has created 
disparities given that the urgency of finding a

[[Page S3078]]

cure is one shared by all patients with diseases for which there is no 
treatment or cure, regardless of which bureaucratic office leads drug 
review for their particular disease. The Government Accountability 
Office has found that these inconsistencies are due in part to a lack 
of familiarity with the tools of accelerated approval in certain FDA 
centers and divisions. Our bill would correct this by establishing a 
council of senior FDA leadership to ensure consistent and appropriate 
use of the accelerated approval pathway across and within FDA centers 
and divisions.
  Although a number of rare disease therapies have been good candidates 
for accelerated approval, there can also be challenges to using the 
pathway. Sometimes a disease is so rare or heterogeneous that 
developers need to study a small subset of the population in order to 
demonstrate a treatment effect. Our bill would clarify that real-world 
evidence--data from patient registries, electronic health records, 
medical claims, and observational studies--can be used to augment or 
support appropriate post approval studies. This approach may yield 
meaningful and timely evidence that adds context to other data and 
helps us understand how a product works in the real world and across 
the entire population for a disease.
  Some have criticized the timeliness of confirmatory trials, which are 
sometimes delayed by operational or ethical challenges. FDA and drug 
developers are often rushing to agree on a confirmatory trial structure 
late in the review structure, and in those cases they may not be able 
to benefit from expert input or feasibility analyses. This can create 
untenable expectations regarding timelines or, in a worst case 
scenario, result in drug developers pursuing a flawed study that is not 
appropriately designed to confirm clinical benefit. Our bill would 
clarify that FDA may require confirmatory trials to be underway prior 
to approval and that FDA can specify the conditions for those studies, 
which may include enrollment targets, study protocol, milestones, and a 
target date for study completion. Our bill also outlines expedited 
procedures for withdrawing an accelerated approval if a confirmatory 
trial fails to confirm the clinical benefit.
  Finally, we need to make it clearer how much progress an accelerated 
approval product has made toward confirming its clinical benefit. Our 
bill would require that developers of drugs approved under accelerated 
approval submit to FDA a report of the progress they have made on 
required confirmatory trials every 180 days. It would also require that 
if FDA does not require postapproval studies for an accelerated 
approval product, the Agency must publish an explanation on its website 
as to why such a study is not appropriate or necessary.
  Our bill has support from the Juvenile Diabetes Research Foundation, 
American Cancer Society Cancer Action Network, Parent Project for 
Muscular Dystrophy, EveryLife Foundation for Rare Diseases, Alzheimer's 
Association, National MS Society, American Academy of Neurology, 
National Organization of Rare Diseases, and the Haystack Project. I 
thank Health, Education, Labor, and Pensions Committee Chairman Murray 
and Ranking Member Burr for including it in their FDA Safety and 
Landmark Advancements Act, which was favorably reported out of the HELP 
Committee this week. I encourage my colleagues to support that bill 
when it is considered on the Senate floor.
                                 ______
                                 
      By Mr. REED (for himself and Mr. Moran):
  S. 4448. A bill to authorize a pilot program to expand and intensify 
surveillance of self-harm in partnership with State and local public 
health departments, to establish a grant program to provide self-harm 
and suicide prevention services in hospital emergency departments, and 
for other purposes; to the Committee on Health, Education, Labor, and 
Pensions.
  Mr. REED. Mr. President, as we all know too well, rates of suicide 
have risen to epidemic levels in the United States, with suicide now 
the 10th leading cause of death in the country. On average, there are 
130 suicides every day, roughly 1 every 11 minutes. These are 
staggering statistics behind which there are tragic stories of loss. 
That is why I am joining Senator Moran to introduce the Suicide 
Prevention Act.
  Our bipartisan, bicameral bill would provide new resources to help 
turn the tide on this disturbing trend. It would authorize new funding 
for the Centers for Disease Control and Prevention, CDC, partner with 
State and local health departments to improve surveillance of suicide 
attempts and other incidences of self-harm. Data collection efforts 
regarding suicide often occur years after the fact, which limits the 
ability of State and local health departments, as well as community 
organizations, to recognize trends early and intervene. CDC has already 
begun some of this work as a pilot program, but the Suicide Prevention 
Act would expand these efforts and enhance data collection so we can 
respond to new trends quickly and save lives.
  We know that emergency healthcare providers are often at the 
frontlines of responding to suicide attempts. Approximately 37 percent 
of individuals without a previous history of mental health or substance 
abuse who die by suicide make an emergency department visit within the 
year before their death. According to the Suicide Prevention Resource 
Center, the risk of suicide is greatest within a month of discharge 
from the hospital. To help ensure our emergency healthcare 
professionals have the tools to respond, the bill would also authorize 
funding for a grant program within the Substance Abuse and Mental 
Health Services Administration, SAMHSA, to help better train emergency 
department staff to implement suicide prevention strategies, screen at-
risk patients, and refer patients to appropriate followup care. The 
legislation would also require SAMHSA to develop best practices for 
such programs, so that healthcare providers are able to provide their 
patients with the best possible care and advice.
  Nationwide, suicide rates have skyrocketed over the last decade. In 
2020, nearly 46,000 Americans lost their lives to suicide. That same 
year, there were 1.2 million suicide attempts. We must renew our 
efforts on suicide prevention and take a holistic approach. In addition 
to the Suicide Prevention Act, we must reauthorize the Garrett Lee 
Smith Memorial Act, which I am working with Senator Murkowski to do. 
Despite the troubling national trend, programs under this law have 
contributed to declines in the youth suicide rates in my home State of 
Rhode Island over the last decade.
  We must also invest in the National Suicide Prevention Lifeline and 
the new nationwide three-digit 9-8-8 number, which is scheduled to go 
live this summer. Senator Moran and I have teamed up on the National 
Suicide Prevention Lifeline Improvement Act that will increase funding 
for the Lifeline and make key improvements, such as enhance texting 
capability.
  Today, I am pleased to have the opportunity to partner with Senator 
Moran once again by introducing the Suicide Prevention Act. This bill 
is one more step Congress can take to combat the mental health and 
suicide crisis in our country. I look forward to working with Senator 
Moran and advocates in Rhode Island and across the country to make a 
difference in addressing this epidemic.
                                 ______
                                 
      By Mr. CORNYN (for himself, Mr. King, Mr. Sasse, and Mrs. 
        Gillibrand):
  S. 4456. A bill to prohibit certain former employees of the 
intelligence community from providing certain services to governments 
of countries that are state sponsors of terrorism, the People's 
Republic of China, and the Russian Federation, and for other purposes; 
to the Select Committee on Intelligence.
  Mr. CORNYN. Mr. President, I ask unanimous consent to print my bill 
for introduction in the Congressional Record. The bill prohibits 
certain former employees of the intelligence community from providing 
certain services to governments of countries that are state sponsors of 
terrorism, the People's Republic of China and the Russian Federation.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 4456

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

[[Page S3079]]

  


     SECTION 1. PROHIBITION ON EMPLOYMENT WITH GOVERNMENTS OF 
                   CERTAIN COUNTRIES.

       (a) In General.--Title III of the National Security Act of 
     1947 (50 U.S.C. 3091 et seq.) is amended by inserting after 
     section 304 the following:

     ``SEC. 305. PROHIBITION ON EMPLOYMENT WITH GOVERNMENTS OF 
                   CERTAIN COUNTRIES.

       ``(a) Definitions.--In this section:
       ``(1) Covered employee.--The term `covered employee', with 
     respect to an employee occupying a position within an element 
     of the intelligence community, means an officer or official 
     of an element of the intelligence community, a contractor of 
     such an element, a detailee to such an element, or a member 
     of the Armed Forces assigned to such an element that, based 
     on the level of access of a person occupying such position to 
     information regarding sensitive intelligence sources or 
     methods or other exceptionally sensitive matters, the head of 
     such element determines should be subject to the requirements 
     of this section.
       ``(2) Former covered employee.--The term `former covered 
     employee' means an individual who was a covered employee on 
     or after the date of enactment of this section and is no 
     longer a covered employee.
       ``(3) State sponsor of terrorism.--The term `state sponsor 
     of terrorism' means a country the government of which the 
     Secretary of State determines has repeatedly provided support 
     for international terrorism pursuant to--
       ``(A) section 1754(c)(1)(A) of the Export Control Reform 
     Act of 2018 (50 U.S.C. 4813(c)(1)(A));
       ``(B) section 620A of the Foreign Assistance Act of 1961 
     (22 U.S.C. 2371);
       ``(C) section 40 of the Arms Export Control Act (22 U.S.C. 
     2780); or
       ``(D) any other provision of law.
       ``(b) Prohibition on Employment and Services.--No former 
     covered employee may provide services relating to 
     intelligence, the military, or internal security to--
       ``(1) the government of a country that is a state sponsor 
     of terrorism, the People's Republic of China, or the Russian 
     Federation;
       ``(2) a person or entity that is directed and controlled by 
     a government described in paragraph (1).
       ``(c) Training and Written Notice.--The head of each 
     element of the intelligence community shall--
       ``(1) regularly provide to the covered employees of the 
     element training on the prohibition in subsection (b); and
       ``(2) provide to each covered employee of the element 
     before the covered employee becomes a former covered employee 
     written notice of the prohibition in subsection (b).
       ``(d) Limitation on Eligibility for Access to Classified 
     Information.--A former covered employee who knowingly and 
     willfully violates subsection (b) shall not be considered 
     eligible for access to classified information (as defined in 
     the procedures established pursuant to section 801(a) of this 
     Act (50 U.S.C. 3161(a))) by any element of the intelligence 
     community.
       ``(e) Criminal Penalties.--A former employee who knowingly 
     and willfully violates subsection (b) shall be fined under 
     title 18, United States Code, or imprisoned for not more than 
     5 years, or both.
       ``(f) Application.--Nothing in this section shall apply 
     to--
       ``(1) a former covered employee who continues to provide 
     services described in subsection (b) that the former covered 
     employee first began to provide before the date of the 
     enactment of this section;
       ``(2) a former covered employee who, on or after the date 
     of the enactment of this section, provides services described 
     in subsection (b) to a person or entity that is directed and 
     controlled by a country that is a state sponsor of terrorism, 
     the People's Republic of China, or the Russian Federation as 
     a result of a merger, acquisition, or similar change of 
     ownership that occurred after the date on which such former 
     covered employee first began to provide such services;
       ``(3) a former covered employee who, on or after the date 
     of the enactment of this section, provides services described 
     in subsection (b) to--
       ``(A) a government that was designated as a state sponsor 
     of terrorism after the date on which such former covered 
     employee first began to provide such services; or
       ``(B) a person or entity directed and controlled by a 
     government described in subparagraph (A).''.
       (b) Annual Reports.--Not later than March 31 of each year 
     through 2032, the Director of National Intelligence shall 
     submit to the congressional intelligence committees a report 
     on any violations of subsection (b) of section 305 of the 
     National Security Act of 1947, as added by subsection (a) of 
     this section, by former covered employees (as defined in 
     subsection (a) of such section 305).
       (c) Clerical Amendment.--The table of contents immediately 
     preceding section 2 of the National Security Act of 1947 (50 
     U.S. C. 3002) is amended by inserting after the item relating 
     to section 304 the following new item:

``Sec. 305. Prohibition on employment with governments of certain 
              countries.''.

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