[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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