Bill Summary
The "Changing the Culture of the FDA Act" is a bill that aims to amend the mission statement of the Food and Drug Administration (FDA) in order to address the growing issue of opioid addiction and overdose deaths in the United States. It directs the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to include a statement in the FDA's mission that highlights their responsibility to consider the risks of addiction and overdose when approving and regulating prescription opioid medications. This legislation is a step towards addressing the opioid crisis and promoting public health.
Possible Impacts
1. This legislation may affect individuals who are taking prescription opioid medications, as it requires the FDA to consider the potential danger of addiction and overdose deaths associated with these medications. This could lead to stricter regulations and guidelines for prescribing and monitoring these medications, potentially impacting their access to and use of these drugs.
2. The legislation could also affect pharmaceutical companies and drug manufacturers, as it calls for the FDA to regulate the manufacturing, marketing, and distribution of opioid medications. This may result in stricter guidelines for the production and promotion of these drugs, potentially impacting their profits and market share.
3. The change in the FDA's mission statement could also have an impact on public perception and awareness of the dangers of prescription opioid use. This could lead to increased education and awareness campaigns, as well as changes in cultural attitudes towards these medications.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 417 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
1st Session
S. 417
To direct the Secretary of Health and Human Services to amend the
mission statement of the Food and Drug Administration.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 7, 2019
Mr. Manchin introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to amend the
mission statement of the Food and Drug Administration.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Changing the Culture of the FDA
Act''.
SEC. 2. MISSION STATEMENT OF THE FOOD AND DRUG ADMINISTRATION.
The Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall amend the mission statement of
the Food and Drug Administration to include the following statement:
``The FDA is also responsible for protecting the public health by
strongly considering the danger of addiction and overdose death
associated with prescription opioid medications when approving these
medications and when regulating the manufacturing, marketing, and
distribution of opioid medications.''.
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