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     &lt;p&gt;&lt;strong&gt;Protecting Access to Safe and Effective Medicines Act of 2021&lt;/strong&gt;&lt;/p&gt; &lt;p&gt;This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining &lt;i&gt;active ingredient &lt;/i&gt;more narrowly as &lt;i&gt;active moiety&lt;/i&gt; in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. &lt;/p&gt; &lt;p&gt;Generally, the FDA defines &lt;i&gt;active moiety&lt;/i&gt; as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an &lt;i&gt;active ingredient &lt;/i&gt;as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting &lt;i&gt;active ingredient&lt;/i&gt; as &lt;i&gt;active moiety&lt;/i&gt; in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.&lt;/p&gt; &lt;p&gt;The bill replaces references to &lt;i&gt;active ingredient&lt;/i&gt; with &lt;i&gt;active moiety&lt;/i&gt; in various statutes authorizing FDA activities.&lt;/p&gt;
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2021-03-12
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-03-11
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-03-11
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-03-11
9
Library of Congress
Introduced in House
IntroReferral
2021-03-11T14:03:45Z
Referred to
House
Energy and Commerce Committee
2021-03-12T15:29:37Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
G000558
2
Brett
Rep. Guthrie, Brett [R-KY-2]
Guthrie
R
2021-03-11
KY
Congressional Research Service, Library of Congress
This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
2021-03-11
2021-03-12
Referred to the Subcommittee on Health.
House
Health
2021-10-19
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
CRS
Related bill
Lower Costs, More Cures Act of 2021
HR
S001180
5
Kurt
Rep. Schrader, Kurt [D-OR-5]
N
Schrader
D
OR
Administrative law and regulatory procedures Chemistry Department of Health and Human Services Drug safety, medical device, and laboratory regulation
2021-03-11
Introduced in House
 <p><strong>Protecting Access to Safe and Effective Medicines Act of 2021</strong></p> <p>This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining <i>active ingredient </i>more narrowly as <i>active moiety</i> in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. </p> <p>Generally, the FDA defines <i>active moiety</i> as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an <i>active ingredient </i>as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting <i>active ingredient</i> as <i>active moiety</i> in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.</p> <p>The bill replaces references to <i>active ingredient</i> with <i>active moiety</i> in various statutes authorizing FDA activities.</p>
2021-05-25T14:05:04Z
00
2021-03-11T05:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr1857ih/xml/BILLS-117hr1857ih.xml
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2023-01-11T13:48:17Z
2023-01-11T13:48:17Z
3.0.0
2021-10-19
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
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2021-03-12
Health Subcommittee
hsif14
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Referred to the Subcommittee on Health.
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2021-03-11
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2021-03-11
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2021-03-11
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2021-03-11
Introduced in House
 <p><strong>Protecting Access to Safe and Effective Medicines Act of 2021</strong></p> <p>This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining <i>active ingredient </i>more narrowly as <i>active moiety</i> in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases. </p> <p>Generally, the FDA defines <i>active moiety</i> as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an <i>active ingredient </i>as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting <i>active ingredient</i> as <i>active moiety</i> in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.</p> <p>The bill replaces references to <i>active ingredient</i> with <i>active moiety</i> in various statutes authorizing FDA activities.</p>
2021-05-25T14:05:04Z
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Protecting Access to Safe and Effective Medicines Act of 2021
Protecting Access to Safe and Effective Medicines Act of 2021
Display Title
IH
Introduced in House
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Official Title as Introduced
IH
Introduced in House
Protecting Access to Safe and Effective Medicines Act of 2021
Short Title(s) as Introduced
2021-03-12
Referred to the Subcommittee on Health.