US FDA User Fee Riders Make It Across The Line: A Guide To The Food And Drug Omnibus Reform Act (FDORA) – Healthcare

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, a $1.7
trillion omnibus that will fund the federal government through the
remainder of fiscal year 2023. Tucked in the 4,126-page legislation
is a package of US Food and Administration (FDA)
“riders”—deemed the Food and Drug Omnibus Reform
Act, or “FDORA”—most of which were originally
floated for inclusion in legislation that reauthorized the FDA User
Fee Acts (UFA) for prescription drugs, medical devices, generic
drugs, and biosimilars.

After negotiations stalled this summer, Congress passed a
“clean” UFA reauthorization on September 30, under the
FDA User Fee Reauthorization Act of 2022 .
Although the Act reauthorized the UFAs for five years, it extended
other FDA programs and initiatives through December 16, 2022 (under
subsequent legislation, extended to December
23, 2022). The expiration of these FDA programs created a critical
opportunity for Congress to reconsider the riders as part of the
end-of-year Omnibus package.

Ultimately, many (but not all) of the proposed riders were
included in FDORA. For example, the omnibus strengthens FDA’s
authority to regulate cosmetic products, reforms the accelerated
approval pathway, and includes several policies intended to
increase diversity in clinical trials. FDORA also includes a
provision that is intended to partially reverse the DC Court of
Appeals decision in Genus Medical Technologies v. FDA
(which held that FDA could not classify any product, including the
contrast agent at issue in the case, as a drug when it also meets
the definition of a device) for most affected products.

Despite an intense push to clarify FDA’s authority over
diagnostic tests, the Verifying Accurate Leading-edge IVCT
Development (VALID) Act was not included in the omnibus, after
facing opposition from stakeholders (including academic medical
centers) as well as a reluctance by certain members to increase
FDA’s authority. It will be important to monitor FDA’s
response. Commissioner Robert Califf has indicated that the agency
will lean harder on its existing authorities, which could include
rulemaking. In addition, another top FDA Center for Devices and
Radiological Health official has stated that “FDA believes
that enforcement discretion policy no longer makes sense
here,” suggesting a major shift in the way the agency
regulates laboratory developed tests.

The omnibus also does not include dietary supplement listing
requirements, proposals related to drug importation, or a proposal
intended to reverse the Eleventh Circuit’s decision in
Catalyst Pharmaceuticals, Inc. v. FDA related to the scope
of orphan drug exclusivity vis-à-vis a drug’s orphan
designation and approved orphan indications. Also absent are
several FDA-related provisions from the CURES 2.0 Act, including a
codification of the Medicare Coverage of Innovative Technology
(MCIT) Final Rule, which would create a Medicare coverage pathway
for innovative technologies. These items could draw additional
consideration from the 118th Congress, but they are not seen as
urgent priorities among relevant House and Senate leadership.

A summary of the relevant FDA provisions is below:

Development and Review of Medical Products

These provisions seek to support the development and review of
medical products.

  • Section 2501. Accelerating countermeasure development
    and review
    . Codifies FDA’s Coronavirus Treatment Acceleration

  • Section 2502. Third party test evaluation during
    . States that FDA has the authority to consult
    and contract with third parties when evaluating and making
    recommendations regarding in vitro diagnostic tests offered for use
    during a public health emergency. Also requires FDA to issue
    guidance on such consultations.

  • Section 2503. Platform technologies. Requires
    FDA to create a designation program for “platform
    technologies.” Platform technologies are technologies that
    have the potential to be incorporated in or used by more than one
    drug or biological product and are reasonably likely to make the
    drug development or manufacturing process and the review process
    more efficient. If FDA designates a platform technology as a
    designated platform technology, FDA “may expedite the
    development and review of any subsequent application submitted
    under Section 505(b) of [the Food, Drug, and Cosmetic] Act or
    Section 351(a) of the Public Health Services Act for a drug that
    uses or incorporates the platform technology.” Sponsors may
    also “reference or rely upon data and information” from a
    previous application for a drug or biological product that
    incorporates or uses the same platform technology—as long as
    the data was submitted by the same sponsor or the sponsor relying
    on the data received permission from the sponsor who originally
    submitted the data. Also requires FDA to issue guidance relating to
    the program.

  • Section 2504. Increasing EUA decision
    . Permits FDA to release to the public more
    safety and effectiveness information about products authorized for
    emergency use.

  • Section 2505. Improving FDA guidance and
    . Requires FDA to issue a report
    “identifying best practices for the efficient prioritization,
    development, issuance and use of guidance documents” and
    develop a plan to implement such best practices. It also requires
    FDA to release a report on the agency’s communications with
    medical product sponsors and other external stakeholders and a plan
    for implementing the best practices identified in the report.

Mitigating Shortages of Medical Products

These provisions seek to resolve issues relating to shortages of
medical products.

  • Section 2511. Ensuring registration of foreign drug and
    device manufacturers
    . Clarifies that all foreign drug and
    medical device establishments that manufacture or process drugs or
    medical devices imported or offered for import in the United States
    must register with FDA, including products that undergo further
    processing at another establishment outside the United States prior
    to being imported or offered for import into the United

  • Section 2512. Extending expiration dates for certain
    . Requires FDA to issue or revise guidance to address
    recommendations for drug sponsors regarding submission of stability
    testing data in applications, “establishing . . . the longest
    feasible expiration date scientifically supported by such
    data,” and “the use of innovative approaches for drug and
    combination product stability modeling to support initial product
    expiration dates and expiration date extensions.” Also
    requires FDA to submit a report to Congress providing the number of
    drugs for which the Secretary has requested a change to the
    expiration date and information regarding the circumstances of such

  • Section 2513. Combating counterfeit devices.
    Establishes additional actions that qualify as prohibited acts and
    increases the penalties for selling counterfeit medical devices in
    the United States.

  • Section 2514. Preventing medical device
    . Gives FDA authority to receive voluntary
    notifications from manufacturers of certain medical devices
    regarding a discontinuance in the manufacture of the device or an
    interruption of manufacture likely to lead to “a meaningful
    disruption in the supply of that device in the United States.”
    Also requires FDA to issue guidance relating to such voluntary


Sections 3101-3109 reauthorize the Critical
Path Public-Private Partnership; the best pharmaceuticals for
children program; the humanitarian device exemption incentive; the
pediatric device consortia program; provision pertaining to drugs
containing single enantiomers; certain device inspections; orphan
drug grants; reporting requirements related to pending generic drug
applications and priority review applications; and the third-party
device review program.

Drugs and Biologics–Research, Development and Competition

These provisions seek to support the development of drugs and
biologics, including, among other things, measures to support
certain technological advancements and treatments for rare diseases
and conditions and measures relating to the accelerated approval

  • Section 3201. Prompt reports of marketing status by
    holders of approved applications for biological products
    Requires holders of approved biologics license applications (BLA)
    to report to FDA when withdrawing a product from the market. Also
    requires BLA holders to submit, within 180 days of enactment of
    FDORA, a one-time report to confirm that their products in the
    Purple Book that are not listed as discontinued are still available
    for sale. Also requires FDA to update the Purple Book to remove
    biological products that are no longer on the market.

  • Section 3202. Improving the treatment of rare diseases
    and conditions
    . Requires the FDA to deliver a report on
    its Orphan Drug Program to Congress by September 30, 2026. Also
    requires FDA to finalize the draft guidance “Rare Diseases:
    Common Issues in Drug Development.” Also requires the
    Secretary to enter into a contract with the National Academies of
    Sciences, Engineering and Medicine to study how the safety and
    efficacy of drugs for rare diseases is evaluated in the United
    States and European Union. Also requires FDA to host a least one
    public meeting to gather input from stakeholders and requires GAO
    to study FDA’s activities relating to the development and
    review of drugs for rare diseases.

  • Section 3203. Emerging technology program.
    Enables FDA to create the Emerging Technology Program “to
    support the adoption of, and improve the development of, innovative
    approaches to drug design and manufacturing.” Also requires
    FDA to issue related guidance and submit a report to Congress
    regarding the allocation of funds and the use of staff for this

  • Section 3204. National Centers of Excellence in
    Advanced and Continuous Pharmaceutical Manufacturing
    Authorizes FDA to designate institutions of higher education as
    National Centers of Excellence in Advanced and Continuous
    Pharmaceutical Manufacturing and award grants to such designated

  • Section 3205. Public workshop on cell
    . Requires FDA to hold a public workshop within
    three years of the date of the bill’s enactment “to
    discuss best practices on generating scientific data necessary to
    further facilitate the development of certain human cell-, tissue-,
    and cellular-based medical products (and the latest scientific
    formation about such products).”

  • Section 3206. Clarifications to exclusivity provisions
    for first interchangeable biosimilar biological products
    Allows multiple interchangeable biological products to share a
    period of first interchangeable exclusivity if they are approved on
    the same day.

  • Section 3207. GAO report on nonprofit pharmaceutical
    . Requires GAO to submit a report on
    nonprofit pharmaceutical manufacturing organizations to Congress
    within two years of the enactment of the bill.

  • Section 3208. Rare disease endpoint advancement pilot
    . Requires FDA to create a pilot program to
    “increase[] interaction with sponsors of rare disease drug
    development programs for purposes of advancing the development of
    efficacy endpoints . . . for drugs intended to treat rare
    diseases.” Also requires FDA to submit a report to Congress on
    this pilot program and to issue guidance on best practices for
    development of efficacy endpoints for rare diseases.

  • Section 3209. Animal testing alternatives.
    Specifies that drug application sponsors can use pre-clinical tests
    that are not tests on animals to demonstrate safety and
    effectiveness of their drug. Also specifies that sponsors of
    biosimilar applications can assess toxicity of their biosimilar
    product using tests that are not tests on animals.

  • Section 3210. Modernizing accelerated

  • Requires FDA to specify the conditions for required
    post-approval studies for products approved under accelerated
    approval. Also permits FDA to require post-approval studies to be
    underway prior to approval or within a specified time period after
    approval. Also requires FDA to publish an explanation when it does
    not require a sponsor to conduct a post-approval study.

  • Specifies the procedures FDA must follow to withdraw a
    product’s accelerated approval on an expedited basis, which
    include: (1) providing the sponsor with due notice, an explanation
    for the proposed withdrawal, and an opportunity to meet with the
    Commissioner or the Commissioner’s designee; (2) providing an
    opportunity for public comment; (3) responding to such comments;
    and (4) convening an advisory committee relating to the proposed
    withdrawal if the sponsor requests one and no such advisory
    committee has previously advised FDA on the proposed

  • Requires reports on post-approval study progress to be made no
    later than 180 days after approval and every 180 days thereafter
    until any required post-approval studies are completed.

  • Makes failure to conduct required post-approval studies with
    due diligence and failure to submit the required reports prohibited
    acts, which can result in a criminal prosecution.

  • Requires FDA to issue guidance on: (1) “how sponsor
    questions related to the identification of novel surrogate or
    intermediate clinical endpoints may be addressed in early stage
    development meetings with [FDA];” (2) the use of novel
    clinical trial designs to conduct post-approval studies; (3) the
    expedited withdrawal procedures; and (4) “considerations
    related to the use of surrogate or intermediate endpoints that may
    support the accelerated approval of an application . . . ,
    including considerations in evaluating evidence related to any such
    endpoints.” Also requires FDA, within 1 year of the bill’s
    enactment, to create an intra-agency coordinating council within
    the FDA to ensure FDA appropriately uses the accelerated approval

  • Section 3211. Antifungal research and
    . Requires FDA to issue guidance to assist
    entities seeking approval or licensure of antifungal therapies
    meant to treat coccidioidomycosis, also known as Valley Fever. Also
    requires FDA to hold a public workshop to assist entities
    developing vaccines for Valley Fever and other fungal

  • Section 3212. Advancing qualified infectious disease
    product innovation
    . Revises Section 505E of the Food,
    Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355f) (also known
    as the GAIN Act) to include biological products in the definition
    of “qualified infectious disease product.”

  • Section 3213. Advanced manufacturing technologies
    designation program
    . Requires FDA to develop a process for
    designating methods of manufacturing drugs, including biological
    products, and active ingredients of drugs, as advanced
    manufacturing technologies. “A method of manufacturing . . .
    is eligible for designation as an advanced manufacturing technology
    if such method . . . incorporates a novel technology in a novel
    way, that will substantially improve the manufacturing process for
    a drug while maintaining equivalent, or providing superior, drug
    quality.” Such designated technologies will receive an
    expedited review process. In relation to this designation program,
    this section also requires FDA to hold a public meeting to gather
    input from stakeholders, issue guidance and submit a report to

Drugs and Biologics–Transparency, Program Integrity and
Regulatory Improvements

These provisions contain several additional measures involving
drugs and biologics, including a measure to increase access to
affordable drugs.

  • Section 3221. Safer disposal of opioids.
    Revises Section 505-1(e)(4)(B) of the FD&C Act to eliminate the
    phrase “for purposes of rendering drugs non-retrievable (as
    defined in Section 1300.05 of title 21, Code of Federal Regulations
    (or any successor regulation)).” This change will give FDA
    greater flexibility when it “require[s] a risk evaluation
    mitigation strategy for a drug for which there is a serious risk of
    an adverse drug experience.” Previously, if FDA required such
    a drug “be dispensed to certain patients with a safe disposal
    packaging or safe disposal system,” the safe disposal
    packaging or safe disposal system had to be “for purposes of
    rendering drugs non-retrievable.”

  • Section 3222. Therapeutic equivalence
    . Requires FDA to make therapeutic equivalence
    determinations for 505(b)(2) new drug applications, if requested by
    the sponsor, either when the application for such a drug is
    approved or up to 180 days post-approval.

  • Section 3223. Public docket on proposed changes to
    third-party vendors
    . Requires FDA to open a public comment
    period regarding factors that FDA should consider “when
    reviewing requests from sponsors of drugs subject to risk
    evaluation and mitigation strategies [REMS] to change third-party
    vendors engaged by sponsors to aid in implementation and management
    of the strategies.”

  • Section 3224. Enhancing access to affordable
    . Allows FDA to approve a generic drug even if
    there are differences between its proposed labeling and that of the
    listed drug due to FDA approving a change to the listed drug’s
    label within 90 days of when the generic drug’s application is
    otherwise eligible for approval. However, if the change to the
    listed drug’s label involves the “warnings” section,
    this provision will not apply. Also requires the sponsor of the
    generic drug application to submit revised labeling for the generic
    drug within 60 days of approval.

Medical Devices

These provisions make several changes involving medical device
authorities, including measures to ensure cybersecurity of medical
devices and clarifications around FDA’s authority to ban
medical devices for one or more intended uses.

  • Section 3301. Dual submission for certain
    . Allows sponsors of certain diagnostic tests that
    were authorized for emergency use, when submitting a request for de
    novo classification under Section 513(f)(2) of the FD&C Act, to
    submit such request with sufficient information to enable FDA to
    determine whether such test meets the requirements for home

  • Section 3302. Medical Devices Advisory Committee
    . Requires the Medical Devices Advisory Committee
    to meet at least once a year until 2027 to provide advice to FDA
    relating to the use of medical devices in preparing for and
    responding to pandemics.

  • Section 3303. GAO report on third-party
    . Requires GAO to submit a report to Congress, by
    September 30, 2026, on the medical device 510(k) third-party review

  • Section 3304. Certificates to foreign
    . Specifies that FDA can issue Certificates to
    Foreign Governments for devices manufactured by a device
    establishment located outside of the United States as long as the
    establishment is registered, the device is listed, the device is
    lawfully sold in the United States, and the device is imported or
    offered for import into the United States.

  • Section 3305. Ensuring cybersecurity of medical
    . Requires manufacturers of “cyber
    devices,” when making a premarket submission to FDA, to
    provide a plan to monitor and address any post-market cybersecurity
    vulnerabilities; create and maintain procedures to ensure the
    device and related systems are cybersecure; provide a software bill
    of materials; and comply with any other requirements FDA may
    develop to ensure the device and related systems are cybersecure.
    Defines a “cyber device” as a device that “(1)
    includes software validated, installed or authorized by the sponsor
    as a device or in a device; (2) has the ability to connect to the
    internet; and (3) contains any such technological characteristics
    validated, installed or authorized by the sponsor that could be
    vulnerable to cybersecurity threats.” FDA may exempt certain
    devices from meeting this section’s requirements. This
    provision also makes a failure to comply with these requirements a
    prohibited act.

  • Section 3306. Bans of devices for one or more intended
    . Permits FDA to ban a device “for one or more
    intended uses” and specifies that “[a] device that is
    banned for one or more intended uses is not a legally marketed
    device under Section 1006 when intended for such use or uses.”
    This provision is a response to Judge Rotenberg Educ. Ctr.,
    Inc. v. FDA
    , which found that FDA could not ban a single
    intended use of a specific device because such a ban goes against
    Section 1006 of the FD&C Act, which prohibits FDA from
    regulating the practice of medicine.

  • Section 3307. Third party data transparency.
    Requires FDA to request access to data or other information that
    FDA seeks to rely upon when making regulatory decisions about
    devices and which comes from entities that FDA has funded in whole
    or in part or FDA has contracted with. Also requires FDA, to the
    extent practicable, to provide manufacturers with summaries of such

  • Section 3308. Predetermined change control plans for
    . Authorizes FDA to approve a predetermined change
    control plan submitted in a premarket approval application or a
    supplemental application “that describes planned changes that
    may be made to the device (and that would otherwise require a
    supplemental application . . .), if the device remains safe and
    effective without a change.” Also allows FDA to clear a
    predetermined change control plan submitted in a 510(k)
    notification if “the device remains safe and effective without
    any such change; and . . . the device would remain substantially
    equivalent to the predicate.” Also specifies that a sponsor
    cannot use “changed versions of a device implemented in
    accordance with an established predetermined change control plan as
    a predicate device.” Only the version of the device originally
    cleared or approved can be used by a sponsor as a predicate

  • Section 3309. Small business fee waiver.
    Permits businesses that reported $1 million or less of gross
    receipts or sales in its most recent federal income tax return for
    a taxable year to receive a waiver of the Medical Device User Fee
    Amendments annual establishment registration fee if FDA finds that
    paying the fee would be a financial hardship for the business.

Infant Formula

Section 3401 provides for several measures to
improve the safety and availability of infant formula. These
measures include a provision allowing FDA to substitute a 30-day
premarket submission requirement for the typical 90-day premarket
submission requirement for infant formula when there is a supply
shortage. The section also requires FDA to conduct annual
inspections of each infant formula manufacturer.


These provisions—the Modernization of Cosmetics Regulation
Act of 2022—make a number of changes intended to strengthen
FDA’s regulation of cosmetics. The law not only includes new
requirements for industry, but also provides FDA with additional
authority to inspect, evaluate and take enforcement action with
regard to cosmetic products.

  • Section 3502. Amendments to cosmetic
    . Amends Chapter VI of the FD&C Act by
    adding several new provisions for cosmetic products:

  • Section 604. Definitions. Defines
    “adverse event,” “cosmetic product,”
    “facility,” “responsible person,” and
    “serious adverse event.”

  • Section 605. Adverse events. Requires
    responsible person to submit to FDA reports of any serious adverse
    event involving the use of a cosmetic product within 15 business
    days of receipt of such a report. Allows FDA to request a list of
    ingredients or categories of ingredients in a fragrance or flavor
    if FDA “has reasonable grounds to believe that an ingredient
    or combination of ingredients in a fragrance or flavor has caused
    or contributed to a serious adverse event.”

  • Section 606. Good manufacturing practice.
    Requires FDA to issue regulations on cosmetic good manufacturing

  • Section 607. Registration and product listing.
    Requires persons that own or operate a facility that manufactures
    or processes cosmetic products for distribution in the United
    States to register each facility with the FDA. Also requires
    responsible persons to submit to FDA a product listing for each
    cosmetic product. Authorizes FDA to suspend the registration of a
    facility if FDA “determines that a cosmetic product . . . has
    a reasonable probability of causing serious adverse health
    consequences or death to humans and [FDA] has a reasonable belief
    that other products manufactured or processed by the facility may
    be similarly affected.”

  • Section 608. Safety substantiation. Requires
    responsible persons to ensure there is adequate substantiation
    regarding the safety of a cosmetic product. Also permits FDA to
    consider cumulative exposure when evaluating the safety of a
    cosmetic product.

  • Section 609. Labeling. Requires that the label
    for each cosmetic product contain contact information to facilitate
    the reporting of adverse events. Also requires any fragrance
    allergen in a cosmetic product to be included on the label. Also
    requires cosmetic products intended to be used only by a
    professional to bear a label that states that the product can only
    be administered or used by a licensed professional.

  • Section 610. Records. Authorizes FDA to access
    and copy records relating to a cosmetic product if FDA reasonably
    believes that the cosmetic product “is likely to be
    adulterated such that the use or exposure to such product presents
    a threat of serious adverse health consequences or death to

  • Section 611. Mandatory recall. Permits FDA to
    order a recall of a cosmetic product if FDA “determines that
    there is a reasonable probability” it is adulterated or
    misbranded and “the use or exposure to such cosmetic will
    cause serious adverse health consequences or death.”

  • Section 612. Small businesses. Exempts small
    businesses (those with average gross annual sales from the previous
    three years of less than $1 million) from the requirements of
    Section 606 and 607 unless the small business makes certain
    enumerated products.

  • Section 613. Exemptions for certain products and
    . Exempts cosmetic products and facilities that
    are also subject to the drug and medical device provisions of the
    FD&C Act from the above requirements except for certain
    labeling requirements.

  • Section 614. Preemption. Critically, the new
    law preempts any state or local law that differs from or adds to
    the requirements relating to registration and product listing, good
    manufacturing practice, records, recalls, adverse event reporting,
    or safety substantiation. This section also specifies that the Act
    only preempts those laws that are expressly preempted.

  • Section 3503. Enforcement and conforming
    . Authorizes FDA to take enforcement action
    beginning one year after the enactment of the Modernization of
    Cosmetics Regulation Act of 2022 for failure to register or submit
    listing information, refusal or failure to follow a recall order,
    and failure to comply with adverse event reporting requirements.
    Also specifies that a cosmetic product is adulterated if it has
    been manufactured or processed in such a way that does not meet the
    good manufacturing practice requirements or if its safety is not
    adequately substantiated. Also specifies that a cosmetic product is
    misbranded if it does not meet the labeling requirements described
    in Section 609.

  • Section 3504. Records inspection. Makes clear
    that when inspecting a facility that manufactures or processes a
    cosmetic product, FDA has the ability to inspect records and other
    information covered by Sections 605, 606 and 610 if the relevant
    standard for records inspection is met.

  • Section 3505. Talc-containing cosmetics.
    Requires FDA to issue regulations to develop standardized testing
    methods for detecting asbestos in talc-containing cosmetic

  • Section 3506. PFAS in cosmetics. Requires FDA
    to evaluate the use and safety of perfluoroalkyl and
    polyfluoroalkyl substances (PFAS) in cosmetic products.

  • Section 3507. Sense of the Congress on animal
    . States that “[i]t is the sense of the
    Congress that animal testing should not be used for the purposes of
    safety testing on cosmetic products and should be phased out with
    the exception of appropriate allowances.”

  • Section 3508. Funding. Authorizes
    appropriations relating to these cosmetic provisions.

Clinical Trial Diversity and Modernization

These provisions seek to improve clinical trials by, among other
things, increasing diversity and the use of digital health
technologies in clinical trials.

  • Section 3601. Diversity action plans for clinical
    . Requires sponsors of a “pivotal” study
    of a new drug or of an investigational device to submit a diversity action plan to FDA.

  • Section 3602. Guidance on diversity action plans for
    clinical studies
    . Requires FDA to issue or update guidance
    regarding the diversity action plans.

  • Section 3603. Public workshops to enhance clinical
    study diversity
    . Requires FDA to hold at least one public
    workshop to gather input from stakeholders regarding increasing
    diversity in clinical trials, among other topics. Also requires FDA
    to open a public comment period to receive comments on the topics
    discussed during each public workshop.

  • Section 3604. Annual summary report on progress to
    increase diversity in clinical studies
    . Requires FDA to
    submit to Congress, and publish on its website, within two years of
    the bill’s enactment and each year thereafter, a report on the
    diversity actions plans FDA receives.

  • Section 3605. Public meeting on clinical study
    flexibilities initiated in response to COVID-19 pandemic
    Requires FDA to hold a public meeting within 180 days of the end of
    the COVID-19 emergency period to discuss the recommendations FDA
    made during the COVID-19 emergency to reduce disruption to clinical

  • Section 3606. Decentralized clinical studies.
    Requires FDA to issue guidance on the use of decentralized clinical
    studies to facilitate the development of drugs and devices.

  • Section 3607. Modernizing clinical trials.
    Requires FDA to issue guidance on “the appropriate use of
    digital health technologies in clinical trials to help improve
    recruitment for, retention in, participation in, and data
    collection during, clinical trials” and “the use of
    seamless, concurrent and other innovative clinical trial designs to
    support the expedited development and review of applications for
    drugs, as appropriate.”


FDORA includes a number of changes that expand FDA’s
inspection authorities.

  • Section 3611. Device inspections. Authorizes
    FDA to request not only records, but other information either prior
    to or in lieu of an inspection of a facility that manufactures,
    prepares or processes medical devices. Requires FDA to issue
    guidance relating to such requests.

  • Section 3612. Bioresearch monitoring
    . Authorizes FDA to inspect not only records,
    but other information as well, when conducting bioresearch
    monitoring inspections. Requires FDA to issue guidance relating to
    bioresearch monitoring inspections.

  • Section 3613. Improving Food and Drug Administration
    . Requires FDA to consider “[t]he
    compliance history of establishments in the country or region in
    which the establishment is located” when determining a
    schedule for risk-based inspections. Authorizes FDA to use records
    or other information when conducting a preapproval or risk-based
    surveillance inspection. Permits FDA to enter into agreements with
    foreign governments to facilitate preapproval inspections.

  • Section 3614. GAO report on inspections of foreign
    establishments manufacturing drugs
    . Requires FDA to submit
    a report to Congress on inspections of foreign facilities conducted
    by FDA or on behalf of the FDA by foreign governments.

  • Section 3615. Unannounced foreign facility inspections
    pilot program
    . Requires FDA to develop a pilot program to
    increase unannounced surveillance inspections of foreign drug
    establishments and compare inspections of domestic and foreign drug

  • Section 3616. Enhancing coordination and transparency
    on inspections
    . Requires FDA to “ensure timely and
    effective coordination and alignment among the field investigators
    of [FDA] and the staff of the Center for Drug Evaluation and
    Research’s Office of Compliance and Drug Shortage

  • Section 3617. Enhancing transparency of drug facility
    inspection timelines
    . Requires FDA to release a yearly
    report on its inspections of facilities under subsection (c) or (j)
    of Section 505 of the FD&C Act, including information on
    various time aspects of such inspections.


  • Section 3621. Regulation of certain products as
    . Addressing the Genus decision in part, the law
    defines contrast agents, radioactive drugs and over-the-counter
    monograph drugs, as those terms are defined in the provision, as
    drugs and not devices. The provision also waives the application
    fee for products currently considered devices that will now be
    considered drugs under this section.

  • Section 3622. Women’s Health Research
    . Requires the Office of Women’s Health to
    review and, if needed, update the Women’s Health Research
    Roadmap and brief Congress on its review.

  • Section 3623. Strategic workforce plan and
    . Requires FDA to develop and publish a strategic
    workforce plan every four years.

  • Section 3624. Enhancing Food and Drug Administration
    hiring authority for scientific, technical and professional
    . Requires FDA to analyze how it has used its
    increased hiring authority under the 21st Century Cures Act and
    allows FDA to hire experts to support the regulation of not only
    medical products, but also food and cosmetics.

  • Section 3625. Facilities management. Clarifies
    rules regarding FDA’s spending of fees from the Prescription
    Drug User Fee Amendments, Generic Drug User Fee Amendments, Medical
    Device User Fee Amendments, and Biosimilar User Fee Amendments

  • Section 3626. User fee program transparency and
    . Requires FDA to release more information
    on the user fee programs and to make regular updates to Congress on
    the user fee negotiations.

  • Section 3627. Improving information technology systems
    of the Food and Drug Administration
    . Requires FDA, every
    four years, to develop a coordinated information technology
    strategic plan to modernize the information technology systems of

  • Section 3628. Reporting on mailroom and Office of the
    Executive Secretariat of the Food and Drug Administration
    Requires FDA to submit a report to Congress, within 90 days of the
    bill’s enactment, on FDA’s mailroom and requires subsequent
    yearly reports to Congress on new policies involving its receipt of

  • Section 3629. Facilitating the use of real world
    . Requires FDA to issue or revise guidance on
    “the use of real world data and real world evidence to support
    regulatory decision-making.”

  • Section 3630. Facilitating exchange of product
    information prior to approval
    . This provision essentially
    enshrines FDA’s Payor Communications Guidance in law, and
    allows drug and medical device sponsors to provide certain
    information on investigational products to payors, formulary
    committees and other similar entities.

  • Section 3631. Streamlining blood donor input.
    States that the Paperwork Reduction Act will not apply to the
    collection of voluntary information provided by blood donors or
    potential blood donors, at the request of FDA, to support the
    development of FDA’s recommendations relating to blood

* * *

It will be important for industry stakeholders to understand
FDORA’s changes to FDA’s authorities and mandates. Our team
will be closely monitoring agency implementation and further
Congressional action. Please feel free to contact us with any

* Katherine Schlusser contributed to this Advisory. Ms.
Schlusser is a graduate of The George Washington University School
of Law and is employed at Arnold & Porter’s Washington, DC
office. Ms. Schlusser is not admitted to the practice of law in
Washington, DC.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.


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