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
Program. - Section 2502. Third party test evaluation during
emergencies. 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
transparency. Permits FDA to release to the public more
safety and effectiveness information about products authorized for
emergency use. - Section 2505. Improving FDA guidance and
communication. 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
States. - Section 2512. Extending expiration dates for certain
drugs. 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
requests. - 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
shortages. 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
notifications.
Reauthorizations
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
Improvements
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
process.
- 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
program. - 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
institutions. - Section 3205. Public workshop on cell
therapies. 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
organizations. 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
program. 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
approval.
- 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
withdrawal. - 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
process.
- Section 3211. Antifungal research and
development. 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
infections. - 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
Congress.
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
evaluations. 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
medicines. 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
devices. 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
use. - Section 3302. Medical Devices Advisory Committee
meetings. 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
review. Requires GAO to submit a report to Congress, by
September 30, 2026, on the medical device 510(k) third-party review
program. - Section 3304. Certificates to foreign
governments. 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
devices. 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
uses. 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
information. - Section 3308. Predetermined change control plans for
devices. 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
device. - 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.
Cosmetics
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
requirements. 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
practices. - 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
humans.” - 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
facilities. 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
amendments. 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
products. - 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
testing. 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
studies. 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
studies. - 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.”
Inspections
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
inspections. 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
inspections. 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
establishments. - 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
Program.” - 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.
Miscellaneous
- Section 3621. Regulation of certain products as
drugs. 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
Roadmap. 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
report. 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
personnel. 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
programs. - Section 3626. User fee program transparency and
accountability. 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
FDA. - 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
mail. - Section 3629. Facilitating the use of real world
evidence. 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
donation.
* * *
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
questions.
* 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.
link