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December 30, 2022

U.S. FDA User Fee Riders Make It Across the Line: A Guide to the Food and Drug Omnibus Reform Act (FDORA)

Advisory

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, but also included a landmark expansion in FDA's authority over cosmetics.

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.1Allows 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.

© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. This adverse event reporting scheme is broad in nature and also requires the responsible person to submit to FDA “any new and material medical information, related to the serious adverse event report . . . that is received by the responsible person within 1 year of the initial report . . . no later than 15 business days after such information is received by such responsible person.