Because No One is Immune to the Law
February 08, 2023 - FDA, Pharma, Medical Devices + Diagnostics, Rare Disease, United States

FDORA Passage Brings Significant Changes to FDA’s Drug, Device, and Cosmetic Authorities

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The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA).  FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical devices, and clinical trials, as well as cosmetics and other personal care products.  FDORA enacts many of the amendments to the FDCA that were previously drafted and negotiated as part of Congress’s reauthorization of the U.S. Food and Drug Administration’s (FDA) user fee programs.  Some key provisions of FDORA are summarized below.

Generally Applicable Reforms

  • Clinical Trial Diversity – Several FDORA provisions are aimed at addressing the need for racial, ethnic, gender, and social diversity in human clinical research.  Previously, while FDA had encouraged and sometimes requested that sponsors enroll more diverse patient populations in late-stage clinical trials of FDA-regulated products, it did not have the authority to mandate such measures.  FDORA requires sponsors to submit “diversity action plans” for phase 3 clinical trials or other pivotal studies for drugs and devices, unless otherwise waived or exempted.  The action plans must include the sponsors’ goals for enrollment, the underlying rationale, and an explanation of how the sponsor plans to achieve them.  FDA is tasked with issuing new guidance on diversity action plans and hosting at least one public workshop to solicit input from industry stakeholders on increasing diversity in enrollment and encouraging clinical study participation that reflects the prevalence of the disease among demographic subgroups.  The public workshop will take place sometime in 2023.
  • Real-World Data and Real-World Evidence (RWD/E) – FDORA requires FDA to issue guidance on considerations for the use of RWD/E to support regulatory decision-making for drugs and devices.  FDA must also conduct public workshops related to development of endpoints for rare diseases, which may include, “as appropriate, the use of [RWD/E] to support the validation of efficacy endpoints . . . for rare diseases.”
  • Pre-approval Communications with Payors – FDORA provides that both drug and device manufacturers are permitted to share certain information with payors, formulary committees, and similar entities regarding investigational products and investigational uses of approved products.  This amendment codifies FDA’s existing policy on pre-approval communications with payors that was detailed in its Guidance for Industry on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities (June 2018).

Drug Reforms

  • Accelerated Approval – FDA requested various updates to the language in the FDCA authorizing the agency to grant accelerated marketing approval to certain products for serious or life-threatening disease or conditions.  FDORA amends FDA’s accelerated approval process for drugs and biologics by:

    • Allowing FDA to require the sponsor to have confirmatory clinical trials underway before accelerated approval is awarded.

    • Requiring sponsors of products granted accelerated approval to submit progress reports for post-approval studies to FDA every six months.  Information from the progress reports must be publicly available on the FDA website.

    • Giving FDA the option to use expedited procedures to withdraw approval if the confirmatory trail fails to verify the product’s clinical benefit.

    • Requiring FDA to post the rationale for any decision not to require a post-approval study in connection with an accelerated approval.

    • Ordering the establishment of an intra-agency Accelerated Approval Council with senior official members from various FDA centers and divisions, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), to “ensure the consistent and appropriate use of accelerated approval” across the agency by engaging directly with product review teams which may include providing training and developing guidance.  The Council must meet at least three times a year and publish an annual report detailing its activities.

  • Bioresearch Monitoring (BIMO) Inspections – FDORA explicitly permits FDA inspection of facilities involved in the preparation, conduct, or analysis of clinical and non-clinical studies submitted to FDA, in addition to other persons holding study records or otherwise involved in the study process, such as contract research organizations and institutional review boards.  FDA must issue draft guidance on this additional inspection authority within 18 months of FDORA enactment.

  • Classification of Certain Products as Drugs – A provision in FDORA clarifies that any contrast agent, radioactive drug, or over-the-counter monograph drug is classified as a drug and not a device.  This provision was in direct response to Genus Medical Technologies, LLC v. FDA, 994 F.3d 631 (D.C. Cir. 2021), in which the court found that FDA lacked discretion to regulate a product meeting the statutory definition of a device as a drug.  Nonetheless, there may still be examples of other products that have been traditionally regulated as drugs but should be regulated as devices that are not included in these products that are deemed to be drugs.

Medical Device Reforms

  • Cybersecurity of Devices – FDORA imposes new premarket submission requirements for devices that meet the definition of a “cyber device” which must now include cybersecurity information, including a software bill of materials and plan to address cybersecurity vulnerabilities.  “Cyber devices” are defined as those that include software (including SAMD), have the ability to connect to the internet, and contain any such technological characteristics that could be vulnerable to cybersecurity threats.  FDA has the authority to identify devices or categories of devices that are exempt from the requirements.  FDORA also amends the list of prohibited acts in the FDCA to include failure to comply with these cybersecurity requirements.

  • Predetermined Change Control Plans – FDORA amends the FDCA to provide that predetermined change control plans may be approved in premarket applications and supplements or cleared under premarket notifications (510(k)).  If a predetermined change control plan is approved or cleared, then a change to a device that is consistent with such approved or cleared plan does not require submission of a supplemental PMA or new 510(k).

  • Device Bans for Specific Uses – FDORA expands FDA’s authority to ban medical devices under section 516 of the FDCA to allow FDA to ban specific intended uses.  This provision is enacted in response to the decision in Judge Rotenberg Educ. Ctr., Inc.v. FDA, 3 F.4th 390 (D.C. Cir. 2021), which held that FDA could not ban individual intended uses of an otherwise legally marketed device.

Cosmetic and Consumer Product Reforms

As detailed in a previous blog post, FDORA included the Modernization of Cosmetics Regulation Act (MoCRA), which strengthens FDA’s authority over the regulation of cosmetic products.  MoCRA introduces a comprehensive structure that implements regulatory requirements for responsible parties involved in the manufacture of cosmetic products, including facility registration, product and ingredient listing, serious adverse event reporting, compliance with product labeling requirements, and maintenance of records substantiating product safety.  MoCRA also tasks FDA with issuing regulations to establish good manufacturing practices for cosmetics and standardized testing methods for detecting asbestos in talc-containing cosmetic products.  In the prior blog post, the MoFo FDA + Healthcare Regulatory team discusses the specifics of the cosmetics regulation reforms and FDA’s expanded authority.

In addition to MoCRA, FDORA also included the INFORM (Integrity, Notification, and Fairness in Online Retail Marketplaces) Consumer Act in an effort to deter online sale of counterfeit goods.  Among other things, the INFORM Consumers Act requires online retail marketplaces that include third-party sellers of consumer products to verify the identity of “high-volume third-party sellers” by authenticating the seller’s government ID, tax ID, bank account information, and contact information.

Notable Omissions

While many of the policy riders left out of the user fee reauthorization legislation were included in FDORA, it is important to note that Congress did not reach agreement for some other key regulatory reform measures in time for inclusion as part of the omnibus bill.

VALID Act – The Verifying Accurate Leading-edge IVCT Development (VALID) Act would have rewritten FDA regulation of in vitro diagnostics (IVDs), redefining them as in vitro clinical tests (IVCTs), a new category of medical device products that includes both laboratory-developed tests (LDTs) and in vitro diagnostics.  The VALID Act would have conferred on FDA explicit statutory authority over LDTs for the first time and subjected this product category to requirements for registration and listing, premarket review and approval, adverse event reporting, and related processes for FDA oversight.

Product Listing for Dietary Supplements – The original Senate version of the user fee reauthorization bill also contained provisions establishing product listing requirements for dietary supplements that would require dietary supplement manufacturers, distributors, and packers to list product information with FDA.  The provisions would require FDA to provide unique listing numbers for each listed supplement and conduct facility inspections for high-risk facilities, suppliers, and dietary supplement types.