Jill Wechsler is ACT's Washington Correspondent

Jill Wechsler, ACT's Washington Correspondent

As part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for drugs and medical products, at home and abroad. While the current goal is to improve FDA’s capability for monitoring and curbing contamination issues involving foods, the agency also proposes significant changes in oversight and inspection programs for medicines and other regulated products. Some of the changes arise from FDA’s greater reliance on remote oversight activities during the global COVID-19 pandemic, which encouraged more cooperation with foreign inspection programs, and these are likely to continue as FDA seeks to better monitor overseas facilities in more timely and less costly ways.

A recent sign of these developments is a slight change in how the Center for Drug Evaluation and Research (CDER) selects drug manufacturing sites for inspections to ensure compliance with standards. CDER’s Office of Pharmaceutical Quality (OPQ) recently updated procedures for its risk-based site selection model to additionally include the compliance history of an establishment in the country or region where it is located. This information will be added to FDA’s existing list of risk factors for setting inspection priorities, which includes site operations, product characteristics, compliance history, past field alert reports, recalls, and other compliance issues.

The aim of the update, FDA explains, is to provide more clarity on risk factors associated with patient exposure and inherent product risk, as specified in legislation enacted by Congress in late 2022. The Food and Drug Omnibus Reform Act (FDORA) encourages continued agency focus on inspections for the most critical production sites overseas and at home. However, one outcome of this change could be additional oversight of facilities that have good compliance histories but are located in regions or countries that warrant more frequent inspections.

This relatively targeted change in criteria for FDA selection of drug manufacturing inspection sites is part of an ongoing restructuring of the agency’s Office of Regulatory Affairs (ORA) to better monitor food safety issues and to schedule field inspections more efficiently. The aim is to prevent delayed responses to serious food contamination issues, as occurred with the baby-formula plant contamination and recall occurrence in 2022, which created a national crisis in formula shortages. FDA Commissioner Robert Califf announced on June 28 a revised model for ORA to better align with a new unified Human Food Program and to coordinate and respond expeditiously to public health issues.

These changes have been in the works since January of this year, as part of a broader initiative to better monitor food safety issues and to reorganize FDA’s field work to reflect the priorities of program offices and Centers.

 The reorganization will shift certain compliance functions currently managed within ORA to compliance offices in FDA centers, a shift that aims to “streamline operations and expedite decision-making” so that the agency can determine more quickly what sites to inspect and what compliance actions to take. ORA will focus more on conducting investigations, inspections, and oversight of imports, still operating through offices for medical devices, human and animal drugs, biologics, and bioresearch monitoring inspections (BIMO)—all reporting to an associate commissioner for regulatory affairs. More details on the plan are expected this fall and ultimately will involve Congressional review and more formal rulemaking, as well as agreement from FDA unions and staff. It remains to be seen whether these changes lead to more aligned and efficient oversight activities or uncertainty and duplication of effort.

Risk-based approach for clinical research monitoring

FDA’s emphasis on considering risk factors in planning for medical product oversight also applies to BIMO investigations. The agency issued a guidance in April that makes recommendations to industry on implementing a risk-based approach to monitor investigational studies on human drugs, biologics, medical devices, and combination products.

 This expands on a 2013 guidance on this subject, here providing additional recommendations for sponsors in planning and developing research monitoring plans and assessing results from such activities.

The guidance responds to a provision in FDORA that clarifies FDA’s authority to conduct BIMO inspections and which sites and facilities are subject to this oversight and required to provide records and other information. The guidance emphasizes the importance of data integrity in clinical trial monitoring and the need to design research protocols that identify potential risks for data collections. Centralized monitoring, moreover, should be applied across multiple clinical sites so that sponsors may detect inconsistencies or omissions in data and determine which clinical sites need further review.

Meanwhile, members of Congressional continue to complain that FDA is moving too slowly to revitalize foreign plant inspections, particularly for manufacturers of active ingredients and generic drugs in China and India found to violate FDA safety and quality regulations. A recent letter to FDA from leaders of the House Energy and Commerce Committee criticizes the agency’s decision to allow the temporary import of unapproved drugs from China, even though the purpose is to address a serious drug shortage. The legislators urge the agency to ramp up on-site inspections in those regions, instead of utilizing alternative oversight methods such as record reviews and remote site visits.

The broader aim of the July 18 letter is to urge more FDA action to reduce ongoing shortages of critical drugs, many with ingredients or generic products made abroad.

 FDA halted almost all foreign inspections during the pandemic, and only restarted those efforts earlier this year. Lawmakers have pressured FDA to end preannounced foreign site visits, a change that is difficult when resources and schedules are limited and offer little flexibility.

FDORA addresses this and a number of issues related to FDA foreign inspections. The legislation encourages more unannounced FDA inspections of foreign drug establishments, shifting away from FDA’s usual practice of scheduling foreign site visits in advance to ensure access to the facility. At the same time, FDORA aims to reduce unneeded foreign site visits by supporting expanded FDA use of mutual recognition agreements (MRAs) with trusted foreign regulatory counterparts to obtain reports and information related to pre-approval inspections, as well as more routine manufacturing site visits. The legislation supports FDA recognition of inspections by foreign regulatory counterparts, such as the European Union, the UK, Switzerland, and other established agencies, in an ongoing effort to minimize duplicative site visits by all parties.

https://www.fda.gov/media/116004/download?utm_medium=email&utm_source=govdelivery

https://www.fda.gov/news-events/press-announcements/fda-provides-update-proposal-unified-human-foods-program-including-new-model-office-regulatory

https://www.fda.gov/news-events/press-announcements/fda-provides-update-proposed-human-foods-program-and-office-regulatory-affairs-restructuring

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-based-approach-monitoring-clinical-investigations-questions-and-answers

https://d1dth6e84htgma.cloudfront.net/Letter_to_FDA_on_Foriegn_Drug_Inspections_dc7bf60a6d.pdf

https://energycommerce.house.gov/posts/e-and-c-republicans-press-fda-over-inadequate-inspection-of-drug-manufacturing-in-india-and-china

Articles

The agency proposes significant revisions to oversight programs for drugs and medical products. 

FDA Inspections Face Overhaul

 late last week of Eisai and Biogen’s new Alzheimer’s disease treatment, Leqembi, converted an earlier conditional approval status with further data from a multi-regional study of nearly 1,800 patients. Results indicated that the drug slows the rate of cognitive and functional decline in early Alzheimer’s patients, compared to placebo, but also raised certain safety concerns. The decision paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition.

Eisai and Biogen had gained FDA accelerated approval for Leqembi in January based on evidence from a Phase II study. However, reimbursement was limited by the earlier decision of the Centers of Medicare and Medicaid Services (CMS) to pay for Alzheimer’s drugs only for those patients enrolled in clinical trials to further test the safety and efficacy of the therapy. This approach utilized CMS’ Coverage with Evidence Development (CED) policy, which limits access to certain innovative medical products while clinical trials continue and is most commonly used for new medical devices. It was very unusual and controversial for CMS to curb coverage for a drug granted accelerated approval by FDA, and reflects concerns about potentially huge outlays for Medicare on a therapy that may have limited efficacy and potential adverse effects.

Now with the sponsor presenting trial data supporting full FDA approval, CMS said it will provide appropriate, broader coverage for Leqembi. But reimbursement still will be contingent on physicians enrolling patients in registries so that CMS may track the effectiveness of the treatment and emergence of side effects going forward with broader patient use.

Eisai set the stage for FDA full approval by conducting a large Phase III placebo-controlled, double-blind, randomized study in North America, Europe, and Asia. Study 301 Clarity AD enrolled 1,795 patients with early Alzheimer’s disease, as seen in measures of mild cognitive impairment or mild dementia stage disease. Half of the participants received treatment and half placebo, with further stratification based on severity of disease, use of other medications, geographical region, and evidence of relevant genetic markers.

FDA approval of Leqembi was based on data from 18 months of treatment indicating that the drug may slow progression of Alzheimer’s symptoms, as measured on global cognitive and functional scales.

 on June 9 that study results verified clinical benefit of Leqembi for its indicated use. However, the treatment will carry a boxed warning alerting patients and prescribers to the potential risks for individuals experiencing ARIA (amyloid-related imaging abnormalities) that may be associated with headaches, dizziness, as well as more serious brain edema. FDA recommends testing for a certain genetic marker that may be related to this condition.

Use and prescribing of the drug are uncertain, as many questions remain to be addressed concerning long-term effectiveness and prevalence and severity of side effects. And while Medicare and insurers will pay for much of the proposed $26,000 a year drug cost, patients will be responsible for considerable cost-sharing for the therapy, as well as a range of clinical visits and tests. At the same time, the relatively small positive effect on patient health may deter prescribing until additional data emerges. Utilization also may rise in the future with the development of new formulations that don’t require such frequent infusion, and more advanced diagnostics may better identify patients most likely to benefit and less likely to suffer serious side effects from the drug.

Washington Correspondent and can be reached at

https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval

https://www.cms.gov/files/document/fact-sheet-june-2023.pdf

https://www.eisai.com/news/2022/news202285.html

https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

The confirmatory study—which tracked 18 months of data—helped clear the way for new Alzheimer’s drug. 

Large Clinical Trial Supported Leqembi's Full Approval

Confusion recently arose over whether and how Medicare will cover new Alzheimer’s treatments, but the fine print indicates that reimbursement for such medicines still will occur only with the completion of studies to support full FDA approval. And even with that imprimatur from FDA, the Centers for Medicare and Medicaid Services (CMS) will limit reimbursement to patients who enroll in physicians’ registries. While one treatment for this widespread condition may gain full approval next month, accelerated approval status remains insufficient to support reimbursement by the feds.

The issue made headlines when CMS announced last week that Medicare will cover drugs in this new class of Alzheimer’s treatment that receive “traditional approval” from FDA.

 However, the fine print stipulated that coverage will only apply to those who participate in a registry to collect real-world data that can further assess the usefulness of these drugs for elderly patients. CMS ignited controversy last year when it decided to only pay for treatment of those few patients participating in confirmatory studies, under its coverage-with-evidence-development program.

The first drug likely to qualify for full approval is Leqembi from Eisai, which is scheduled for an FDA advisory committee review of its confirmatory studies on Friday.

 FDA granted accelerated approval for the treatment in January, but CMS limited coverage to those patients enrolled in confirmatory trials, as it did earlier with Biogen’s Aduhelm. In addition, Eli Lilly hopes to provide sufficient data to gain full approval for its Alzheimer’s therapy by year-end.

The Alzheimer’s Association protested CMS’ requirement for registry enrollment as erecting “an unnecessary barrier” to coverage. While patient registries are “important tools for gathering much needed real-world evidence” to improve patient care, they should not be used to limit access to an FDA-approved treatment, the patient advocates stated.

Similarly, the Biotechnology Innovation Organization (BIO) described CMS’ policy as reinforcing criticism of FDA accelerated approval and raised concerns that these challenges to accelerated approval will limit patient access to treatment and curb future innovation. Some members of Congress and patient groups agree with FDA on the importance of permitting broad access to potentially beneficial treatments, especially for severe conditions affecting small patient populations.

It really all comes down to money: the high cost of new Alzheimer’s treatments and potentially millions of patients likely to seek treatment would run up Medicare prescription drug budget exponentially.

https://www.cms.gov/newsroom/press-releases/cms-announces-plan-ensure-availability-new-alzheimers-drugs

https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-9-2023-meeting-peripheral-and-central-nervous-system-drugs-advisory-committee-meeting

https://www.alz.org/news/2023/cms-requires-registry-fda-alzheimers-treatments

Indicates that reimbursement for new slate of Alzheimer’s treatments will occur only with the completion of studies to support full approval.

Medicare Still Won’t Pay for Alzheimer’s Drugs Without Confirmatory Data

Recent challenges to certain controversial approval decisions has prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change. With more than 50 panels composed of academics, scientists, and various interested parties, the program has become overly complex and sometimes contentious, with some up-or-down votes on important approval decisions appearing at odds with ultimate decisions by agency reviewers.

Commissioner Robert Califf has been calling for changes to improve the operations and composition of its advisory panels for several months. In a keynote speech on May 17, at the annual meeting of the Food and Drug Law Institute (FDLI) in Washington, DC, Califf emphasized the need for the agency to strengthen committee structure and methods to be “more efficient, flexible, and effective in the exercise of our regulatory responsibilities.”

 He noted the value of interchange among FDA experts and those outside the agency, particularly on complex scientific issues, and that transparent discussion is important. But he also said that the advisory committee system “can be improved” to enable FDA scientists to “get the best advice possible.”

Similarly, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), cited plans at the FDLI meeting for advisory committee “modernization” among numerous key initiatives for her office in the coming months. The process will include efforts to refine the selection of advisors so that their “expertise applies precisely to the matters under consideration.” That may involve adding to advisory panels more temporary members with special knowledge about the drug or disease under discussion and taking steps to ensure diversity in geographic areas represented.

Cavazzoni also noted the need for FDA to improve how it communicates about advisory committee operations and their relationship to the agency. This involves emphasizing to the public that these panels play an advisory role to the agency—and that FDA retains ultimate decision-making authority.

FDA’s interest in updating advisory committee composition and operations has become more visible in recent months, stemming from the uproar that resulted when FDA granted accelerated approval in 2021 to Biogen’s Alzheimer’s treatment, Aducanumab, despite a near-unanimous vote against approval at an advisory meeting in November 2020. Three panel members resigned in protest, and Medicare limited coverage to those patients participating in ongoing clinical trials.

That controversy, and subsequent heated debates over the approval of other treatments for critical diseases with questionable efficacy data, has prompted FDA officials to reconsider the advisory committee process, including the composition of the panels and the issues identified for discussion. A main change would be to shift away from “gladiator votes”—yes-or-no decisions on specific applications—and to provide more nuanced opinions on the main issues. But in some cases, the absence of up-or-down votes on key questions may generate confusion as to what the committee experts actually recommend. In the recent consideration of Sarepta’s new gene therapy to treat Duchenne’s muscular dystrophy, the advisory committee supported approval by a very slim margin. However, the patient advocate on the panel made a strong case for FDA to approve the drug as another treatment option for this devastating condition. FDA staff has gone back to the drawing boards, indicating it may limit treatment to a very young age group pending further clinical results.

Interchange among outside experts on scientific and technologic questions is important, Califf emphasized at the FDLI meeting. Such debate “makes our decisions better,” he noted, and “adds a level of transparency.” However, the commissioner also raised concerns about the steady stream of “misinformation and disinformation” in society that can undermine public confidence in science and “weaken faith in governmental and other institutions, including the FDA.”

Public debate among expert advisors can both support sometimes controversial decisions by FDA staffers, but also raise challenges to agency actions. The advisory committee process is one element in this ongoing debate that appears open to improvement, and Califf advised the regulatory community to “stay tuned for developments in this area.”

https://www.fda.gov/news-events/speeches-fda-officials/remarks-commissioner-robert-califf-2023-food-and-drug-law-institute-fdli-annual-conference-05172023

Agency hopes to update and improve its advisory committee composition and operations—to help FDA scientists “get the best advice possible.”

FDA Eyes Advisory Committee Reform to Enhance Credibility

The continued surge in applications to FDA for testing new cellular and gene therapies (CGTs) is taxing the agency’s resources and highlighting the need for new policies and updated operations to fully realize the promise of these advanced treatments. FDA recently authorized accelerated approval for a new amyotrophic lateral sclerosis (ALS) drug, Biogen’s Qalsody (tofersen), based on years of testing to demonstrate the therapy’s potential for blocking production of a protein believed to give rise to ALS in some 500 of about 30,000 ALS patients with a specific gene mutation.

 Meanwhile, bluebird bio is seeking approval of a new treatment for a certain form of sickle cell disease (SCD), a lovo-cel gene therapy that is injected into the patient’s blood to produce anti-sickling hemoglobin.

To further such advances, officials in the Center for Biologics Evaluation and Research (CBER) seek added resources and new approaches for quickly bringing innovative therapies to patients. In numerous presentations in recent months, CBER Director Peter Marks has lamented the slow pace and high cost of developing and testing new gene therapies. FDA has approved about a dozen of these treatments so far, he pointed out in a webinar last month sponsored by the Alliance for a Stronger FDA.

 But after two decades of effort in this area, he urged changes to approve more than a handful of new products each year. “I don’t think we have a really long time to play around,” Marks commented, but need to “transform the environment” for developing these treatments through accelerated endpoints and regulatory flexibility.

One recent change is the formation of a new “super” Office of Therapeutic Products (OTP) in CBER to replace the smaller Office of Tissues and Advanced Therapies (OTAT). OTP has six offices overseeing 14 divisions and 33 branches, designed to house an expanded staff able to quickly assess new research programs and steer promising therapies through the regulatory process. The latest version of the user fee program for drugs and biologics provides added funding to support an increase in experts assigned to gene therapies, advanced manufacturing technologies, and related programs.

Marks also has proposed that CBER adopt some of the innovations established by FDA’s Oncology Center of Excellence (OCE), including FDA’s accelerated approval pathway for promising therapies. While acknowledging that not all fast approvals will confirm benefits later, he is optimistic that this approach can provide many seriously ill patients with access to important treatments faster than otherwise. A related plan is to launch a new version of Operation Warp Speed for rare diseases to support the development of gene therapies for conditions affecting small patient populations, starting with a few high-need programs that could benefit from more constant contact with FDA.

In addition, CBER is working to advance international cooperation among regulatory authorities in vetting and regulating new gene therapy applications to expand the global pool of patients testing and receiving treatment. This involves applying elements of OCE’s Project Orbis program to provide a framework for regulators to cooperate in reviewing concurrent submissions for biotech products outside the oncology area.

The high cost of producing GTs for small patient populations, however, presents the highest hurdle for CBER and manufacturers to bring more innovative gene therapies to patients. While FDA doesn’t consider cost in assessing the safety and efficacy of a medicine for market approval, Marks has voiced concerns about the long timeframe and expensive methods for producing treatments for only 30 to 40 patients a year—a process that he recognizes is very different from manufacturing monoclonal antibodies for thousands of people. Some gene therapies make it through clinical development, he noted, only to be dropped by sponsors due to high production costs that make these new treatments “commercially non-viable” and put clinical trial sponsorship out of reach of small companies and nonprofit disease organizations and foundations.

A priority for Marks is to reduce the bottlenecks in GT production processes and to provide added assistance to sponsors struggling with manufacturing issues. The expanded OTP has three chemistry, manufacturing, and controls (CMC) offices—for gene therapy, cell therapy and human tissue, and for plasma protein therapeutics—to accommodate more staffers with expertise in biotech manufacturing able to provide timely, accurate information in the this area.

CBER also has scheduled virtual “town hall” meetings for OTP staffers to clarify expectations on specific technical components required for investigational and market applications for CGTs. At presentations in September 2022 and in April, reviewers from OTP’s Office of Gene Therapy CMC addressed questions on guidance documents, assay qualification and validation, product characterization and release testing, and stability studies at different stages of product development and use.

 Another session on June 8 will focus on CMC for cellular and tissue products.

Marks sees a two-to-three-year window to move forward and transform the environment and manufacturing process for CGTs. Under current methods, these new products will continue to raise challenges in the cost and pricing arena, as seen in Biogen’s price tag for its new ALS drug of almost $200,000 a year for treatment. “If we get it right,” says Marks, FDA will realize some of its goals for advancing gene therapies, which will make a “huge difference in the bio-economy,” while also impacting patients’ lives.

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-amyotrophic-lateral-sclerosis-associated-mutation-sod1-gene

https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-submits-biologics-license-application-bla-fda-0

https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:75ca49a1-420f-4cc4-800a-8cace64e1d51?viewer%21megaVerb=group-discover

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/establishment-office-therapeutic-products

https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-gene-therapy-chemistry-manufacturing-and-controls-april-2023-04252023

https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/otp-town-hall-cell-therapy-chemistry-manufacturing-and-controls-june-2023-06082023

Agency seeks added resources and new approaches to accelerate more of these promising treatments to the market.

FDA Eyes New Strategies to Spur Gene Therapy Development

While it is important for the nation’s healthcare system and for biomedical research that the Supreme Court’s ruling late last week preserved access to mifepristone (Mifeprex) for now, the emergency action fails to ensure FDA’s long-standing regulatory authority and legal status for evaluating and approving new drugs and medical products. In sending the case back to the Fifth Circuit Court of Appeals for further review, the high court’s April 21 action leaves open the prospect of further rulings that could undermine FDA’s approval process. States where abortion remains legal are stocking up on the pills, and biopharma companies are filing briefs to support FDA’s authority to regulate the development of safe and effective medicines.

The case arises from a ruling by Texas federal judge Matthew Kacsmaryk that supports a lawsuit from abortion opponents claiming that FDA’s approval of mifepristone ignored demonstrated safety concerns and relied on “unsound reasoning and studies” in the face of “significant political pressure” to increase access to chemical abortions. The lawsuit also states that FDA overstepped its authority in expanding access to mifepristone in 2016 and January 2023 by moderating distribution restrictions imposed by a Risk Evaluation and Mitigation Strategy (REMS).

The Justice Department, acting for FDA, and manufacturer Danco Laboratories appealed the Texas case to the Fifth Circuit Court of Appeals, which ruled more narrowly that mifepristone could remain on the market, but only under its more limited original prescribing and dispensing conditions in effect until 2016. That decision also threatened access to a recently approved generic alternative from GenBioPro, raising tricky questions about whether a generic drug can remain on the market under conditions that differ from the original brand.

Complicating the situation was a decision in another case from a federal judge in Washington state that mifepristone is safe and effective and that FDA must maintain access to the drug in the 17 states and the District of Columbia backing the lawsuit. Here the court ruled that FDA erred in imposing REMS limits on prescribing and dispensing of the treatment and ordered federal authorities not to make any changes to restrict access to the drug.

In response to the circuit court ruling on the Texas case, the Biden administration and Danco filed an emergency appeal with the Supreme Court on April 14 to maintain approval of the drug while the case proceeds.

 The plaintiffs argued that FDA approval of the drug is based on studies demonstrating that mifepristone is safe and effective and that halting its distribution would harm patients. Multiple interested parties filed amicus briefs, including members of Congress, physicians, abortion rights groups, and opponents. Pharma and biotech companies railed against this “unprecedented assault on FDA’s approval decisions.”

In a declaration accompanying the FDA appeal to the Supreme Court, Deputy Commissioner Janet Woodcock attested to the harm and difficulties that would arise from a court decision that rescinds the conditions of use for mifepristone approved by the agency in 2016. Such a move would “create significant chaos” for FDA and manufacturers, Woodcock stated, emphasizing that it was a mistake to think that the agency “could simply snap back” to a prior approval situation. Manufacturers would need to revise product labeling, prescribing information, and other documents to reflect new dosing, which now would be out of date.

Here, Justice Samuel Alito disagrees, arguing in a four-page dissent that the high court should have left in place the pre-2016 restrictions on access to mifepristone as ordered by the appeals court.

 Alito claims that it would not cause “irreparable harm,” as FDA predicts, to limit the drug’s distribution to rules adopted in 2000 because, as he remarkably says, the agency could use its “enforcement discretion” to permit continued marketing of the drug even with outdated labeling while the legal appeals proceeded.

The broader issue for industry, policymakers and legal experts is whether FDA approval and marketing decisions can be overturned by private lawsuits on the basis of alleged safety issues that surface post-approval. If such a ruling is successful, it could open the drug regulatory process to allegations of violative behavior on all sides—faulty preclinical and clinical studies, newly detected side effects, and errors in FDA decisions. In the past, courts have shied away from making such rulings based on their recognition that the technical and scientific aspects of drug regulation are complex and need to be decided by experts.

The Fifth Circuit Court has scheduled an expedited hearing on the case for May 17 to review the merits of the Texas district court decision, particularly online and mail-order access to the drug. Many legal experts say the case should be tossed because the antiabortion doctors challenging FDA’s approval of mifepristone lack standing to bring the case. But whoever loses will appeal to the high court, where the outcome remains uncertain.

https://agportal-s3bucket.s3.amazonaws.com/uploadedfiles/Another/News/Press_Releases/Mifepristone%20Complaint.pdf

https://www.supremecourt.gov/DocketPDF/22/22A902/263491/20230414103258942_Alliance%20for%20Hippocratic%20Med%20%20application.pdf

https://www.bio.org/sites/default/files/2023-04/2023-04-11-amicus-brief.pdf

https://www.supremecourt.gov/opinions/22pdf/22a901_3d9g.pdf

The Supreme Court’s emergency action maintaining access to mifepristone fails to protect agency from future rulings that could subvert drug approval process.