Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Jill Wechsler

While it may take weeks to know the final tally, neither Republicans nor Democrats are expected to have more than a slim majority in the House or Senate, which reduces the likelihood of highly partisan legislation in the months ahead. The economy and inflation were main concerns driving voters to the polls, but they did not generate the predicted ‘Red Wave’ to challenge Biden administration policies. At the same time, access to abortion was a prime issue, with voters supporting abortion rights ballot measures in five states. Even conservative voters opposed major reductions in health care, as seen in the vote in South Dakota to expand Medicaid coverage for low-income adults.

The situation makes it unlikely that Congress will tackle significant legislation during its lame duck session after Thanksgiving. Current members face a Dec. 16, 2022 deadline to approve an omnibus spending bill authorizing the federal government budget for 2023 to avoid a government shutdown. FDA would like the legislators to approve some of the measures dropped from the “slim” user fee reauthorization package approved in late September, but the calendar leaves little time for much debate. There’s a chance for approval of more targeted bills to revise FDA’s accelerated approval process, advance clinical trial diversity, clarify FDA inspection authority, and address cybersecurity in medical devices. But more complex measures to overhaul FDA regulation of 

 diagnostics, cosmetics, and dietary supplements are likely to remain on hold until the new Congress convenes in January.

In the House, a shift to Republican control is most likely, setting the stage for GOP-led committees that will hold hearings and issue reports challenging a range of health care issues. FDA officials are likely to be called to Capitol Hill more often to explain actions related to the shortage in infant formula, difficulties in reducing deaths from opioids, its proposal to ban menthol cigarettes, and modified rules for accessing health care through video conferencing.

The Senate Health, Education, Labor and Pensions (HELP) Committee is expected to have new leadership even if Democrats retain control. Chair Patty Murray of Washington may move to lead the powerful Senate Appropriations Committee, which leaves Bernie Sanders of Vermont as next in seniority. And with ranking Republican Richard Burr (R-N.C.) retiring, Sen. Rand Paul (R-Ky) is in line to head the panel. Sen. Paul already is taking about committee investigations into the Biden administration’s inadequate response to the COVID-19 pandemic, with Anthony Fauci a prime target.

Republican promises to lower taxes and reduce inflation by slimming down federal spending raise uncertainties about support for future pandemic planning, replenishing national stockpiles of drugs and vaccines, expanding research at the National Institutes of Health and strengthening state Medicaid programs. A main target for GOP leaders is the Inflation Reduction Act (IRA), a prime initiative for the Biden Administration that featured a provision reducing consumer outlays for prescription drugs. Although Republicans criticize many aspects of the legislation, they are unlikely to have the votes to kill drug price negotiation authority for Medicare. At the same time, Republican leadership makes further drug pricing legislation unlikely, including proposals to curb pharmaceutical launch prices.

At the same time, Republican leaders are expected to press for changes in FDA policies to make it difficult for women to access approved abortions pills and to gain access to over-the-counter contraception. A main issue is slated to be FDA’s authorization of telemedicine visits for prescribing abortion pills, instead of requiring women to visit the doctor’s office. It also remains to be seen to what extent abortion foes question the right of pregnant women to access approved therapies for cancer and other lethal conditions that also could jeopardize the health of a fetus.

Articles

The results of the mid-term election may reduce Congress’ ability to pass FDA-related legislation during its lame duck session. 

Major FDA Reform Unlikely in Closely Divided Congress

As expected, Congress reauthorized four key user fee programs at the last moment, as part of a must-pass measure to fund the federal government for another two months. The Continuing Resolution (CR) signed on Sept. 30, 2022 averted a federal government shutdown by extending the October 1, deadline for approving a federal spending plan for fiscal year 2023 to Dec. 16, 2022—after the mid-term elections in hopes that this will enable the legislators to reach a viable budget compromise.

This article was originally published online on October 5, 2022.

The CR reauthorizes fees for drugs (Prescription Drug User Fee Amendments [PDUFA]), generic drugs (Generic Drug User Fee Amendments [GDUFA]), biosimilars (Biosimilar User Fee Amendments [BsUFA]), and medical devices (Medical Device User Fee Amendments [MDUFA]) for the next five years, 2023–2028. In confirming FDA’s authority to collect fees from manufacturers, the agency avoids having to notify thousands of fee-supported staffers of looming layoffs. That prospect already had eroded agency morale and undermined efforts to recruit and hire needed staffers, as FDA struggled for months to maintain and expand its professional workforce during the added hardships imposed by the pandemic and in a very competitive labor market.

Medical product user fees generate some $2 billion in agency revenues, approximately 40% of FDA’s non-tobacco budget. While Congressional leaders on both sides of the aisle support this program to bolster key agency operations and innovations, the broader political debate over escalating government spending generated concerns about new fee-supported initiatives that extend the agency’s authority.

Even so, FDA officials, manufacturers, and research advocates gave a loud sigh of relief following the Congressional action. Commissioner Robert Califf praised the user fee reauthorization measure, while thanking agency staffers for their diligence in engaging in this “prolonged, demanding and, at times, frustrating process.” He noted that the bill avoids “a devastating impact” on FDA’s ability to carry out its “independent and transparent review of medical products.”

Califf added that FDA is committed to working with Congress to enact additional policy changes to benefit public health, but for now, is moving fast to implement multiple new fee-supported policies and programs. Similarly, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER), praised the
new fee programs for supporting CDER’s commitment to monitoring the safety of marketed products, protecting patients in clinical trials, and facilitating review of treatments for life-threatening diseases.

In an effort to make up for lost time in meeting tight deadlines for implementing new PDUFA-backed initiatives, FDA quickly posted a new webpage outlining criteria for manufacturers to participate in the new Split Real Time Application Review (STAR) program to accelerate patient access to critical therapies. The pilot aims to shorten the review time for efficacy supplements to approved drugs and biologics through earlier review of certain submissions before clinical study reports are final (1). FDA also provided information on a new Rare Disease Endpoint Advancement (RDEA) pilot to develop novel efficacy endpoints for critical treatments (2). Still to come are multiple new
policies described in the PDUFA VII commitment letter (3).

Enhancements in GDUFA III aim to reduce the number of assessment cycles for generics, support the development and approval of complex generics, and help manufacturers resolve quality issues more quickly. First off the line are new draft guidance documents on assigning review goal dates based on a manufacturing facility’s readiness for inspection (4) and on early assessment of APIs to speed application review (5). There’s new guidance on expediting development of “competitive” generic therapies and on policies for reviewing complex generic products (6). More information on GDUFA III is available on FDA’s website (7).

And for biosimilars, BsUFA III priorities involve expediting the review of certain supplements and launching a new regulatory science program to advance biosimilars and interchangeable products, already posted in a new FDA webpage outlining new pilots to improve the efficiency of biosimilar development and for interchangeable products (8). Further program revisions are listedin the BsUFA commitment letter (9).

The “skinny” user fee reauthorization dropped multiple high-profile proposals for revising how FDA regulates in vitro diagnostics, dietary supplements, and cosmetics, as well as the agency’s accelerated drug approval program and the regulation of artificial intelligence based medical devices. Advocates for developing critical new antibiotics back the PASTEUR Act to establish a new funding mechanism to support the development and proper utilization of drugs to fight resistant diseases. There is bi-partisan support for this “subscription” model for new cures, but its estimated cost of $11 billion over 10 years makes it a hard sell.

In past user fee reauthorization campaigns, a deadline to prevent fee expiration encouraged legislators to slip numerous pet proposals into this must-pass legislation. All parties recognized that this year would be much trickier, with a sharply divided Congress heading into mid-term elections and generally
unwilling to agree on much in the policy arena. This short-term
budget agreement avoids a government shutdown and funding crisis at FDA, but it dims prospects for enacting innovative, controversial or complex new measures.

Split Real Time Application Review (STAR),

 Development Resources, FDA.gov, accessed
Oct. 12, 2022.

Rare Disease Endpoint Advancement Pilot Program, Development Resources, FDA.gov,

PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027.

Facility Readiness: Goal Date Decisions Under GDUFA, Guidance for Industry, Draft Guidance

 Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA, Guidance for Industry, Draft Guidance

Competitive Generic Therapies, Guidance for Industry

FDA, Biosimilars–Science and Research, 

FDA, Biosimilar Biologic Product Reauthorization Performance
Goals and Procedures Fiscal Years 2023 Through 2027, 


Volume 46, Volume 11
November 2022
Pages: 14_15

When referring to this article, please cite it as J. Wechsler, “FDA User Fees Reauthorized,” 

FDA keeps its user fees but fails to gain important reforms.

FDA User Fees Reauthorized

State laws imposing strict curbs on surgical abortions have put FDA in the center of the debate on access to medicated abortion and morning-after pills and even to widely used contraceptives. A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of such treatments, as well as policies that could block prescriptions to medicines that treat a range of conditions that could affect maternal health and broader disease treatment.

A prime target of reformers is to limit patient access to the abortion pill, mifepristone, which is approved by FDA for use in the first 10 weeks of pregnancy, together with a second readily available pill misoprostol. Although the Justice Department has said it will take action against states that ban use of the medicine, the federal government may have limited authority to oppose such local actions. In addition, some analysts anticipate that abortion opponents will bring multiple legal challenges to FDA’s authority to approve medicated abortion pills, an issue likely to end up before the Supreme Court.

Meanwhile, FDA has raised alarms over the rise in rogue online pharmacies offering often bogus or dangerous “abortion pills.” Such operations have multiplied since the Supreme Court decision in June limiting abortion rights, which has sent demand for abortion medications soaring. Adding fuel to the fire is the move by some legitimate vendors and healthcare providers to give these pills to people before they become pregnant. Online telemedicine provider 

 and some physicians offer “advance provision” of mifepristone so that patients can be prepared to perform an abortion when needed. FDA, however, has objected to the practice, maintaining that a medical professional should be consulted to determine pregnancy status.

At the same time, FDA is under pressure from leading physicians and abortion advocates to remove all restrictions on how mifepristone is prescribed and used to make it more accessible to patients. FDA initially required that patients see a certified doctor to obtain the abortion pill as part of a Risk Evaluation and Mitigation Strategy (REMS) adopted for the treatment

During the pandemic, FDA temporarily permitted doctors to conduct examinations and prescribe mifepristone via telemedicine, a policy that is still in force but open to restoration of the earlier restriction. However, agency officials are wary that a move by FDA to make permanent its telemedicine consult policy is sure to draw protests from abortion opponents and could jeopardize further access to the pills, which have become more vital at a time of spreading curbs on abortions in any form.

Even though all patients are supposed to have no-cost access to birth control pills under the Affordable Care Act (ACA), some health plans and formularies have set co-pays and cost-sharing requirements for many products that threatens to limit availability of needed treatments. A report on 

Barriers to Birth Control issued in October 2022 

by the House Committee on Oversight and Reform cites widespread restrictions on multiple contraceptive products, based on data from leading health insurers and pharmacy benefit managers.

One response from women’s health advocates is for birth control pills to become available without prescription, and several manufacturers have expressed interest in developing such products. However, an anticipated approval has been delayed, as FDA recently postponed an advisory committee meeting scheduled for November to review a

 requested Rx-to-OTC switch for the progestin-only birth control pill Opill

 made by Perrigo subsidiary HRA Pharma. The HRA pill has been available by prescription since its approval in 1973, providing ample safety and efficacy data. FDA said it wanted to review additional information and left open when it would reschedule the committee discussion of what would be the first non-prescription daily birth control pill. Such a switch is sure to ignite disputes between advocates seeking easier and less costly access to birth control, and opponents claiming that a physician must review the health status of any woman seeking to use the pill.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA Embroiled in Reproductive Rights Debate

The long, convoluted FDA process to halt marketing of drugs that fail to confirm safety and efficacy in required postapproval confirmatory studies highlights the need to update and revise FDA’s now-controversial accelerated approval policy. This initiative has succeeded in speeding multiple important therapies to patients over the past 30 years. But the recent advisory committee vote to remove Makena from the market due to its failure to demonstrate benefits for patients illustrates how difficult it is for the regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Makena was approved more than 10 years ago as a treatment to lower the risk of preterm birth in patients considered at-risk for miscarriage, but a confirmatory trial failed to support earlier results. Even so, Makena marketer Covis Pharma has opposed removal, asserting that the drug remains vital for certain high-risk patients. However, FDA’s independent expert panel voted 14–1 in favor of FDA’s decision to halt sales of the therapy, setting the stage for the agency to proceed with its lengthy effort to remove from the market an expedited drug that fails to confirm benefit.

The debate over accelerated approval ignited in 2021 with FDA’s approval of Biogen’s Aduhelm to treat Alzheimer’s Disease. That decision generated a range of reform proposals to ensure that sponsors conduct required confirmatory studies and release results. FDA’s Oncologic Drugs Advisory Committee (ODAC) also highlighted the issue at meetings in April 2021 and September 2022 challenging “dangling approvals” for cancer therapies, which prompted some manufacturers to withdraw certain indications and others to renew confirmatory study efforts.

A September 2022 report from the Health and Human Services’ (HHS) Office of Inspector General (OIG) found that more than one-third of early approvals failed to meet timeframes for completing confirmatory studies, and that FDA’s difficulties in compelling withdrawals permit some therapies to stay on the market for years without verifying predicted clinical benefit, at considerable cost to insurers and Medicare and Medicaid. The 

approximately $700 million on Makena in recent years and said it was “crucial” to give FDA the tools to effectively administer the accelerated approval program.

Congressional leaders responded to FDA concerns by proposing legislation that requires sponsors to have confirmatory trials underway before gaining an early approval. Additional reforms aimed to facilitate FDA withdrawal of an approval if further study results fail to confirm efficacy within a certain period of time. These and other proposals initially were included in legislation to reauthorize FDA user fees but were dropped to meet tight deadlines for Congress to approve the funding measure. Efforts continue on Capitol Hill to include accelerated approval revisions in proposed legislation, but a tight Congressional calendar dims prospects for enacting regulatory reform measures.

Stricter oversight of the accelerated approval program appears likely, though, as drug costs and benefits remain in the spotlight. Medicare’s decision to limit coverage of Aduhelm has prompted health plans and insurers to scrutinize more closely the costs and utilization of therapies with conditional approval status. Although anxious to retain the accelerated approval program, the cancer community and numerous patient disease groups recognize that FDA should be able to remove those products where sponsors are unable or unwilling to confirm initial efficacy. The 

 at FDA’s Oncology Center of Excellence (OCE) aims to pressure sponsors to provide postapproval data in a timely manner and to withdraw products from the market when postapproval studies fail to confirm benefit or are not completed with due diligence.

Despite the lack of alternative treatment to Makena for women at risk of miscarriage, FDA is under pressure to halt marketing of the drug to maintain confidence in the accelerated approval program, which was established 30 years ago and is credited with facilitating access to more than 300 treatments for cancer and serious conditions. More recently, FDA has taken action to revoke approvals of some 35 drugs, most for specific indications. Leaving Makena on the market, even for limited use, is opposed as likely to encourage other sponsors to delay confirmatory studies and flout agency rules to maintain profitable sales.

In a recent speech to the National Organization for Rare Disorders (NORD), FDA Commissioner Robert Califf acknowledged the wide benefits of FDA’s accelerated approval program in generating therapies to treat serious rare diseases. He also urged fast action to reduce uncertainty about the true risks and benefits of those therapies approved based on biomarkers and limited clinical trials. More collaboration is needed, Califf said, to establish a “

system of evidence generation that provides the confirmation of benefits and risks over years

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Pressure Mounts for FDA to Reform Accelerated Approval Program

FDA’s Center for Biologics Evaluation and Research (CBER) is updating how it manages a growing volume of cellular and gene therapy development programs, seeking added resources and revisions in its oversight of these cutting-edge therapies. Most visible in the elevation of CBER’s Office of Tissues and Advanced Therapies (OTAT) into a new “super” Office of Therapeutic Products (OTP). The change aims to improve functional alignment, increase review capabilities, and add expertise on new cell and gene therapies by establishing multiple branches and divisions in the expanded regulatory unit, as announced in the 

Stated goals are to help CBER address the “substantial growth in innovative, novel products” that present new “scientific, medical and regulatory challenges that require changes to its structure,” including strategies to advance the Regenerative Medicine Advanced Therapy (RMAT) program. The added resources are needed to oversee more than 2000 development programs involving cellular and gene therapies, many involving innovative testing and manufacturing processes. This soaring workload has over-taxed CBER staffers, resulting in serious difficulties in retaining and hiring capable scientists.

The structural changes at CBER reflect agreed-on plans to hire new staffers with funding from recently reauthorized user fee programs. The PDUFA VII commitment letter calls for an additional 132 new hires for CBER in this coming year and another 48 employees the following year, most to support cell and gene therapy reviews at OTP. The reorganization plan calls for OTP to have seven offices—for therapeutic products, clinical evaluation, review management, pharmacology/toxicology, and two for CMC—for gene therapy and for cellular therapy and human tissues. There will be 14 divisions and 32 branches within those offices, providing attractive supervisory opportunities for both new and experienced staffers.

These changes come in the wake of FDA approval of two new gene therapies that have drawn wide attention for both their therapeutic potential and for million-dollar price tags. Bluebird bio’s Zynteglo was approved by FDA in August for patients with beta thalassemia, an inherited blood disorder causing serious anemia. That was followed a few weeks later with approval of Bluebird’s Skysona to treat a rare neurological disorder afflicting young boys. Zynteglo carries a $2.8 million price tag, Skysona’s list price is $4 million, but both therapies are expected to target fewer than 1500 patients, limiting the overall cost impact for the US healthcare system. A greater spending effect would come from FDA approval of a new treatment for sickle cell disease from Vertex Pharmaceuticals and CRISPR Therapeutics, which plan to begin a rolling review by FDA in the coming months. The important potential benefits of these treatments, along with concerns about their impact on healthcare spending and access, speaks to the need for a highly capable and sufficiently resourced FDA oversight program.

These developments also highlight the importance of sound testing and production methods for therapies made from living organisms, which are inherently variable and difficult to control and measure to assure product safety, identify, quality, purity, and strength. The surge in applications from a broad range of firms, moreover, has made it difficult for CBER staffers to schedule formal meetings with each sponsor seeking advice on how best to perform manufacturing and testing processes. And publishing new guidance on these changing and emerging issues also takes time and resources.

In response, FDA looks to engage a broad range of sponsors on topics related to product development through a series of virtual town hall meetings. The first was 

 and addressed how manufacturers should describe and inform FDA about chemistry, manufacturing, and controls (CMC) in applications for gene therapies. Wilson Bryan, OTAT (now OTP) director, opened the session by describing plans for establishing OTP as a super office to increase review capabilities and enhance expertise on gene and cellular therapies and set the stage for OTP branch chiefs to field a broad range of queries, ranging from basic CMC policies for various stages of development, to the scope of potency assays and impact of delivery devices on dose potency and quality [a recording of the town hall meeting is available at the FDA events link]. 

Main topics were comparability testing, assays for product characterization, and process controls. OTP staffers emphasized the importance of determining process requirements early in development to avoid late changes and analytical method variability that could raise uncertainties likely to delay clinical trials. Products with complex mechanisms of action, they advised, stand to benefit from early product characterization and potency assay development. And developers of gene therapies should use multiple production lots during a clinical study to ensure product consistency and quality, even for treatments for very small patient populations.

Manufacturers raised questions about differing CMC issues between early Phase I and late-stage clinical trials and voiced concerns about product characterization related to autologous cell-based gene therapies. A main theme from FDA was the importance of sponsors establishing a well-controlled manufacturing process and qualified analytical testing well before administering any new gene product. While CBER plans to issue guidance on manufacturing changes and comparability for cellular and gene therapy products, the information provided at this session provides unofficial guidance for implementing changes in product manufacturing and the scope of comparability assessments and development studies expected to support such changes.

CBER maps modernization plan to handle surge in research and applications. 

FDA Expands Oversight of Cell and Gene Therapies

Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expanding global drug production. While some initiatives predated the COVID-19 pandemic, the ongoing health emergency has elevated the importance of collaboration to speed biomedical research efforts and to ensure broad access to quality medicines and vaccines.

An important message from COVID-19 is the critical need for global regulatory convergence, commented Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), at the PDA–FDA Joint Regulatory Conference held on Sept. 12, 2022. He warned, though, that the move toward greater information sharing seen in recent years is “slipping away” as the pandemic recedes, speaking to the importance of joint efforts to provide pharmacovigilance information and review findings.

Such initiatives are not new for FDA, which has worked for decades to provide technical assistance to regulatory authorities in low- and middle-income countries to advance regulatory convergence and improve drug production methods. The Promoting Quality of Medicines Plus (PQM+) program implemented by the US Pharmacopeia with support from the US Agency for International Development (USAID) aims to build in-country regulatory capacity to ensure broad production of high-quality treatments for neglected tropical diseases, tuberculosis, and other infections. A FDA online seminar explained these issues for global regulators from lower-income regions, with agency experts describing the agency’s submission and regulatory processes and collaborative efforts to advance drug quality testing (1).

Pharmaceutical manufacturers in Europe and other industrial nations similarly are working to ensure equitable access to vaccines and treatments in future pandemics, as seen in a framework devised by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) to improve responses to future health emergencies. A declaration issued in July 2022 calls for the assessment and identification of successes in pathogen surveillance and vaccine development and distribution during the pandemic. The organization calls on biopharmaceutical companies to help regulators strengthen pandemic preparedness and response capabilities to accelerate the delivery of vaccines, treatments, and diagnostics in their regions (2).

Similarly, the International Coalition of Medicines Regulatory Authorities (ICMRA) aims to harmonize standards for collecting real-world evidence, for assessing manufacturing information, and for conducting inspections to support quality assessments. One program encourages collaborative assessment of chemistry, manufacturing, and control (CMC) data to facilitate post-approval changes and inspections in different regions (3).

FDA also supports global clinical testing and review efforts, such as Project Orbis at its Oncology Center of Excellence (OCE), which was launched in 2019 to advance cancer drug development and regulation. Under the program, sponsors submit applications for high-impact oncology products simultaneously to participating regulators in Australia, Canada, Singapore, Switzerland, Brazil, the United Kingdom, and the United States to facilitate collaboration and agreement on reviews for new cancer drugs and supplements for added indications. While OCE coordinates the program, each regulatory authority makes independent regulatory decisions.

The International Council for Harmonisation (ICH) continues to seek agreement from regulatory authorities and industry on new and revised standards for clinical testing and quality manufacturing of drugs and biologics. Current efforts aim to advance common strategies for validation and selection of analytical procedures in drug testing, for assessment and control of impurities in drugs, and for validating bioanalytical assays. A new initiative is developing guidelines for including pregnant and breastfeeding women in clinical trials, while another project is mapping harmonized approaches for regulating generic drug development (4). These and other ICH initiatives will be further discussed at its annual assembly Nov. 15–16, 2002 in Korea.

One obstacle to global biomedical regulatory harmonization, however, arises from an effort in the European Union to revise and strengthen its data privacy framework, despite the potential for blocking regulatory access to necessary clinical trial information and adverse event reports. The EU’s General Data Protection Regulations (GDPR) adopted in 2018 aim to limit the release of individual information related to a range of personal activities, including health care. Unfortunately, these policies have created difficulties for FDA bioresearch monitoring program (BIMO) inspections and for sponsors submitting information on study subjects in new drug applications and other documents.

A report from FDA’s Europe Office posted Aug. 9, 2022 describes how the GDPR prevents FDA BIMO investigators from reviewing and copying clinical health data involving EU citizens participating in multi-national clinical trails and in reviewing certain demographic and other information normally included in applications sent to the agency (5). While the EU data framework aims to protect private information on a range of activities, the resulting limits on FDA’s ability to assess EU health information pose difficulties in advancing a global clinical research framework and common regulatory policies.

Global Access to Medicines, Including Anti-TB Medicines

IFPMA, “Pharma Proposes to Work With G7 and G20 on a Joint Solution for Better Access to Vaccines and Treatments Around the World for Future Pandemics,” News Release, July 19, 2022.

ICMRA, “International Pilot Programmes to Streamline Regulatory Assessments and Inspections–Call For Industry Applications,” Press Release, June 2022.

ICH, “ICH Assembly Meeting, Athens, Greece, May 2022 A Successful Hybrid Meeting,” Press Release, June 1, 2022.

H. Messick, “How a European Data Law Is Impacting FDA,” 


Volume 46, Number 10
October 2022
Pages: 14-15

When referring to this article, please cite it as J. Wechsler, “Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing,” 

FDA backs joint reviews, common research policies, and modern production methods around the world.