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

Jill Wechsler

For years, FDA officials have been pressing pharmaceutical manufacturers to invest in quality production systems to avoid plant shutdowns and manufacturing stoppages. The current baby formula shortage crisis, while not involving drugs, illustrates the catastrophic effects of company failures to ensure that regulated facilities reliably meet safety and quality standards. But despite multiple agency initiatives to encourage quality drug production, the response has been disappointing. A main factor is that payors and healthcare systems are reluctant to pay extra for potentially more reliable supplies. Therefore, agency leaders once again are moving to develop a rating system to identify those drug manufacturers with more dependable production operations and to encourage market support for the resulting medical products.

Under the current system, serious shortages have continued to erupt for many critical medicines, notably for many low-cost, common treatments that carry low prices. The situation has been aggravated by the COVID-19 pandemic, where supply chain disruptions have blocked access to needed ingredients and production supplies such as filters, stoppers, and IV fluid bags, adding to production difficulties and costs.

FDA has worked with the pharmaceutical industry over the past decade to devise ways to better ensure patient access to medicines, particularly critical treatments. Advance notification to FDA of production changes or facility closures likely to lead to shortages has enabled FDA to expedite reviews and inspections to remedy many supply problems or identify other manufacturers able to step in. The CARES Act (Coronavirus Aid, Relief and Economic Security Act) enacted in March 2020 expanded the information FDA may collect on manufacturing discontinuations and interruptions and enhanced agency authority to expedite approvals and inspections of drugs to offset shortages, as discussed in the agency’s annual report to Congress on drug shortages for 2020 (1).

Despite these efforts, shortages continue for both new and low-cost products such as IV fluids and widely used painkillers due to limited manufacturing lines and ramped-up demand for new vaccines and therapies. But quality-related issues are the most prominent cause of shortages, noted Valerie Jensen, associate director of the drug shortage staff in the Center for Drug Evaluation and Research (CDER). She explained at FDA’s webinar on CDER’s quality management maturity (QMM) program on May 24–25, 2022 that 55% of drug shortages in 2021 were attributed to manufacturing delays and quality-related issues.

The situation has bolstered FDA’s initiative to develop a rating system to incentivize drug manufacturers to create QMM programs for their facilities. The aim is to provide evidence for drug purchasers, such as health providers and payors, for rewarding pharmaceutical companies that invest in more modern and reliable QMM systems and thus are able to ensure product value, as proposed in FDA’s 2019 report on the Root Causes and Potential Solutions to Drug Shortages (2).

FDA outlines its proposed QMM rating system in a white paper issued in April 2022 on how QMM is “essential” for a stable US supply chain of quality pharmaceuticals (3). However, manufacturers have long objected to publicly availableratings of their operations and
continue to criticize specifics in FDA’s plan for collecting metrics data in the proposed four areas. Generics makers and contract manufacturers are notably opposed to the current plan, and biologics firms don’t want to be included.

A publicly available QMM rating system could support “resilience contracting” by health plans, based on quality and reliability in addition to price, observed drug shortage expert Erin Fox, senior pharmacy director for University of Utah Health, at the FDA QMM workshop. She acknowledged that “quality and reliability will cost more,” but that the cost of shortages has a broader impact. One proposal, she said, is that accreditation organizations for hospitals and health systems should add to their evaluations the QMM ratings on the medicines purchased and on the frequency of shortages that negatively affect patient care. Fox also backs an international trade agreement that prohibits export bans on key components of global medical products.

FDA also advises manufacturers to anticipate and prevent drug shortages by establishing “redundancy risk management plans” (RMPs), as detailed in FDA draft guidance published May 19, 2022 (4). RMPs are required for producers of life-supporting drugs and their APIs and medical devices needed to administer such critical treatments. FDA also recommends RMPs for drugs to treat rare diseases, medical countermeasures needed in public health emergencies, sole source products, drugs with only one API manufacturer in the supply chain, and drugs made in facilities that have been cited by FDA for manufacturing problems.

The guidance advises manufacturers to develop RMPs that identify likely hazards to production and estimate the potential for something to go wrong, similar to the process outlined in the Q9 Quality Risk Management guidance from the International Council for Harmonisation (ICH). Risk control components likely to avoid disruptions include building redundancy into manufacturing operations, assessing supply chain controls, and establishing strong relations with suppliers. Manufacturers also should conduct annual risk reviews to revise RMPs where needed.

CDER officials expect drug shortages to continue, even though the agency prevented more than 300 shortages this past year by implementing regulatory flexibility and expediting submissions, commented CDER Deputy Director Douglas Throckmorton at FDA’s annual regulatory education for industry conference June 6, 2022. CDER is working hard to maximize its use of added information from manufacturers to better understand the real reasons for potential drug shortages and to be able to intervene by finding another manufacturer or a missing component. It’s critical, he said, to have the “right kind of information from manufacturers to us.”

Drug Shortages: Root Causes and Potential Solutions

Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals,

Risk Management Plans to Mitigate the Potential for Drug Shortages, Draft Guidance Documen

When referring to this article, please cite it as J. Wechsler, “FDA Advances Quality Initiatives to Combat Drug Shortages,” 

Articles

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

FDA Advances Quality Initiatives to Combat Drug Shortages

Initiatives to learn more about the impact of drugs and medical products on diverse population groups is driving efforts to assess the effect of medicines and vaccines on pregnant and lactating patients. The aim is to expand and clarify methods for obtaining information on medicines used by or needed for this population through clinical trials and postapproval studies, as seen in a number of policy initiatives and expert assessments of ways to obtain reliable information on how drugs affect these patients.

Pregnant women traditionally have been excluded from preapproval studies due to concerns about potential damage to the health of the mother and the fetus. Unfortunately, that has created a serious dearth of useful information on safe treatments for this group, including individuals coping with serious conditions. While FDA has required sponsors to include in labeling available information on drug impact for this population, the agency does not require research sponsors to collect such data in clinical trials.

Yet the ongoing interest in including more pregnant and lactating women in clinical trials continues to generate research and strategies on the subject, as presented at a

 on the issue organized by the Forum on Drug Discovery, Development and Translation at the National Academy of Sciences, Engineering and Medicine (NASEM). The program on June 16–17, 2022 examined the ethical issues and gaps in treatment information due to the exclusion of this population from clinical research. Experts reviewed the laws and regulations governing R&D for pregnant and lactating persons, along with opportunities to improve evidence on the risks and benefits of drug products for these patients. A report will be issued on strategies for overcoming barriers to clinical research, for addressing liability concerns, and short- and long-term proposals for moving forward.

FDA has encouraged pregnant and lactating persons to join registries

 that collect information on exposure to drugs and vaccines during pregnancy and after. And more recently, the agency and researchers have explored how broader use of real-world data (RWD) and postapproval studies can enhance understanding on the impact of drugs on pregnant and lactating women. This topic was the focus of a 

workshop organized by Johns Hopkins on May 9, 2022

, where experts examined strategies for leveraging real-world evidence (RWE) to study medication use in pregnancy and lactation.

 on how researchers can obtain information on drug effects on pregnant and lactating women through pharmacovigilance programs, electronic health record data systems, surveillance programs, and the broader use of RWD to inform the safety of drug use for this population. A 

 describes how drugmakers should conduct clinical lactation studies for drugs likely to be used in women in this situation.

This issue, moreover, has gained international attention as part of efforts to advance research on women in a wider range of health conditions. The International Council for Harmonisation (ICH) agreed at its May 2022 meeting in Athens to add this topic to its list of issues warranting global standards. A proposal developed by officials at FDA, the European Medicines Agency (EMA), and the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) calls for 

on a global framework for including pregnant and breastfeeding individuals in clinical trials. The aim is to benefit this often-ignored population and to better inform providers and the global pharmaceutical industry.

Of note, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recently 

said it was updating its system for providing advice

 on use of drugs for pregnant and breastfeeding women. This involves expanding its registry and information system to improve data collection and to provide speedy consultations through online systems tracing the effects of medicines on this population.

Many of these initiatives build on the report issued in 2020 by the national Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC), which was initiated by the 21st Century Cures Act of 2016 to address gaps in knowledge and research on this topic. That

 panel called for broader pregnancy registries, more research on treatments for this group, design of studies for timely collection of relevant data, and linking health records of mothers and children to address these issues.

And biopharma companies agreed in the latest Prescription Drug User Fee Act plan (PDUFA VII) to support efforts to determine what data and post-market safety signals best indicate exposure to medication in pregnancy and how that may help assess the effects of drugs and vaccines in pregnant women. FDA will explore the use of pregnancy registries and electronic health record systems in establishing a standardized process for this purpose at a 

hat through demonstration projects and issue a proposed framework and guidance by 2027.

Regulators wish to expand and clarify methods for obtaining information on medicines used by or needed for pregnant and lactating individuals through clinical trials and postapproval studies.

Regulators Seek More Drug Effects Research Related to Pregnancy and Lactation

FDA is at a “pivotal moment” for the nation’s public health and for global well-being due to the potential for realizing important gains in medical treatment based on science, 

Commissioner Robert Califf told the Washington legal and regulatory community in June 2022 at the annual meeting of the Food and Drug Law Institute 

(FDLI). He aims to address these challenges by improving FDA supply chain management in all areas, with digitally integrated systems that support preemptive actions and permit swift reaction to product shortages. Another priority is to counter widespread misinformation about vaccines and medical products through an emphasis on science-based decision making at the agency and to advance medical product development based on appropriate communication between agency experts and those in regulated industry.

Califf emphasized the importance of improved information and data management systems in all FDA operations to support agency oversight and decisions about medical therapies. A priority is to FDA’s foods program, which will require sufficient funds from Congress to support something like a “21st century cures” initiative for food similar to that enacted to modernize and enhance the agency’s oversight of medical products in 2016. Under the current system, Califf noted that food producers don’t even have to tell FDA if they find contaminants in products awaiting shipment, limiting the agency’s ability to anticipate serious supply problems, such as the ongoing infant formula crisis.

At the same time, Califf defended the agency’s “appropriate” engagement with regulated companies as valuable for evaluating “the promise and risk” of new products and technologies. The broad knowledge of FDA staff about the full range of products in development—including many failures—can help guide developers to efficient pathways and prevent wasted and duplicative efforts—including clinical trials that could harm human subjects.

Similarly, Principal Deputy Commissioner Janet Woodcock urged a better understanding of the challenges and difficulties surrounding the many regulatory and scientific decisions made by FDA staff and leaders in another address at FDLI, which acknowledged the agency’s serious error in approving long-release opioids for market. Woodcock noted that a science-based regulatory process, as at FDA, must issue regulations and policies that implement laws, a process that involves interpretation and inevitably generates dissent. Although science aims to assess the facts, many decisions are “surrounded by a cloud of uncertainty,” she said. Consequently, FDA’s critical approval of long-release opioids in 1995 was based on projections of harm and prescribing behavior presented at the time that were way off, Woodcock conceded. However, she acknowledged being pessimistic about this situation improving in the near future unless scientists and policy makers are able to communicate more broadly about the “big picture” of the uncertainty that inevitably surrounds agency decisions.

Califf raised similar concerns about “the growing dissemination of misinformation and disinformation about science, medicine, and the FDA which is putting patients and consumers at risk” at the FDLI conference and also at the BIO International Convention in San Diego. Misinformation, he told biotech leaders, is the leading cause of death in the United States, noting that almost all COVID-19 deaths now are preventable if patients become fully vaccinated and boosted. Misinformation, moreover, hampers the appropriate use of effective treatments for chronic diseases. It is paradoxical, Califf noted at BIO, that even though America is “innovating for the world,” US life expectancy is low, especially compared to other wealthy nations.

Califf observed at FDLI that he agreed to return to FDA last year after a previous stint as the agency’s leader in hopes of helping to modernize agency operations to prevent future critical delays and product shortages. This is a “pivotal moment” for the agency’s future effectiveness, he said, emphasizing that changes are needed to “stay ahead of the industries we regulate and the technology, science, and communications those industries employ.”

FDA is at a pivotal moment because of important gains in medical treatment based on science.

FDA Leaders Seek to Build Public Trust in Science and Gain Support for Regulation

A broad bill carrying multiple proposals for revising and expanding FDA programs and policies, in addition to reauthorizing user fees critical for funding FDA operations, was endorsed by the Senate Health, Education, Labor and Pensions (HELP) Committee this week. The legislators’ approval of the FDA Safety and Landmark Amendments (FDASLA) by a 13–9 committee vote sets the stage for full Senate reauthorization of industry fees to support oversight and development of prescription drugs, generic drugs, biosimilars, and medical devices.

The measure adopts a host of new programs and requirements that stand to make significant changes in how FDA regulates a range of medical and food products. However, many of the specific additions and revisions in the Senate bill differ from legislation already passed by the 

(HR 7667). The situation requires the legislators to reconcile the two measures in order to enact final legislation by the current target of August 1, 2022.

The extensive Senate HELP bill builds on a 

backed by HELP committee chair Patty Murray (D-WA) and ranking Republican Richard Burr (R-NC). An important provision backed by Murray clarifies the pathway for importation of drugs from Canada, expanding the range of eligible products. Murray also endorsed new proposals for strengthening FDA oversight of cosmetics and dietary supplements, which establish a broad range of new requirements and regulatory processes for these products. In addition, the Verifying Accurate Leading-edge IVCT Development (VALID) Act backed by Burr updates FDA policies for authorizing 

 diagnostics, with an eye to enhancing the agency’s ability to evaluate effective lab tests in public health crises.

Moreover, the legislators moved to address the current infant formula crisis by establishing an Office of Critical Foods in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). It provides a premarket review process for manufacturers of infant formula and requires FDA notification of production disruptions and recalls and switches to appropriate substitutions. A number of FDA reports to Congress on the program are included, along with revised procedures for FDA’s mailroom operations to prevent the loss of whistleblower reports and other important documents related to these and other regulated products.

Additional sections of the bill offer a range of enhancements for testing and marketing drugs and medical products. The development of treatments for rare diseases gains support from a new pilot program and other provisions. Competition from generic drugs may be enhanced by authorization of labels with certain differences from brands, while import is permitted for certain medical devices made overseas. FDA’s accelerated approval pathway is updated to ensure its support for innovative cardiology and neurology therapies, as well as cancer treatments. Added provisions aim to discourage the use of animal tests in developing drugs, cosmetics, and other products. And FDA is required to move forward with policies to authorize over-the-counter hearing aids.

Important to FDA officials are provisions designed to expedite and simplify agency hiring practices and its ability to retain talented scientists and medical personnel. At the same time, the legislators extend oversight for FDA’s IT modernization program, requiring reports and clear goals and priorities to ensure that the added funds requested for this agency-wide initiative are effective and well-spent.

The wide scope of the legislation is not surprising, given the long history of policy makers adding multiple pet initiatives to this must-pass measure. As fees from regulated companies have become a main source of support for FDA oversight of the testing and development of critical medical products, the challenge remains to continue this financial support for the agency without enacting measures that will overload or undermine FDA and industry operations.

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access. 

FDA User Fee Legislation Advances in Senate

Although FDA announced in February 2022 that it was resuming “normal, routine domestic surveillance” of drug and medical product manufacturing facilities, many of the innovations and modifications for site inspections adopted during the COVID-19 pandemic will continue to play a visible role in agency compliance and enforcement operations. FDA’s Office of Regulatory Affairs (ORA) delayed or cancelled most onsite inspections during the past two years due to travel restrictions and infection concerns, but now seeks to resume active inspections where needed and practical (1).

This shift, however, does not signal an end to FDA’s wider use of paper document reviews and of virtual site visits, or Remote Interactive Evaluations (RIEs), in ramping up oversight of biopharma manufacturing and research operations. These strategies notably reduced agency inspection costs, while enabling timely detection of compliance issues, and FDA sees value in continuing its expanded reliance on documents and records, on inspection reports from trusted regulatory authorities, and on wider use of remote real-time review of records and plant operations to provide assurance of proper manufacturing and clinical research operations (2).

Judith McMeekin, associate commissioner for regulatory affairs, pointed out during a presentation sponsored by the Alliance for a Stronger FDA on April 6, 2022 that ORA saved nearly $40,000 in 2020 and 2021, providing resources to develop a foreign travel planning system, expand personnel training, enhance information systems, and upgrade labs. FDA analysts are comparing the benefits and shortcomings of onsite inspections vs. record requests to develop criteria for revising or continuing these alternative practices.

More flexible inspection programs could gain from legislation before Congress to reauthorize FDA user fees and update agency operations and policies. The bill includes a provision to clarify FDA’s authority for collecting manufacturing records from medical device makers in advance or in lieu of field inspections and also for clinical study sites under FDA’s bioresearch monitoring program (FDA already has such authority for drugs). The measure also clarifies agency use of inspection findings of trusted foreign regulatory authorities in determining the need for preapproval inspections (PAIs). The bill requires FDA to post more information on the findings from drug and device inspections, such as warning letters and import alerts. And to expand unannounced FDA inspections of foreign drug establishments, the legislators propose a new pilot program to increase such site visits and to evaluate the impact on both domestic and foreign facilities (3).

In response to these developments, FDA has worked to better explain its criteria for selecting and methods for conducting more remote and alternative facility assessments. At the recent FDA Generic Drugs Forum, staffers from the Office of Pharmaceutical Manufacturing Assessment (OPMA) in the Center for Drug Evaluation and Research (CDER)’s Office of Product Quality (OPQ) explained that FDA will weigh the need for an on-site inspection based on a risk-based assessment of product, process, and facility risks (4). This involves scrutiny of records and other manufacturer information from trusted regulatory authorities.

Such information on a firm’s compliance history, process risks, manufacturing experience, and previous alerts, recalls, and complaints will help determine whether a PAI is needed or if FDA can assess the firm’s capacity for risk mitigation and GMP compliance from company and regulator records. When FDA considers an RIE advisable, it will discuss the logistics, scope, and expectations with the manufacturer, request needed documents from the firm in advance, and outline its main questions or concerns and the logistics for conducting a remote facility tour. Such virtual site visits also can help all parties prepare for a future onsite inspection, if warranted, but do not qualify as formal inspections per se. They are voluntary for the company, but a refusal to cooperate with an RIE request could delay product approval.

OPMA staff fellow Alexander Gontcharov described an RIE for a foreign manufacturing facility utilizing a new unit of operation to produce delayed-release tablets and capsules. This involved four three-hour sessions with a facility “walk-through” utilizing a laptop on a cart with external cameras and microphones. Another RIE for a new unit producing new ointments and liquid products had three four-hour sessions that used a portable tablet PC with Wi-Fi connections. FDA investigators viewed warehouses, labs, and production areas, as well as document control systems. Inspection findings may be specified in a close-out memo, or FDA may later send a letter identifying difficulties found at the facility and if an on-site inspection is needed.

The shift to remote assessments is reflected in the rise of warning letters that involve alternative inspection tools, according to the 2021 annual report from CDER’s Office of Compliance (OC) (5). While FDA exercised enforcement discretion in multiple cases to avoid shortages of critical medicines, OC reports a rise in drug adulteration warning letters based on sample testing and on information from records requests. In addition, OC conducted more than 45 remote regulatory assessments of clinical sites under the agency’s biomedical research compliance program. An FDA draft guidance published in April 2021 advises manufacturers on how the agency seeks to conduct this growing range of remote evaluations (6).

Overall, FDA advises manufacturers to recognize the importance of RIEs and to query about any unclear agency information requests. While FDA recognizes that RIEs are not equivalent to full inspections and that the agency only can see what the firm makes available, these alternative tools have cut the need for on-site PAIs in half and helped the agency meet user fee approval goals for 90% of applications this past year.

FDA Fact Sheet, Remote Regulatory Assessments (RRAs), ORA’s Office of Medical Products and Tobacco Operations RRA Activities During Coronavirus Disease 2019 (COVID-19) Public Health Emergency

The Food and Drug Amendments of 2022 (FDA 2022), Section by Section Summary, Title I: Fees Relating to Drugs

Use of Alternate Tools for Inspections During COVID-19 Pandemic,” 

presentation at Generic Drugs Forum 2022: The Current State of Generic Drugs, April 26–27, 2022.

FDA, 2021 Annual Report, Office of Compliance, Center for Drug Evaluation and Research, 

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

When referring to this article, please cite it as. J. Wechsler, “FDA to Continue Inspection Efficiencies After Pandemic” 

FDA will use virtual site visits even after resuming active inspections.

FDA to Continue Inspection Efficiencies After Pandemic

As policy makers and consumer advocates continue to demand reductions in prescription drug prices, manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers (PBMs). The charges range from using formularies to curb the use of important but expensive medicines, to requiring lengthy procedures for patients to gain coverage of costly treatments. 

 moreover, claim that PBMs encourage consumers to use more expensive brand drugs that are more profitable to the plans, even though these tactics harm competition and undermine efforts to develop less costly medicines. New legislation from leading Senators aims to address these concerns, while the Federal Trade Commission (FTC) is moving to launch a broader investigation of PBM practices.

With Democrats now controlling FTC’s agenda, the Commission has 

on how the growth in PBM formulary exclusions can limit patient access to medicines. The three leading PBMs—CVS Caremark, Cigna/Express Scripts, and UnitedHealth/OptumRx—manage about 80% of drug benefit plans offered by insurers and health plans and raise concerns among policy makers that excessive market concentration enables the middlemen to control drug coverage and reimbursement, as spelled out in the 

Independent pharmacists are leading the charge with a call for attention to how PBMs, working with big pharmacy chains, reduce reimbursement and steer patients away from smaller pharmacies. The National Community Pharmacists Association (NCPA) has called on the FTC to investigate these activities and to initiate legal action against PBMs for certain unfair or deceptive business practices.

Leading medical groups similarly blame PBMs for limiting patient access to vital medicines through formulary tiering practices and coverage policies. The 

has been vocal in calling for legislation to require PBMs to pass on negotiated savings to patients, instead of retaining high rebates and fees. And the 

American Hospital Association cites PBM “white bagging” programs 

that require cancer patients to obtain a treatment for infusion in a clinic from a separate specialty pharmacy.

Meanwhile brand manufacturers point to formulary exclusions that steer patients to select drugs from firms offering steep discounts and high rebates, while limiting coverage of many innovative but expensive therapies. The Pharmaceutical Research and Manufacturers of America (PhRMA) cites a 

arm of major drug distributor AmerisourceBergen, which presents data on how leading PBM formularies exclude access to more than 1000 medicines, leaving patients with limited and more expensive treatment options. PhRMA further notes that 

PBMs often exclude access to less costly insulins

 in favor of higher priced versions that offer large rebates to the plans.

proposed a range of measures to limit these and other PBM programs. 

The latest comes from Sens. Maria Cantwell (D-Wash) and Chuck Grassley (R-IA), who are co-sponsoring a bill to limit “spread pricing” and other PBM practices seen to affect competition in the marketplace. A main provision in their Pharmacy Benefit Manager Transparency Act of 2022 would prevent PBMs from charging health plans and payers more for a drug than what they reimburse the pharmacy. Additional sections would block spread pricing and “claw backs” of payments to pharmacies; require full PBM disclosure of rebates, costs, prices, fees, and other transactions with health plans and payers; and require PBMs to report differences in rates or fees to unaffiliated vs. affiliated pharmacies. The measure also requires FTC to report to Congress on PBM practices and to protect whistleblowers from being punished for bringing PBM violations to light.

As chairman of the Senate Commerce Committee, Cantwell already held a hearing in May on PBM practices and the need for legislation to establish a more equitable system for patients to access needed medicines. The Senate Finance Committee, where Sen. Grassley is the ranking Republican, is also examining these issues, as will relevant House committees. The Biotechnology Innovation Organization (BIO) applauded the Senate measure as well as ongoing FTC efforts to examine the role PBMs play in the biopharma market.

Pharma mergers also face FTC, DOJ scrutiny

In a separate move, the FTC has scheduled a public meeting to assess the impact of pharmaceutical company mergers on competition, innovation, and consumers. The Department of Justice Antitrust Division will co-host with the FTC a two-day workshop June 14 and June 15, 2022, to examine pharma sector market competition and merger remedies and how such actions affect biopharma innovation. This meeting was recommended by the Multilateral Pharmaceutical Merger Task Force, formed in March 2021 by the FTC to gain input on appropriate competition analysis from state attorneys general and officials in Canada, the United Kingdom, and the European Union. The workshop will be webcast each day at 

Manufacturers are aligning with pharmacists and providers to blame high drug costs and limited patient access on pharmacy benefit managers.