Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

Rising numbers of confirmed cases of COVID-19, hospitalizations, and deaths as the last quarter of 2020 began signaled what may be the predicted second wave of the global coronavirus pandemic.

For geographic regions that experienced high infection and fatality rates in the spring, a dreaded sense of “here we go again” seemed to be taking hold. In my home region of the Northeast United States, healthcare experts and government officials weighed the economic considerations of keeping businesses and schools open and complaints of “pandemic fatigue” with the potential for the virus to spread rapidly.

Fortunately, healthcare professionals have made progress in identifying treatment options and protocols to treat COVID-19 patients, improving the odds of survival. Diagnostic testing has improved from the early days of the pandemic but is, according to many public health experts, insufficient to provide crucial information to address outbreaks in a timely manner. And many people—but again, not enough—learned to adhere to basic public health messages to wash hands, wear face coverings, and to practice social distancing.

One way to assess US preparation is to review action taken to resolve previous health emergencies. One lesson the pharma industry has not learned—for nearly two decades—is to effectively resolve drug shortages.

A recent report from the Center for Infectious Disease Research and Policy at the University of Minnesota (1) noted that 29 of 40 critical drugs used to treat patients with COVID-19 have experienced shortages, including propofol, albuterol, midazolam, hydroxychloroquine, cisatracurium, rocuronium, fentanyl, azithromycin, and vancomycin. A rapid increase in the demand for these drugs, coupled with production and supply interruptions related to the pandemic, and trade bans imposed by foreign manufactures were contributing factors to the shortages.

Other factors, such as quality-related production delays, lack of manufacturing capacity, raw materials shortages, or business decisions to stop making a drug are familiar causes for shortages. While drug shortages are tracked by FDA, the root cause often is not apparent due to a lack of supply chain transparency, the report noted.

The US dependence on unknown foreign suppliers for raw materials means patients do not know where the ingredients in their drugs are coming from. FDA lacks the information needed to anticipate the impact a disruption in the supply chain may have on the US drug supply.

Many consumer products—from fruit and vegetables to clothing to electronics—note the country of origin. An analysis of more than 40,000 prescription drug product labels, however, found that more than two-thirds did not report the name of the manufacturer or where it was made (1).

The report recommends a number of initiatives to address shortages, including the following:

A national entity—either existing or new—to analyze, predict, manage, and prevent drug shortages

A map of the US drug supply chain, including the source of starting materials and where APIs and finished drugs are manufactured

Prescription drug profiles detailing supply chain information, quality, and regulatory information listed on a consumer website

Ongoing research on supply chain resiliency and a warning system to alert for potential shortages.

The authors offer good suggestions; however, the initiatives must work in concert with patient demands for lower prices for safe, effective drugs, drug company profit goals, and the reality that the industry depends on a global marketplace to succeed.

The pandemic may kick-start a number of changes in the way drugs are made. Identifying and qualifying the supply chain deserves a top spot on the list.

COVID-19: The CIDRAP Viewpoint, Part 6 Ensuring a Resilient US Prescription Drug Supply

When referring to this article, please cite it as R. Peters, “Pandemic-fighting Drugs in Shortage, Again,” 

Articles

Resolving drug shortages starts with identifying the source of the problem.

Pandemic-fighting Drugs in Shortage, Again

People often embrace information sources that align with their personal beliefs and reject opposing viewpoints that they do not want to hear. When the source of the information is not subject to fact-checking or ethical standards, inaccurate information, disinformation, and outright conspiracy theories replace science-based expert insight and facts.

Disinformation from many different—and sometimes unknown sources—is contributing to a growing credibility problem for institutions normally entrusted with public health decisions. At the same time, actions by some of those institutions, including the Centers for Disease Control (CDC), FDA, and biopharma companies, may be lowering public trust in vital health matters.

Missteps, such as the September 2020 release, then retraction by the US CDC of a guidance on airborne transmission of the virus (1), undermine confidence in the very institutions that should be the “gold standard” for health information.

The credibility of pharmaceutical development, public health authorities, and FDA are in question, as illustrated in a survey by the Kaiser Family Foundation (KFF) (2). A majority of people (62%) surveyed from Aug. 28–Sept. 3, 2020 said they are concerned that pressure from the Trump Administration will cause FDA to rush approval of a vaccine without ensuring it is safe and effective. About 40% said FDA and CDC are paying too much attention to politics when reviewing and approving treatments or issuing guidelines and recommendations.

Despite the volume of information published by credible sources, the KFF survey found that nearly half of the respondents held at least one misconception about six coronavirus-related facts about the existence of a cure or vaccine, the effectiveness of hydroxychloroquine, whether children can transmit the virus, and the wearing of face masks.

When KFF conducted the survey in April 2020, 83% of respondents said they had a “fair amount” or “great deal” of trust in the CDC; in the latest study, that number dropped to 67%. Trust in Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the leading government figure on pandemic response, declined;78% of respondents in the April poll said they had a “fair amount” or “great deal” of trust in Fauci compared with only 68% in the September poll.

In an open letter issued in early September 2020, leaders of the Biotechnology Innovation Organization urged biopharmaceutical companies to ensure the “integrity, transparency, and objective assessment” of clinical data when seeking drug and vaccine approvals. Top executives of nine companies developing COVID-19 vaccines promised to adhere to the scientific process and regulatory guidelines and prioritize patient safety (3). And, career FDA leaders maintained that the agency is committed to science, while acknowledging it operates in a political environment (4).

The COVID-19 pandemic has been a new, unnerving experience for society. Scientific and medical communities scrambled to research, react, and develop appropriate medical responses. The lack of a coordinated, authoritative message about best practices to control the virus spread has fueled more than infections; it has sown distrust that will undermine further response and recovery.

1. M. Mishra, “US CDC Takes Down Coronavirus Airborne Transmission Guidance,” 

2. H. Hamel, et. al., “KFF Health Tracking Poll–September 2020: Top Issues in 2020 Election, The Role of Misinformation, and Views on A Potential Coronavirus Vaccine,” 

FDA’s “Gold Standard” Critical for Biopharma R&D

Career FDA Leaders Say Science Is Agency’s Guide

Rita Peters is the editorial director of 

When referring to this article, please cite it as R. Peters, “Fighting the (Dis)Information Pandemic,” 

Misleading messages contribute to eroding trust in public health agencies.

Fighting the (Dis)Information Pandemic

Bio/pharmaceutical companies have demonstrated the potential of innovation in response to the COVID-19 pandemic, initiating an estimated 175 vaccine programs—including more than 30 in clinical trials—and more than 500 therapy studies with half at clinical stage (1).
While these efforts largely have been commended, the work of scientists and researchers also has been subject to heavy scrutiny, often by people and institutions that are not familiar with the complexities of the drug development process.

In non-pandemic times, drug companies, industry suppliers, and contract service organizations discuss how they are employing processes, products, or services to shorten the time it takes to get a drug to market. The typical wait time, often counted in years, takes longer than most patients and medical professionals would prefer.

The progress made in COVID-19 vaccine and treatment development during the past six months is remarkable. A formidable amount of work stands in the road ahead to continue the research and development; assemble the materials, resources, and capacity to produce the vaccines and therapies; and determine an equitable distribution system.

In this issue, the editors take a look at the efforts of bio/pharma companies, contract development and manufacturing organizations, and materials and equipment to address pandemic-related response, as well as maintain ongoing drug development and manufacturing activities amid travel, communication, and business disruptions.

” Manufacturing Editor Jennifer Markarian reports on multi-pronged efforts to build out capacity for billions of doses of potential COVID-19 vaccines. The article explores how the urgent need for effective treatments and vaccines has spurred investment by drug companies, non-government organizations, and the federal government, triggering frequent announcements of new manufacturing agreements, facility expansions, and commitments to supply raw materials, drug components, and drug substances. The industry’s use of different vaccine platforms including—mRNA, DNA, viral vector, cell-based, and inactivated virus approaches—adds complexity to the coordination efforts. Read the article.

The quality and availability of APIs and other drug components, especially those sourced from offshore, were debated prior to the onset of the pandemic. Criticism of US reliance on foreign manufacturing ratcheted up as the pandemic’s impact on supply chains emerged, prompting government investment in a newly formed API manufacturer (Phlow) and a since-delayed investment in Kodak Pharmaceuticals, as well as an August 2020 Presidential Executive Order requiring the federal government to buy essential drugs from domestic manufacturers.

While the “made in USA” debate plays out, API suppliers have implemented new technologies, risk-based decision making, and increased customer communications to maintain a global supply chain. Efforts are described in “

Despite the great progress and investments made to date, science-driven studies still need to play out; that will take time. Bio/pharma professionals—trained to carefully assess risk when making decisions—are treading on dangerous ground when they allow outside factors to influence decisions that are not supported by data.

Previously, FDA was criticized for issuing an emergency use authorization (EUA) for hydroxychloroquine (later withdrawn). More recently, FDA issued an EUA for convalescent plasma—despite reservations from medical experts about the effectiveness of the treatment—following comments from the President that approval delays were politically motivated (2).

Honest assessments of the potential pitfalls associated with developing new treatments and vaccines can be bitter pills for those demanding immediate answers to swallow. However, patience and science will provide the best medicine to guide effective decisions about a return to normal life.

1. BIO, BIO COVID-19 Therapeutic Development Tracker, 

, accessed Aug. 26, 2020.
2. J. Wechsler, “

When referring to this article, please cite it as R. Peters, “Biopharma Gears Up Pandemic Response,” 

Amid high expectations for a vaccine, bio/pharma readies capacity, weighs pressures.

Biopharma Gears Up Pandemic Response

Patience may be a virtue; however, in today’s “I want it now” society, it often is in short supply. Immediate gratification is expected, be it a pizza delivery, customer service response, drug or vaccine to fight a pandemic. For an impatient audience, a slower-than-expected response can lead to complaints, criticism, and distrust.

Yes, I am using clichés; however, these adages help explain the distorted perception of time during the current pandemic, frustration with limits on personal freedom, and the need to temper expectations for when we “get back to normal.”

Time in 2020 has been skewed. It seems like it was yesterday—and years ago—that concern about the spread of the virus forced the closure of 

’s physical offices, relocating the staff to home offices. In reality, the stay-at-home guidelines have been in place for five months.

Like others, I would enjoy sharing a meal with friends, or attending a ballgame without worrying that the next person is six feet away and wearing a mask. Science tells me, however, that social distancing is the best defense against the virus. I choose to believe science.

An Albert Einstein quote offers an excellent description of this feeling of both fleeting and lagging time and suggests an effective way to handle anxiety and frustrations with the ongoing global crisis. “Time is relative; its only worth depends upon what we do as it is passing.”

Obviously, drug researchers are making the most of the short time that has passed since the virus was first discovered. The pace of research and race to get a COVID-19 vaccine has been accurately described as unprecedented, surpassing previous emergency vaccine programs. The time from viral genetic-sequence selection to first-in-human study was about two months; in comparison, in 2003 the Severe Acute Respiratory Syndrome (SARS) vaccine required 20 months to bring to clinic.

Meanwhile, drug companies are also racing to test new or existing therapies to treat the effects of the virus. Development efforts that typically take years have been compressed into months. As knowledge about the virus and its impact on humans continues to grow, treatments and public health practices are evolving and improving with time.

For some members of the general public who are not familiar with public health practices, the stay-at-home recommendations seem draconian. For those not familiar with the intricacies of drug development and manufacturing, new vaccines and treatments are not reaching patients fast enough.

While the pandemic has brought out the best in bio/pharma science and technology, it has, unfortunately, brought out negative behavior in the form of miscommunication—and even conspiracy theories—about the virus, public health orders, and drug company motives to combat the pandemic.

The result of this misinformation, whether intentional or accidental, is that potentially damaging information is presented as fact, with health implications for people who ignore public health advice or engage in harmful practices, as well as people in their communities.

Scientists from academia, government, and industry have shared knowledge and discoveries and published thousands of studies. This information sharing needs to extend to the public, in particular those that are accepting theories and advice that is not based on science. And, drug companies developing treatments and vaccines should share data; they should not raise unrealistic expectations.

Professionals engaged in science and technology can help explain why patience is not just a virtue but a necessity. It will take science some time to resolve the pandemic. What we do during that period will determine if it was time well spent.

When referring to this article, please cite it as R. Peters, “xxxxx,” 

Time sure flies, except when you are waiting for something to happen. 

It’s Time to Listen to Science

	For researchers involved in the development of new treatments and vaccines to combat COVID-19, the past five months have been a scramble to research potential therapies, collect and analyze data, accelerate clinical trials, and plan manufacturing processes. While the biopharma industry knows these development efforts are moving at record pace, for some patient groups, policymakers, and the public, the efforts are not moving fast enough.

	When someone is seriously ill, family members and healthcare providers are desperate for an effective treatment. History has shown that many “promising” therapies initially raised the hopes of patients, only to disappoint when the therapy did not work as predicted. During this global pandemic, public and policymaker pressure can make the R&D task more difficult.

	For example, earlier this year, hydroxychloroquine was touted as a possible treatment for COVID-19; FDA faced criticism when it issued emergency use authorization (EUA)-based on limited data-on March 28, 2020. When subsequent clinical trials showed the drug was unlikely to be effective as a treatment for COVID-19, and the cardiac side effects outweighed the benefits, FDA withdrew the EUA on June 14, 2020.

	Keeping pace with the rapidly emerging research about the SARS-CoV2 virus and vaccine and therapy development is a monumental task. Thousands of scientific papers have been released, and drug companies and research organizations have been collaborating and sharing information on levels described as unprecedented. These findings need to be reviewed to ensure decisions about therapies are based on data rather than political motives, or undue influence.

	Missteps and misinformation related to diagnostic testing, distribution of personal protective equipment, and the wearing of face masks have eroded public trust in the abilities of FDA and other government authorities to manage the pandemic. While anecdotal evidence points to the availability of a vaccine before the end of 2020, public confidence in FDA, the government, and drug companies needs to be established.

	During a BIO 2020 digital event on June 10, 2020 (1), FDA Commissioner Stephen M. Hahn emphasized the importance of science-based decision making, as well as regulatory authority independence to make approval decisions, key factors to assuring the public that the vaccines and therapies are approved with public safety and health at the forefront.

	As applications for emergency use and investigational new drug applications poured into FDA in the initial days of the pandemic, Hahn says the agency reviewed all applications, and prioritized those with the highest level of science behind them and the greatest chance of making it to clinical trials.

	Some bio/pharma companies are participating in and receiving funding from the federal government’s Operation Warp Speed and Accelerating COVID-19 Therapeutic Interventions and Vaccines programs. Hahn noted, however, that FDA has established a “barrier” between itself and these public-private partnerships to reinforce the agency’s regulatory independence. “We will prioritize based on science, we will not prioritize based on who comes through the door,” he said. “We are agnostic with respect to the sponsor, but we are very much aligned with where the science appears to us to be the highest level.”

	Hahn said he understands the “enormous amount of pressure” related to the pandemic; however, the agency’s “North Star” will be data and science. The agency may have to update decisions as new data are available, he noted, but will continue to make decisions based on science.

	1. BIO, Fireside Chat with FDA Commissioner Dr. Stephen M. Hahn, BIO 2020 Digital Event, June 10, 2020.

	When referring to this article, please cite it as R. Peters, “Navigating Uncharted Waters" 

FDA Commissioner Hahn commits to a science-based review and approval process.

Navigating Uncharted Waters

	Through May 2020, more than 100,000 deaths in the United States were attributed to COVID-19; there were more than 350,000 deaths globally. Amid the swirl of news and developments in the past three months, a great deal of information-and misinformation-has circulated the disease and options to combat it.

	The COVID-19 pandemic has introduced new terminology and concepts to the public and highlighted the need for refresher courses on good hygiene. Well-established public health practices, such as staying home if you were sick and washing your hands with soap and water for 20 seconds, had to be driven home through public education programs.

	Other recommended practices, which some perceived as infringing on personal choice, were met with more resistance and less compliance. Demonstrators have protested the closure of public spaces and businesses. Some people do not understand-or are not adhering to-the concept of social distancing. And, the recommendation to wear a facemask in public has become a political flashpoint.

	Public health officials and healthcare providers have had a difficult task communicating about and getting the public to adhere to practices to help control the spread of the virus. The more complex a topic is the more difficult it can be to gain public acceptance and adherence.

	Effective vaccines and therapies are seen as a pathway to return to life as it was before the pandemic. In the past three months, many “promising” therapies and vaccines were heralded in press announcements, often with limited supporting data.

	Operation Warp Speed-the name of the Trump Administration’s program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics-announced lofty goals of producing hundreds of millions of doses of vaccine by the end of 2020.

	Many experts do not believe that an effective, approved vaccine that provides at least some protection will be available in less than one year. And, concern that the rush to get a vaccine to market will compromise safety may work against efforts to build herd immunity among the population.

	Herd or community immunity occurs when a sufficient percentage of the population is immune to a virus because enough people recovered from the illness or were vaccinated. Absent a vaccine, most nations went into lockdown.

	Sweden adopted any alternative approach: build herd immunity among its younger, less at-risk population, while leaving most businesses and public spaces open. As of late May, the nation’s immunity rate was expected to be well below projections, while the death rate per capita was significantly higher than surrounding countries (1).

	Epidemiologists estimate that 70% or more of the population must be immune to the novel coronavirus to achieve herd immunity. The portion of the US population that has immunity is unknown due to issues with inaccurate and limited testing and reporting (2).

	The Centers for Disease Control reports that less than half of the adults in the US get an annual influenza vaccine (3), an indication that the entire population may not line up voluntarily to get vaccinated. Achieving herd immunity will require health officials to educate a wary and confused public of the science-based merits of a vaccine, a more difficult task than getting people to wash their hands.

	1. H.J. Mai, “Stockholm Won’t Reach Herd Immunity in May, Sweden’s Chief Epidemiologist Says,” 

, May 25, 2020.
	2. G. D’Souza and D. Dowdy, “What is Herd Immunity and How Can We Achieve It With COVID-19?” John Hopkins Bloomberg School of Public Health, April 19, 2020.
	3.  CDC, Vaccination Coverage Among Adults in the United States, National Health Interview Survey, 2017, 

	When referring to this article, please cite it as R. Peters, “Are We All In This Together?" 

Achieving herd immunity will require testing, data, a vaccine, and public support. 