What did we learn from last week’s FDA vaccine advisory committee meeting?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

On October 22, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss the development, authorization, and licensure of COVID-19 vaccines. The meeting was not focused on any particular vaccine candidate; rather, it gave the FDA an opportunity to seek more general guidance about the process from outside experts. In this post, we explain what advisory committees like VRBPAC do, what happened at the meeting last week, and what this means for the COVID-19 vaccine timeline.

What do FDA advisory committees like VRBPAC do?

The FDA uses 31 advisory committees to provide the agency with independent recommendations on regulatory matters based on reviews of evidence from the agency, product sponsors, and members of the public. For example, VRBPAC has 17 members from outside the FDA, including academics, government scientists, and industry representatives, with expertise covering relevant scientific, clinical, statistical, and legal issues. Membership is supposed to be “fairly balanced,” including “ethnic, gender, and geographic diversity, as well as people with recognized expertise and judgment in a specific field” and “industry and consumer representation.” The FDA also has strict conflict of interest rules, and three VRBPAC members are recused from COVID-19 meetings due to their involvement in research on COVID-19 vaccines. They have been replaced by temporary members.

The work of these expert advisory committees matters to agency decisionmaking. In a review of the 376 advisory committee meetings held between 2008 and 2015, Audrey Zhang, Jason Schwartz, and Joseph Ross found that the FDA reached a final decision that contradicted the advisory committee’s recommendation in just 22% of cases. In those cases of disagreement, the FDA tended to be less likely to approve new products than more likely to do so.

More than half of advisory committee meetings are product-specific, in which the FDA asks its advisory committees to make recommendations about particular products, including whether they ought to be approved or subject to additional safety restrictions. But many meetings are more general, such as those asking an advisory committee to help the agency determine how to evaluate classes of products.

Advisory committees play an important role in providing the FDA with additional expert perspectives on novel issues. But they also provide other benefits. Perhaps most notably, they increase the transparency of an often-opaque process. The FDA typically discloses very little information about its approval process and the evidence used in support of approvals, in part because of concerns involving the disclosure of trade secrets. Information provided to the FDA’s advisory committees, however, is made publicly available on the FDA’s website. This transparency can help improve public trust in the FDA, which is of particular concern in the COVID-19 context.

What happened at the October 22 VRBPAC meeting?

On October 22, the VRBPAC held an open, online, public meeting concerning its standards for approving a vaccine against COVID-19. (The meeting was simultaneously broadcast on CSPAN and YouTube.) Prior to the meeting, the Committee made the agenda and briefing materials publicly available; the meeting featured presentations from Committee members, staff from the FDA, CDC, NIH, BARDA, the Reagan-Udall Foundation, and a variety of members from industry. Introductions alone took 23 minutes to complete; the meeting lasted almost nine hours.

Somewhat surprising for lay observers was the absence of a discussion of any particular vaccine candidate, including the four currently in Phase III clinical trials in the US. Instead, the meeting focused on the standards of such trials and the legal authority (and limits) for approval. While a nine-hour meeting focusing on the particulars of vaccine safety and efficacy standards sounds...dense...there were a number of broader, important takeaways likely to be of larger interest.

First, and most important, the VRBPAC gave a number of reassurances that it would advise the FDA to continue to uphold rigorous safety standards despite political pressure to quickly approve a vaccine. It was clear that even if an Emergency Use Authorization (EUA)—a shortcut to the typical and more formal approval process—were available for a vaccine, it could not be used without the completion of a clinical trial (through Phase III). In addition, the Committee noted that it would strongly encourage the completion of ongoing trials even when another vaccine candidate is authorized or approved so that the Agency can track outcomes.

Second, the Committee reaffirmed its commitment to safety follow-ups even after a vaccine is authorized or approved. The post-approval follow-up study envisioned by the VRBPAC would contain roughly 3,000 participants—enough, one hopes, to track any serious adverse events arising late from the vaccine. At the same time, however, the Committee noted that this post-approval follow-up would not necessarily conform to the diversity standards otherwise needed for the clinical trials; in clinical trials, these requirements are crucially important to ensure the vaccine works in a immunologically diverse population. Whether this limitation of post-licensure studies will prevent the discovery of adverse event information remains unseen—and will likely remain unseen until long after a vaccine has come out. But for now, the VRBPAC—to its credit—is laudably committed to following up on any licensed vaccine after it has been deployed in the wild.

Third, the Committee was honest and forthcoming about growing anti-vaccine sentiment and a greater loss of trust in the FDA. This includes some pointed skepticism from minority populations regarding clinical trial participation—and especially the Black community given the historical backdrop of the Tuskegee Study and other abuses. The Committee’s very existence aims to combat this lack of trust, including by helping the agency follow the guidance of Coach John Wooden: “Be quick but don’t hurry.”

What does this mean for the COVID-19 vaccine timeline?

For starters, we can’t say exactly what the October 22 meeting will mean for the FDA. As noted, the VRBPAC is an advisory committee, not a decision committee. That said, the FDA follows its advice most of the time, and in a space where the FDA looks to be trying to maintain independence against administration pressure and to follow the science, the advice of the Committee seems especially likely to be heeded (assuming consistent FDA leadership). And FDA officials also contributed to the discussion.

The biggest implication from the Committee meeting was an apparent preference for using Expanded Access (EA) over EUAs for any early access to COVID-19 vaccines. Under an EUA, a vaccine could be authorized under more lenient standards, and with less data, than the normal approval process (though the FDA has implemented stronger standards for COVID-19 vaccine EUAs than is normal for the EUA process). In contrast, the FDA’s EA program does not provide widespread authorization: it allows more tightly controlled access to products that remain under investigation.

A key downside of a COVID-19 vaccine EUA is that it would complicate clinical trials, both for the authorized vaccine and for other trials. For the trial of the candidate that received the EUA, the sponsor would likely seek to unblind the trial and offer all participants the vaccine, including those who had previously received the placebo. This means that while the sponsor would have the results from the trial up to the EUA, it would have less continuing data about efficacy and adverse effects. For the trials of other vaccines, maintaining patient enrollment would be substantially harder once another vaccine had been authorized for use and became available. (Dr. Archana Chatterjee noted during the meeting that both of these concerns might be limited by the reality that doses of an authorized vaccine are likely to be in depressingly short supply for quite some time after authorization.)

These concerns would be less prevalent under an EA. The trials would continue—including for the full six months of safety data followup needed for an eventual vaccine approval, rather than the EUA’s two months—and there would be no authorized product driving the ending of either that product’s trial or the trials of other products. The official approval process, and the approval standard, would be the normal rigorous processes. Applying normal vaccine approval standards would hopefully help maintain public trust in the process—and even more importantly, it would help the agency actually get answers about vaccine safety and efficacy.

The first concern, in either case, should be to make sure that vaccine sponsors are able, and required, to collect adequate high-quality information about their candidates’ safety and efficacy. Though an EA seems less likely to kneecap ongoing trials and information collection because of the greater hurdles for patients to access products (including more robust informed consent), the risk exists for both EAs and EUAs, requiring careful management of ongoing trials so that they continue to collect useful data. When patients can easily access less-than-approved products, whether through EAs or EUAs, it becomes harder to enroll patients in clinical trials and to keep them there, degrading the information sponsors can collect. The case of convalescent plasma is a cautionary tale; while tens of thousands of patients have received plasma in an EA administered by the Mayo clinic, nominally associated with ongoing trials, these patients were rarely given plasma as part of randomized controlled trials—and the latest such RCT, conducted in India and published October 22, showed limited effectiveness.

Finally, the VRBPAC meeting is a laudable example of transparency and disclosure, including a range of views and frank discussion and open to public scrutiny. This is a very good thing. This is a time of decreased public trust of the FDA—and of science—by the public in general and minority communities in particular, who have been particularly hard hit by the virus. Making sure both to get the science right and to be seen getting the science right is absolutely crucial.

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post.

Excerpt from Masur & Ouellette's Free Patent Law Casebook (Forthcoming Summer 2021)

In January 2020, Jonathan Masur (Chicago Law) and I decided to write a free patent law casebook, which has turned out to be a rewarding pandemic project. As James Grimmelmann has documented, there are now many inexpensive and open-access IP and technology law casebooks, but none focused on patent law. Jonathan and I plan to pilot our casebook with our own patent law courses in spring 2021, and we will release the casebook in summer 2021 for free download online and in print on an at-cost, royalty-free basis through Amazon.

For a sample of what we've been working on, you can now download Patent Law: Cases, Problems, and Materials – Chapter II.A Novelty from SSRN. And in a win for future patent law students, instructors looking for a free patent casebook will soon have more than one option—Sarah Burstein, Sarah Rajec, and Andres Sawicki also have one in development, with an excerpt available here.

To help instructors use active-learning pedagogical strategies, our casebook emphasizes problems and practical exercises that ask students to apply patent doctrine to situations from recent cases. We are also attempting to make the book as concise and conceptually clear as possible, with graphical illustrations to summarize the doctrine and manageable reading assignments focused on the details of modern patent practice and policy.

We will provide adopting instructors with corresponding PowerPoint slides and a Teacher's Manual containing suggested answers to the practice problems and discussion questions. If you are teaching patent law in 2021–22 and are interested in seeing the Teacher's Manual, providing feedback on this chapter, or receiving further updates, please contact us at jmasur@uchicago.edu and ouellette@law.stanford.edu.

What is—and should be—the military’s role in COVID-19 research?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

A recent STAT News report found that Operation Warp Speed—the government’s Manhattan Project-style effort to quickly develop a COVID-19 vaccine—has substantial military involvement. Although it might initially seem counterintuitive to think of the virus as a military issue, the military’s involvement is part of a long history of government military spending on public health aims. What has been the role of military involvement and spending on preventing and treating diseases with pandemic potential? What’s different, if anything, for COVID? And what should policymakers and scholars be focused on going forward?

What role has the military previously played in R&D for infectious diseases?

As emphasized in a 2017 National Academies report, “global health security is national security,” and an infectious disease pandemic poses a particularly serious risk. Despite many such warnings, the United States still severely underinvested in pandemic preparedness; for example, a September 2019 report requested by the World Bank and WHO described “insufficient R&D investment and planning” for vaccines, antivirals, nonpharmaceutical interventions, and related innovations. But the military played an important and often overlooked role in the investments that were made. Americans have long supported massive military spending to prepare for and prevent national security threats, and some of this funding has been used for R&D. Indeed, across all areas of technology, the Department of Defense (DOD) provides more R&D funding than any other single agency, and DOD medical and health research expenditures are higher than those of any agency other than NIH (see Table 4 here). 

The military has played an important role in fighting infectious diseases throughout U.S. history, particularly when these diseases have threatened U.S. servicemembers. George Washington’s Continental Army created the first organized program to prevent smallpox after half of the 10,000 soldiers around Quebec caught the disease in 1776. Widespread yellow fever among U.S. troops during the Spanish-American War of 1898 spurred the U.S. Army to study the disease, determining that mosquitoes were responsible for its spread and laying the groundwork for a vaccine. After WWII, a 1953 respiratory disease outbreak among Army troops led researchers at the Walter Reed Army Institute of Research to identify a new adenovirus family and to create a vaccine a record-breaking three years later, in 1956.

More recently, military researchers have helped develop candidate vaccines for HIV and malaria, in addition to helping with development and distribution of HIV and malaria treatments. As Professor Ana Santos Rutschman has documented, the military also has played an important role in the efforts to develop Ebola and Zika vaccines. 

These efforts occur across the service branches as well as through the Defense Advanced Research Projects Agency (DARPA). Of the 238 sponsored projects currently listed on DARPA’s website, 15 are disease related, including a project with five teams of researchers focused on targeting pathogens in animals before they jump to humans and a project to produce protective antibodies for first responders to halt any outbreak within 60 days. These moonshot plans may sound like science fiction for now, but DARPA has successfully spurred past breakthroughs ranging from technology that formed the basis of the Internet (ARPANET) to the use of graphical user interfaces. DARPA’s creativity is not limited to the high-risk projects it funds; it has also experimented with novel methods of providing innovation funding, such as the $500,000 prize fund offered for predicting chikungunya epidemics across the Americas for a six-month period.

What role does the military play for the development of COVID-19 vaccines and therapies?

The military has been highly involved in the government’s response to COVID-19, most remarkably in Operation Warp Speed. Roughly two-thirds of the OWS leadership are employed by the DOD (the rest are mostly from the Department of Health and Human Services (HHS)).

To date, the military’s role in OWS has been focused on logistics. As we have noted before, manufacturing and distributing vaccines at very large scale brings substantial challenges; military resources have been involved in distributing raw production materials and in stockpiling the resulting products. Cold-chain logistics are especially difficult; Pfizer’s vaccine, for instance, must be stored in special freezers that maintain a temperature -80ºC. This presents particular challenges to getting the vaccine from manufacturers to patients, requiring a cold chain (perhaps even a particularly complex one) and administering not one but perhaps two doses for several of the leading candidates. The Army Corps of Engineers has also been particularly involved in tackling these issues, including maintenance of freezers. Aside from aliquots of the vaccine itself, distributing a COVID-19 vaccine will require ensuring there are enough associated supplies (such as syringes) to vaccinate the vast majority of Americans. The military may be well-suited to manage these vast logistical challenges in a way that other administrative agencies are not—especially with the assistance of the United States Public Health Service Commissioned Corps.

And of course, the military is also doing what you’d expect the military to do: it is providing security, both physical and cyber, to therapeutic and vaccine developers and manufacturers. It might seem surprising that the makers of products to stop devastating global pandemic would be the target of cyberattacks—but they are. Hacking, cyberattacks, and ransomware, including on clinical trials, are all increasing.

For Operation Warp Speed, the military is not doing is the science itself. Paul Mango, the deputy chief of staff for policy at HHS, and high in the OWS organizational chart, stated that “we are not conducting any science whatsoever inside the government to support Operation Warp Speed, none.”

Finally, in addition to its role in therapeutic development, the military has also been involved in the caring and triage of COVID patients, most famously, perhaps, in New York State at the height of the state’s outbreak. There, the Army Corps of Engineers converted the Javits Convention Center into a 2,000-bed hospital and the USNS Comfort, a naval hospital ship, took overflow patients—though by the time the 1,000-bed sailed from New York, it had treated only 186 patients.

What should policymakers be attuned to about military involvement in public health projects like these?

As policymakers consider when and how the military ought to be involved in the development and distribution of health care technologies, both for COVID-19 and beyond, they should consider both the strengths and weaknesses of military involvement.

One of the strengths of the military for innovation comes from its use of procurement policy to drive novel research and development. As we have discussed previously, pull incentives that provide certainty about the expected reward for a newly developed technology can be important in encouraging the development of innovation in a particular technological area. In the COVID-19 context, the United States has entered into a number of advance purchase agreements for vaccine candidates with the result of promoting early investment in vaccine manufacturing, but in other contexts where the potential market for a product is less certain, procurement agreements may provide sufficient incentives to invest in a product that would otherwise not have been developed.

At the same time, there are also reasons to be skeptical about the military’s involvement in the distribution of public health interventions. Given the diversity of settings into which the military is likely to be deployed, the military is unlikely to understand community dynamics on the ground everywhere, and will need to partner with local organizations—local public health officials and community organizations of various types—to build the trust needed to achieve its goals. Americans generally have more confidence in the military than in other U.S. institutions, so military involvement may help some communities overcome vaccine skepticism. But trust in the military likely varies by community, and in light of abuses against minority groups in particular, in some communities military involvement may increase rather than decrease skepticism.

When policymakers consider how the military might helpfully be involved in the development and distribution of new health care technologies, they ought to consider how the military should coordinate and cooperate with other agencies in doing so. In 2017, the Government Accountability Office recommended that DOD, HHS, and the Department of Homeland Security ought to use their “existing coordination mechanisms to improve their pandemic preparedness.” These agencies do have ongoing collaborative efforts, for instance, as the FDA and DOD collaborate on the development and approval of medical products intended for use in military personnel. But in the same way that Operation Warp Speed aims to orchestrate this coordination with leadership at the White House level, existing initiatives could benefit from greater centralized review and management, of the type articulated by Professors Stuart Benjamin and Arti Rai in their work. And for some efforts, like distributing vaccines requiring a complex cold chain to hundreds of millions of Americans, centralized and effective leadership at the top may make all the difference.

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post. 

Google v. Oracle and the search for an analogy

I had the pleasure of listening to the Supreme Court oral argument in near real-time from the comfort of my desk last Wednesday, one of the few positives to come out of this pandemic. There's a lot to say about it, but I won't do a full recap here or make any predictions. I'll likely follow-up after the opinion.

But one thing that struck me was the Court's struggle to find an analogy. I'm not the only person to point this out, of course, because it was palpable. Google used a filing cabinet as an analogy in its briefing, and that fell flat, never mentioned during argument. Other analogies, including essential facilities, football playbooks, qwerty keyboards, telephone switchboards, and grocery organizations had varying degrees of success in capturing the issues at play in the case.

It occurred to me that perhaps an appropriate analogy would have been a remote control - this is something that uses APIs, but that the Court could have wrapped its collective mind around. 

Consider a television set. It has an infrared detector that receives various a series of pulses that coincide with different functions: on, off, volume up, volume down, input selection, etc. The remote control has a list of these commands built into its memory. When the appropriate button is pressed, a lookup command finds the proper set of pulses, and sends them. I realize that this may be done via hardware, but not necessarily and even if so, the analogy still works to illustrate the consequences.

Let's assume now that this group of pulses took some creativity. There was a lot of work to make sure that the pulses didn't match other devices, and they could have been created any other way. But this collection of pulses is original, even highly so.

Now, along comes your cable box, and you want to turn the channel on cable, while powering on your TV and changing the TV's volume using a single remote. We've all been there, right? In order to do this, the cable box remote must include a collection of the pulses needed to do those things. Indeed, it will need the collection of pulses from every television manufacturer. Mind you, not every pulse will be needed. Cable box remotes won't have a "setup" button, for example. The universal remote can generate the compatible pulses in any number of ways, but the pulses will always be the same, or else the remote won't work.

What if the TV manufacturer says that its pulses are protected by copyright? It's not far-fetched. the pulses are 10011101001 - original expression. The longer the pulse, the more likely it is to be original. Should it be able to stop cable box manufacturers from including the list of pulses in its remote controls? Should it be able to stop competing televisions (or maybe sound bar makers) from including a list of those pulses so that a single volume change affects multiple devices at once?

Now this, I suggest, is an analogy that the Court can get its arms around. I am certain that every justice has worked a remote control, and a universal remote control. I would posit that most of them know how very different the world is when you have 5 different remote controls--one for each device--rather than a single universal remote.

This analogy, I submit, brings into focus the competing policy arguments. Google argues that competing remote control manufacturers must be able to have a list of all the pulse commands in their programming if they are to communicate with the TV.  It doesn't really matter how famous the TV is - if the TV maker gets to own the collection of pulses, then society is left with only one remote control possibility. Further, if other device makers cannot include the list of pulses to work with the TV's remote--and so only the TV maker can make devices that work with its remote--then consumers must use a different remote if they want to turn up the stereo or sound bar with a remote control.

Oracle, on the other hand, says that its collection of pulses, being original, is owned by the TV manufacturer, and as a result universal remotes and compatible sound bars are just riding its coattails. People are free to make up their own collection of pulses, but if that means nobody's remote control works with its TV's and nobody can used its remote control on competitor sound bars or televisions, that's just fine.

When put this way, I think the issue comes into stark resolution. 

• Was copyright meant to regulate remote control compatibility, even if the collection of pulses is original? I don't think so. 
• Is the sending of a message to turn up the volume from a remote control to a television a method of operating the television, not withstanding the originality of the pulse collection? Yes - the pulse is making the television do something. 
• Does allowing sound bar manufacturers (and even rival television manufacturers) to reuse the pulse collection so that they can respond to pulse commands from the original TV remote put the copyrightability of all the other original and creative functionality inside the original TV at risk?  No. APIs really are different. 
• Does this fit into copyright doctrine? Yes. As I noted in my amicus brief, the TV manufacturer is entitled to copyright protection in all of its code, including the collection of pulses. But when the pulses are reused to obtain a functional goal - namely remote to television compatibility, then we should filter them out. Whether you call it merger, idea/expression, or method of operation doesn't really matter. From a doctrinal point of view, we are saying that the commands necessary for one device/program to control another cannot be asserted as part of the copyright scheme. In Baker v. Selden, the court was clear that such use is allowed, even if copying of some expression is incident to it.
  

In sum, it is maddening to me how little mention Bateman v. Mnemonics has received in this case and its briefing. That case, decided at about the same time as Lotus v. Borlad 25 years ago, deals with nearly identical issues as this case, and quite easily disposes of the issues by filtering out common interface as function in an infringement analysis. 

As I note in my brief: "According to Westlaw, Bateman is cited in nearly 1/3 more cases than Lotus about (240:170), but only in about half as many secondary sources (about 450:950)." In other words, the straightforward application of filtration is not as sexy as ruling something is completely uncopyrightable as a method of operation. But it makes a whole lot more sense to courts, who have been using the methodology for nearly 25 years.

 

How are COVID-19 vaccine manufacturers aiming to encourage trust in the FDA’s approval process?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

What steps have vaccine manufacturers been taking to communicate with the public? 

Nothing has been usual about the COVID-19 vaccine development process so far, including the unprecedented steps taken by vaccine developers to communicate with the public. We think at least three facets of this strategy are worth noting.

First, vaccine developers have taken unprecedented public positions on the FDA approval process. On September 8, the CEOs of nine leading firms in the COVID-19 vaccine race—AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi—signed a pledge to “stand with science” in developing their vaccines. The stated goal is to “help ensure public confidence” in the approval process. The statement praises the FDA’s guidance for COVID-19 vaccines as based on “scientific and medical principles,” including the requirement for large, randomized, double-blind clinical trials across diverse populations. (The pledge came before the FDA announced that it planned to issue even tougher standards, although it now appears as if the White House has blocked the public release of those standards.) The most concrete pledge is to “[o]nly submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA” (emphasis added). This might do something to quell the alarm that followed FDA Commissioner Stephen Hahn’s statement that the agency might authorize a vaccine before Phase 3 trials are complete. The firms have not, however, necessarily bound themselves to the specific 50% efficacy requirement from the June 30 guidance. 

Second, although the “stand with science” pledge did not make any promises about disclosure of clinical trial design or data, some firms have independently released their trial protocols. Pfizer and Moderna published theirs on September 17, AstraZeneca followed suit on September 19, and Johnson & Johnson released theirs a few days later. As former FDA Commissioner Dr. Robert Califf has noted, current HHS regulations (effective January 2017) require this information to be disclosed eventually: the study protocol and statistical analysis plan must be disclosed on ClinicalTrials.gov along with clinical trial results, generally within 1 year after completing the trial. But enforcement of these requirements is spotty, and releasing trial protocols while studies are ongoing is unusual and demonstrates that the CEOs are taking public communication and trust seriously. Of course, the trial protocols are not designed for lay audiences—each one contains over 100 pages of technical details—but publishing them may help shore up expert confidence. Experts such as Dr. Eric Topol have been combing through the protocols to summarize and compare them in ways accessible to those without a background in study design.

Third, vaccine developers have taken unusual steps to communicate with Americans more directly. For example, Pfizer CEO Albert Bourla has recently gone on shows like the Today show and Face the Nation, and Moderna CEO Stephen Hoge appeared on CBS Evening News. Both have provided information about when we will realistically know whether their vaccines work—Bourla expects results by the end of October, Hoge thinks November or December—and have admirably (and correctly) noted that this does not mean that distribution would start then. Both have also tried to restore public confidence in the process, including by promoting their “stand with science” pledge and protocol disclosure. Hoge acknowledged that “one of the biggest challenges we have” is “building confidence in the vaccine” while “mak[ing] sure we’re making the right scientific choices and we’re presenting honestly the uncertainties around those choices.”

What’s motivating these unusual actions from pharmaceutical companies?

As noted earlier, these actions are unusual; pharmaceutical companies don’t normally engage in this sort of public-facing transparency while studies are ongoing. There are at least three possible and related reasons we might be seeing such behavior here. 

First, and perhaps most important, vaccine makers and the pharmaceutical industry—really, the entire health-care industry—depend on trust. Patients need to trust that drugs will be safe and effective, or they won’t buy them. The biggest guarantor of that trust is the FDA, which puts its seal of approval on products by allowing them into the marketplace. A high-profile failure here, where a drug company marketed a vaccine that didn’t work or wasn’t safe and the FDA permitted its marketing, would be a colossal blow to trust in the pharmaceutical industry (and a terrible result for society as well). This would ultimately be bad for their bottom lines. And so, while pharmaceutical companies want patients and doctors to trust them, they really want patients to trust the FDA, which provides—or provided—a high baseline level of trust in the drug approval system as a whole.

There are already signs of decreasing trust in the FDA and other government agencies. This mistrust is especially prevalent among minority communities which have been hardest hit by COVID-19—in part because they’ve been the subject of abuses in both research and treatment. Some medical professionals are following suit; the National Medical Association, an organization of Black physicians, has created its own independent task force to vet COVID-19 vaccines. And drug companies have been responding to this minority distrust as well; Moderna announced that it is slowing enrollment in its vaccine trial to ensure that it can enroll sufficient minority patients.

Second, and relatedly, at least some pharmaceutical companies benefit competitively from having a stringent standard for approval. The FDA operates as a gatekeeper to the pharmaceutical market, creating barriers to entry. As Professor Rebecca S. Eisenberg has written, the FDA’s high approval standards force firms to generate high-quality, costly information about safety and efficacy. This costly endeavor is something which large, established players like Pfizer and AstraZeneca can undertake, but is harder for smaller market upstarts (although this argument likely applies with less force to large upstarts like Moderna). For large incumbent firms, maintaining FDA’s high standards isn’t just about keeping trust in the system as a whole—it’s also about keeping their competitive position in the pharmaceutical industry. Even for fast-developing COVID-19 vaccines, there is likely to be competition, and to the extent that high entry barriers are more surmountable by large firms than by others, those large firms have an incentive to keep the barriers high.

Third and finally, the public, and public funders in particular, have been unusually deeply involved in the development of COVID-19 vaccines, whether in terms of basic research, manufacturing assistance, or advance commitments to purchase final products. To be sure, the companies have made enormous investments of private funding and are the ones conducting most of the clinical trials, but the public has been present throughout. Given this robust public involvement, there have been calls and even FOIA requests for more information about the process. To the extent that the relevant information is likely to come out one way or another, proactive disclosure by companies may preempt other avenues of getting the information—and in such a way that the drug companies get the reputational benefit of disclosing on their own. 

How can we encourage the release of information in order to benefit the public?

Developers’ engagement with the public and their efforts at improving transparency in the development process are a good thing. To researchers and the public alike, the particulars about therapeutic and vaccine development have long been hidden in black boxes. Encouraging transparency in their development allows the public to better understand how an industry critical to its health and well-being operates; it also helps researchers better understand important aspects of their work, like decisional inflection points, cost, and pricing. Moreover, in a political climate where trust of public institutions has eroded into dust, developer-side transparency should give us more confidence in the capacity for industry self-governance. Commitments by legacy therapeutic developer CEOs suggests that they understand that they’re stewards of such institutions. But how could such commitments be improved? 

With respect to COVID-19 vaccines, developers could be encouraged to immediately release any clinical trial data once a new phase is completed. Typically, there’s a lag—sometimes a long lag—between the completion and reporting of each phase to the FDA and a “publication summary” of that data for public consumption. This lag exists principally because the FDA treats the particulars of clinical trial data as confidential business information (CBI). Immediate publication of COVID-19 trial data will give everyone a better sense of when a COVID-19 vaccine is likely to arrive and what the ultimate efficacy rate is.

This could be accomplished in several ways. To the extent developer CEOs are, indeed, doing this public road show to shore up public confidence, interviewers could ask them to publicly state that they will release such information earlier than usual. Similarly, scientific journals could make similar commitments about publishing data summaries—namely, that publication won’t happen unless the underlying data has previously been released. (In some sense, this turns the business of publication on its head; in another, it’s no different these days from medRxiv.) In addition, while early data release seems like a wonky issue, it presents an opportunity for public buy-in. Where public confidence in public health policies are low or borderline, trusted actors—whether it is a medical journalist like Sanjay Gupta or a celebrity like Paul Rudd—can use the released evidence to help encourage public participation and uptake.

More broadly, these opportunities for transparency can—and should—extend beyond COVID-19 vaccine development. As noted above, the FDA could do more to enforce existing requirements to disclose clinical trial protocols and data within a year of trial completion. The FDA had, at one point, committed itself to additional reforms regarding its handling of clinical trial data and CBI, although it backtracked soon afterwards. While the FDA has a less than ideal transparency policy on clinical trial data, there are good blueprints out there for making it better within much of the agency’s already existing authority. In addition, some recent regulatory changes to the development process itself “have the potential to improve the efficiency and quality of clinical research by allowing investigators and companies to learn from successes and failures of similar products.” Promoting efficiency in development through transparency is not as radical as it sounds; the European Medicines Agency does far more than the U.S. does regarding transparency, which helps ultimately promote both drug development and public confidence in the process. And if there’s one policy lesson for the U.S. to heed well, it’s to look to our international allies for better strategies to combat the virus.

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post.