The Hidden System of Legal Kickbacks Shaping the U.S. Prescription Drug Market

In the United States, as in most other countries, it is illegal for pharmaceutical companies to bribe doctors or hospitals to prescribe their products. Those who get caught engaging in this sort of corruption can suffer severe penalties. For example, in 2020, the pharmaceutical giant Novartis agreed to pay the U.S. government almost $700 million to settle a case involving allegations that the company had violated the federal Anti-Kickback statute by offering “cash payments, recreational outings, lavish meals, and expensive alcohol” to doctors to induce them to prescribe Novartis drugs. Yet when pharmaceutical companies offer financial inducements worth billions of dollars to Pharmacy Benefit Managers (PBMs)—not the meager thousands spent on doctors—to promote use of their drugs, the conduct is entirely legal.

What, you may ask, are PBMs? Good question. Most laypeople outside the health care field are unfamiliar with PBMs, and may not even know they exist. But PBM’s play a crucial, if underappreciated and extremely complex role in determining prescription drug prices and insurance coverage decisions. Simplifying somewhat, PBMs’ primary function is to manage insurance companies’ prescription drug plans, a role that includes, among other things, negotiating with drug companies to determine which drugs insurance will cover, and which will be favored. Given that just three PBMs control over 80% of the prescription drug market, PBMs can have an enormous effect on pharmaceutical sales, as drugs that lack insurance coverage are significantly less attractive to consumers than those with coverage. Additionally, PBMs also reimburse pharmacies on behalf of insurance providers for the costs of filling beneficiaries’ prescriptions.

In short, PBMs, which stand in between many of the transactions in the pharmaceutical supply chain, play a major role determining the prices paid by insurers, pharmacies, and patients for prescription drugs. And although kickbacks to doctors, hospitals, insurance companies, and other actors in the system are strictly prohibited, drug companies can and do take advantage PBMs’ complex payment structures to discreetly offer financial inducements in order to gain PBMs’ favor during insurance coverage determinations. There are two main ways in which this de facto bribery occurs: Continue reading

The FDA Drug Approval Process Has Problems—But It Is Not Corrupt

Is the US drug approval process corrupt? Many critics say that it is, leveling the charged rhetoric of corruption at the Food and Drug Administration (FDA) (see, for example, here, here, and here). Yet there have been few, if any, credible allegations of illegal bribery or the exchange of quid pro quo benefits in relation to FDA drug approvals. Rather, when critics speak of “corruption” at the FDA, they are alluding to a perhaps all-too-cozy relationship between the FDA and the pharmaceutical companies it regulates. That is indeed a source of concern: Big business likely has too much sway in Washington, D.C. on a whole range of issues, and the FDA is not immune to the powerful influence of powerful lobbies like Big Pharma. Yet the casual deployment of the rhetoric of “corruption” in this context, though offering attractive click-bait, is both misleading and potentially counterproductive. Continue reading

New Podcast, Featuring Sarah Steingrüber

A new episode of KickBack: The Global Anticorruption Podcast is now available. In this week’s episode, I interview Sarah Steingrüber, an independent consultant on corruption and public health issues. Among her other activities in this area, she currently serves as the global health lead for the CurbingCorruption web platform, and was the co-author of the U4 Anti-Corruption Resource Centre’s report on Corruption in the Time of COVID-19: A Double-Threat for Low Income Countries. Much of our conversation naturally focuses on how corruption and related issues may intersect with the coronavirus pandemic and its response, in particular (1) misappropriation of relief spending, and (2) how some corrupt leaders may use the coronavirus pandemic as a pretext to eliminate checks and oversight. A central tension we discuss is how the urgency of emergency situations affects the sorts of measures that are appropriate, and draws on lessons from prior health crises such as the Ebola outbreak in West African in 2013-2016. We then discuss other more general issues related to corruption and health, such as how the monetization and privatization of health may contribute to undue private influence on decision-making processes in the health sector.

You can find this episode here. You can also find both this episode and an archive of prior episodes at the following locations:

KickBack is a collaborative effort between GAB and the ICRN. If you like it, please subscribe/follow, and tell all your friends! And if you have suggestions for voices you’d like to hear on the podcast, just send me a message and let me know.

Guest Post: More Transparency Is Needed to Fight Grand Corruption in the Pharmaceutical Sector

Today’s guest post is from Till Bruckner, the founder of TranspariMED:

In the pharmaceutical sector, public agencies are routinely handing over billions in public money to private companies for products whose value they cannot accurately assess, because the vendors control the flow of information generated by clinical trials. (Even the purchasing price is often kept secret, but that is another story.) If we observed this sort of opacity in the public procurement sector, it would immediately raise red flags. If public contractors were taking billions from governments in exchange for products of dubious quality that the governments cannot assess, the anticorruption community would be–rightly–up in arms. But for the pharmaceutical industry, this is business as usual.

Consider, as one particularly egregious example, what can only be described as an $18 billion heist of public money by a pharma company. In 2006, governments around the world began stockpiling Tamiflu, an anti-retroviral drug, due to fears that outbreaks of bird flu (and later swine flu) could turn into a lethal global pandemic. The evidence available at the time suggested that the drug was safe and effective at reducing the symptoms of influenza. In total, 96 counties accumulated enough Tamiflu to treat 350 million people. Then, in 2009, a doctor noticed that the results of eight clinical trials of Tamiflu were missing from the public record. (Worldwide, around half of all clinical trials have never reported their results.) After a struggle lasting four years, independent scientists finally got the company to turn over the relevant data from these trials—and concluded that the drug did little, if anything, to help patients.

This example is especially egregious, but it is not otherwise exceptional. Amazingly, comprehensive information on the safety and effectiveness of drugs is not only inaccessible to independent scientists, but also to government agencies. When a drug company applies for a marketing license, it has to submit detailed documentation from every relevant trial to regulatory agencies such as the U.S. Food and Drug Administration (FDA). Regulators review these submissions, called Clinical Study Reports (CSRs) – and then promptly lock them away in their confidential archives. This is especially frustrating for scientists working for health technology agencies, who are tasked with assessing the cost-effectiveness of different drugs but are often unable to access CSRs. To date, only the European Medicines Agency systematically releases (some) CSRs.

Politicians have tried to bring transparency into the sector, but the laws they pass often remain unenforced. In the United States, the 2007 FDA Amendment Act made it compulsory for companies and universities to publish the summary results of some clinical trials on public registries. (Summary results are a kind of “executive summary” of a clinical trial; they are far shorter and less detailed than CSRs, but still better than nothing). In 2015, an investigation by STAT News found that pharmaceutical companies routinely violated the law. The law stipulates a fine of up to $10,000 for every day a result is overdue. In theory, Big Pharma has already racked up over $25 billion in fines. In practice, the FDA has yet to collect a single cent. In the European Union, a similar regulation exists, but there too it remains unenforced by national agencies. In Britain, a 2013 parliamentary inquiry called for greater transparency, but its recommendations were largely ignored.

Last December, a coalition of four health integrity organisations issuing a wake-up call for governments to finally get serious about clinical trial transparency. Transparency International Pharmaceuticals & Healthcare (PHP), TranspariMED, Cochrane, and the Collaboration for Research Integrity and Transparency (CRIT) released a study that documents in detail how opacity in the sector harms patients, prevents public health agencies from making informed decisions, wastes public health funds, slows down medical progress, and exposes shareholders to substantial risks. The study also shows that clinical trials can be made significantly more transparent without introducing new legislation. Public research funders could demand that grantees report the results of publicly funded trials. Regulators could make continued market access conditional on companies agreeing to make CSRs publicly available. And in many cases, simply enforcing the rules already on the book could make a huge difference – and the costs of enforcement could easily be covered by imposing fines for noncompliance.

The medical research community has long called for greater transparency in medical research. The AllTrials campaign, which calls for all clinical trials to be registered and fully reported, has attracted the support of over 700 groups, including the American Medical Association and dozens of patient groups, and TranspariMED is currently building a broader coalition to push for greater transparency in the sector. It’s high time for the wider anticorruption community to join the fray.

Guest Post: Catalyzing Anticorruption Efforts in the Pharmaceutical Sector–Collaboration Is Key

Michael Petkov, Programme Officer for Transparency International’s Pharmaceuticals & Healthcare Programme, contributes the following guest post:

It will come as no surprise to readers of this blog that the pharmaceutical sector has extensive corruption risks: the sector is extremely complex, with multiple actors, high-value products, large-volume contracts, and a high degree of information asymmetry. But despite these well-known risk factors many actors in the pharma sector are failing to produce and enforce adequate anticorruption policies. Key decision-makers in the pharma sector frequently do not perceive corruption as an important issue and often do not display a genuine commitment to anticorruption efforts.

A recent paper published by Transparency International and the Leslie Dan Faculty of Pharmacy at the University of Toronto identifies several overarching challenges that are hampering efforts to minimize corruption in the pharma sector, and posits key areas for action including the importance of harnessing technology to minimize corruption vulnerabilities and of increasing the monitoring, enforcement, and sanctions of actors. Because of the complexity of the sector, collaboration is essential to making progress on all of these fronts. After all, a key difficulty for tackling corruption in the pharmaceutical sector is the fact that the medicine chain stretches across national borders. It is encouraging that governments came together at the London Anti-Corruption Summit and recognized the need for national institutions to share relevant information with their peers in other countries. Similarly, multi-stakeholder initiatives such as the European Healthcare Fraud and Corruption Network are excellent opportunities for all types of actors to come together, share information, and collaborate with others to take action.

There are two other ways in which greater collaboration is critical for making progress on the fight against corruption in the pharma sector: Continue reading

Fact-Checking the FCPA Scaremongers

In my last post, I made a disparaging in-passing reference to assertions, by some critics of the US Foreign Corrupt Practices Act (FCPA), that companies could get in FCPA trouble if they do things like buy a foreign government official a cup of coffee, take her to a reasonably-priced business meal, cover her taxi fare, etc. In my view, that’s just wrong, both because the US government would not bring such a case, and because the FCPA wouldn’t cover such isolated, modest benefits. The reason, as the DOJ/SEC FCPA Resource Guide explains, is that such benefits, without more, would not be offered “corruptly”–that is, with the wrongful intent of inducing the official to misuse her official position). I described those who suggest that the FCPA would criminalize such minor benefits as “FCPA scaremongers.”

My use of that the term “scaremonger” seems to have touched a nerve with Professor Mike Koehler–the self-described “FCPA Professor”–who had this to say in his comment my earlier post:

Scaremongering? Recent FCPA enforcement action have included allegations about flowers, cigarettes, karaoke bars, and golf in the morning and beer drinking in the evening.

I responded by asking Professor Koehler to identify the most ridiculous example of an actual FCPA settlement in which a trivial benefit was the sole basis of the enforcement action, as opposed to a small part of a larger scheme to corrupt government officials into misusing their authority. Professor Koehler answered:

The following is a factual statement: recent FCPA enforcement action have included allegations about flowers, cigarettes, karaoke bars, and golf in the morning and beer drinking in the evening.

I take the position that the DOJ/SEC include such allegations in FCPA enforcement actions for a reason and not just to practice their typing skills.

I again asked for an example. Professor Koehler’s response was to send, not the name of any individual case, but rather the links to the DOJ and SEC sites with all enforcement documents, suggesting that I could go through them myself to find “numerous examples of inconsequential things of value” included in the government allegations. He also referred to “several speeches” by SEC enforcement chief Andrew Ceresney (I actually think it’s one speech, given by Mr. Ceresney in November 2015) that supposedly acknowledged the government’s sweeping view of FCPA-prohibited conduct.

Having tried unsuccessfully to get Professor Koehler to point me to a specific example, I did a bit of digging on my own to see if I could find out if it’s really true that the DOJ and/or SEC have brought FCPA enforcement actions in cases that involve nothing more than “flowers, cigarettes, karaoke bars, and golf in the morning and beer drinking in the evening.” What I found makes me even more confident that I was fully justified in my use of the term “FCPA Scaremongers,” with Professor Koehler as perhaps the FCPA Scaremonger-in-Chief. Here are the cases to which I’m fairly sure Professor Koehler was referring: Continue reading