Tag Archives: United States

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

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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 →

FinCEN’s Beneficial Ownership Proposal: Invitation to Evasion

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GAB welcomes this guest post by Gary Kalman, Executive Director of Transparency International U.S.

The Financial Crimes Enforcement Network (“FinCEN”), the bureau charged with implementing our nation’s anti-money laundering laws, is underfunded. They do not have enough staff and significant staff turnover has left the bureau with less institutional knowledge and memory. On top of this, the agency has an Acting rather than permanent Director, undercutting its leaders’ ability to set a clear vision and direction for the bureau.

None of that, however, can explain the agency’s remarkable lapse in judgement in publishing  this proposal to collect beneficial ownership information from U.S. companies.

Let me explain.

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

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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 →

Making Corruption a National Security Issue: How Will it Change Enforcement Dynamics?

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Today’s Guest post is by Nedim Hogic. Nedim advises clients in the private and public sector on environmental, social, and governance issues. Author of many articles on corruption, international law, and the rule of law and development, he is currently writing a book on judicial anti-corruption campaigns.

Since becoming an important policy goal in the 1990s, global anticorruption efforts have gone through three phases. In the first, anti-corruption policies were considered important for economic development, driven by the belief that successful anticorruption programs would make global borrowing and spending and financial aid more efficient. In the second, spanning the first two decades of this century, it was central to the protection of the rule of law and democracy.

The current phase, and particularly that part denominated “kleptocracy,” is animated by the threat it poses to global security. The Biden Administration’s national security strategy, which followed its memorandum calling the fight against corruption a core U.S. security interest, is not the first American or indeed international document to suggest corruption is a national security threat. But it is the first to state the premise clearly and straightforwardly, thus marking a sharp change in thinking about transnational corruption. Indeed, in my view the change is significant enough to be labelled a paradigm shift.

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When and Why Do Whistleblower Reward Programs Succeed?

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It is often difficult to expose and unravel corruption schemes without the cooperation of insiders. Yet would-be whistleblowers are frequently deterred from making disclosures due to the personal and professional risks of doing so. One increasingly popular way that countries are addressing this problem is through whistleblower reward programs. While such programs vary widely in their specifics, most operate under the same basic framework, offering a whistleblower who discloses material nonpublic information that leads to an enforcement action a monetary reward—typically, a percentage of the fines imposed on the liable parties—as an inducement to come forward.

In the United States, which pioneered this mechanism, whistleblower reward programs have seen broad success. Between 1986 and 2020, whistleblower cases under the False Claims Act (FCA) brought in $46.5 billion in penalties, with whistleblowers receiving $7.8 billion in rewards. And this is only under the FCA—other U.S. whistleblower reward programs have also led to the recovery of significant additional sums. For example, under the whistleblower program created by the Dodd-Frank Act, which was created in 2011, whistleblower tips have contributed to at least $2 billion in financial remedies for violations of the securities laws, with over $720 million awarded to whistleblowers. The success of whistleblower reward programs in the United States has inspired similar programs in several other countries, including South Korea, Canada, Nigeria, Ghana, Hungary, and Kenya. But not all of these programs have been similarly successful. For example, in Ghana, the first country in Africa to introduce a whistleblower reward program, no rewards are known to have been issued—in fact, few have made use of the Ghanaian Whistleblower Act’s provisions at all.

What factors help explain when a whistleblower reward program will work as intended? There is no easy or simple answer—the issue is complex, and the effect of any given program depends in part on details of the program’s design, including the prerequisites for receiving a reward and the scope of the program, as well as the country’s culture around whistleblowing. That said, two factors stand out as key indicators of whether a whistleblower reward program will succeed in encouraging substantial numbers of whistleblowers to come forward:

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Vote Buying: Why the Secret Ballot Isn’t Enough

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Vote buying is an especially pernicious form of corruption, as it threatens to undermine the democratic process, thereby enabling other forms of corruption and misgovernance. One of the most important institutional mechanisms designed to inhibit vote buying is the secret ballot. First adopted in Australia in 1856, the secret ballot is now the norm in liberal democracies. Yet vote buying remains a problem in many such democracies, especially in the developing world (see here, here, and here). To better understand how to fight this form of corruption, it is important to understand why the secret ballot is not sufficient to eliminate the problem. While different communities face distinct challenges, there are several common mechanisms that allow vote buying to persist, even when it is impossible for the vote-buying politicians to verify that the voters they bribed actually voted the way that they had promised.

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Foreign Law Enforcement Agencies to Get U.S. Beneficial Ownership Information

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The cause of financial transparency just recovered some of the ground recently lost when the European Court of Justice struck down the EU directive on public access to corporate ownership data. Last Friday the U.S. Financial Crimes Enforcement Network (FinCEN) published draft regulations prescribing how certain limited — but quite important – members of the public can obtain information on the actual, beneficial owners of U.S. corporations.

The privileged group consists of law enforcement personnel. And significantly for the global fight against corruption, they include those from non-American as well as American agencies.

The rules for domestic agencies are straightforward, those for non-U.S. authorities less so as they incorporate the conditions Congress put on foreign agencies’ access. The request must be for a law enforcement purpose or national security or intelligence activity; it must be transmitted through a U.S. law enforcement intermediary, and the requesting government must have either an “applicable treaty” with the U.S. or else be a “trusted foreign government.”

For corruption-related cases these conditions would appear to pose no real hurdle. Moreover, in fleshing them out, FinCEN was attentive to foreign authorities’ needs. FinCEN defines “law enforcement purpose,” for example, to include civil forfeiture actions.

Between the diversity of foreign laws and the many types of agreements foreign partners have with U.S. counterparts, however, the agency cautions the draft regulations might still interfere with current arrangements. Anticorruption agencies, prosecution services, and other non-U.S. authorities should therefore examine the draft carefully, ideally in consultation with the U.S. agency or agencies with which they work. Comments are due by February 23.

I see one potential issue and have one question about the proposed rules.

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Risky Wagers: How Lack of Oversight Increases the Odds of Corruption in Sports Gambling

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Thanks to the internet, sports gambling—once limited to smoky back rooms and local bookies—has rapidly expanded, and this expansion has fueled growing concerns over the integrity of professional sports. Sports gambling has long been intertwined with sports-related corruption, but the sheer number of gambling transactions made possible by the advent of online betting (through both legal and illegal websites) substantially increases the likelihood that bribery or match-fixing will be used to ensure a “winning bet.”

National regulatory approaches have not kept up with the heighted risks. The United States, for example, continues to rely on outdated regulatory regimes and ill-defined responsibilities shared between state regulators, federal regulators, and professional sports leagues. As more and more states move to legalize sports gambling, the US is in urgent need of a centralized authority that possesses the necessary incentives and requisite capabilities to properly regulate this burgeoning industry.

To see why reform is needed, consider each of the three main actors (or sets of actors) that have some responsibility to deal with the integrity threats posed by online sports gambling in the U.S.: state governments, the federal government, and the professional leagues: Continue reading →

Responding to the ABA’s Objections to the ENABLERS Act

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In a rare moment of bipartisanship, the U.S. Congress is on the cusp of adopting a significant piece of anticorruption legislation: the ENABLERS Act.  The ENABLERS Act is targeted at closing loopholes in the American financial services system that have allowed corrupt foreign actors to use “gatekeeper” entities like law firms, trusts, payment processors, and accounting firms to launder billions of dollars through offshore accounts. The proposed legislation, which has been attached to the FY2023 National Defense Authorization Act (NDAA), would expand the definition of “financial institution” in the current Bank Secrecy Act (BSA) to cover more gatekeeper entities like those mentioned above, and would require these financial services-adjacent entities to institute anti-money laundering (AML) systems, comply with Know Your Client (KYC) regulations, and file suspicious activity reports (SARs) with the Treasury Department. 

The ENABLERS Act, discussed previously on this blog, has received widespread support in both the House and Senate, but some influential interest groups remain opposed. Notably, the American Bar Association (ABA) has objected to the inclusion of law firms among the entities that the ENABLERS Act would subject to the BSA’s AML rules. The ABA’s chief objections are that the ENABLERS Act—especially the requirement that law firms would be required to file SARs—would undercut attorney-client confidentiality and the right to effective counsel and would inappropriately interfere with state judicial regulation of the legal profession.

While the ABA is correct in emphasizing the fundamental principle that everyone is entitled to legal representation, and that lawyers have duties of confidentiality, loyalty, and zealous advocacy to their clients, the ABA’s objections to the ENABLERS Act are overstated. Upon closer inspection, the ENABLERS Act does not ask lawyers to do more than the ethical regime that governs the legal profession already requires or permits.

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Twentieth International Anticorruption Conference December 6-10 in Washington, D.C.

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One mark of the progress in putting the fight against corruption on the global agenda is the size and scope of this year’s International Anticorruption Conference. The first one drew less that 200 people, mostly law enforcement personnel from the United States and 12 other nations (here). Organizers expect this year’s — December 6 through 12 in Washington — to attract more than 2,000 representatives of government, civil society, and the private sector from 135+ nations with many more attending virtually.

Jointly organized by Transparency International and the the U.S. government, speakers include: Delia Ferreiro, Chair of the Transparency International Board of Directors; David Malpass, President of the World Bank; Adesina Akinwumi, President of the African Development Bank; Ghada Waly, Executive Director of the United Nations Office on Drugs and Crime; Samantha Power, Administrator for the United States Agency for International Development; the heads of the Open Government Partnership, the Financial Action Task Force, CIVICS, and the chief executives of several multinational corporations.

The theme of this year’s conference is “Uprooting Corruption, Defending Democratic Values.” Plenary sessions will address the “grand issues:” global security, defending the defenders, kleptocracy and illicit finance.  There will be over 60 workshops, and multiple special thematic events and social gatherings.

More on who is coming, workshop and thematic events, and how to register is here.