Ending Drug Price Gouging: A Regulatory Framework for Pricing of Medicine Innovation

Yves here. As much as the post below pursues a worthy goal, which is to push back against Big Pharma’s grotesque pricing abuses in the US, it is frustrating to see the authors feel they have to dignify the drug industry’s ludicrous claims that it needs to overcharge Americans “because innovation.”

It takes only a cursory review of facts to establish that US drug companies are not in the business of innovation and should not be allowed to harm American’s health by effectively denying them treatment via overpriced medications, insulin being a glaring example.

Lack of bona fide innovations. A partner at one of the handful of boutique law firms that did FDA/intellectual property work (some of her partners were former FDA commissioners; she had written the NIH’s first license of its intellectual property and over 80% of her language remained in contemporary licenses) told me many years ago that 88% of recent “new drug applications” were not for what the public would think were new drugs at all but for minor reformulations of existing drugs to add to patent life, such as creating an “extended release” once every 24 hour pill in addition to the old “three times a day” version.

Grotesque expenditures on marketing. Big pharma spends more on marketing than on R&D. How many industries have margins so fat that they justify in-person selling to small businessmen (as in doctors) and seemingly unending TV ads?

Heavily government subsidized basic and applied research. Most analyses look only at NIH funding and ignore other sources, which are also substantial, as well as tax incentives. Due to the state of internet search, I cannot find the source again, but one paper that took a comprehensive look at drug company subsidies found that it approached 30% of total R&D.

Creative accounting. Big pharma likes to tout its high level of R&D spending. However, most major pharma companies also sell OTC products. For instance, Pfizer sells Chapstik and Emergen-C. A colleague who worked at Bristol Myers back in the day when it owned Clairol, which is a staggeringly profitable business (hair color is made for pennies a box and sells for dollars a box), said that every overhead (including expenditures that were debatable as overheads) to Clairol to make the drug business look better and increase its apparent R&D spending relative to other expenses. I am sure that practice is widespread.

Low productivity R&D expenditures. Just because you throw money at “innovation” does not necessarily mean you get a lot to show for it. From a 2019 INET post:

But just because a company spends billions of dollars on R&D does not mean that this spending is productive. Öner Tulum’s in-depth analyses of specific pharmaceutical companies show that those corporations that are the most financialized in terms of distributions to shareholders are those whose spending on R&D is least productive per dollar spent.[6] Among these companies are Merck and Pfizer, whose R&D expenditures ranked them #9 and #10 in that department among all U.S. companies in 2018. These companies have grown large by acquiring “blockbuster” drugs that other companies have developed and then milking them for revenues over their remaining patent lives.[7] Meanwhile, notwithstanding all of their R&D spending, these companies do little in the way of internal drug development.

Spending on buybacks rather than reinvesting. The companies’ actions belie their poor-mouthing about innovation. From the same INET paper:

…distributions to shareholders [by the 18 largest US pharmaceutical companies] were 14% greater than the $544 billion that these companies devoted to R&D spending. The 18 pharmaceutical companies comprised 3.9% of the 466 companies from all industrial sectors, but they distributed 8.5% of all buybacks and 9.3% of all dividends. Buybacks and dividends amounted to 106% of the 18 companies’ combined profits, compared with 92% for all 466 companies in the 2009-2018 sample. Big pharmaceutical companies are big on doing distributions to shareholders.

Now to the current article.

By Rosie Collington Junior Researcher, Academic-Industry Research Network and William Lazonick, Professor of Economics, University of Massachusetts Lowell
President, The Academic-Industry Research Network. Originally published at the Institute for New Economic Thinking website

Drug Prices and Corporate Profits

The United States is unique in its failure to regulate pharmaceutical drug prices. The nation’s households pay on average over two and a half times as much for prescription medicines as their counterparts in other OECD countries. In 2018, pharmaceutical spending totaled $1,229 per capita in the United States, compared to, for example, $884 in Germany and $865 in Canada. Congressional complaints that U.S. drug companies engage in price gouging go back to the 1980s, but Americans are still waiting for significant legislative remedies.

The unregulated monopoly over the determination of prices that U.S. society currently grants the pharmaceutical industry has devastating consequences for many U.S. households, particularly those that are uninsured. Despite an overall reduction in the number of uninsured Americans following the introduction in 2010 of the Affordable Care Act, in 2019 26.1 million people—eight percent of the population—were not covered by an insurance plan at any point during the year.

The Biden administration has pledged to make drug prices more affordable as part of its signature Build Back Better agenda. Biden’s plan includes three key policy reforms: i) permitting Medicare to negotiate with manufacturers prices of a list of specific drugs; ii) penalizing companies that raise prices faster than inflation for Medicare Parts B and D; and iii) introducing price caps on patients’ out-of-pocket costs. Even if these reforms are enacted, they will have been watered down to win the votes of some Congressional centrists. Gone, for example, will be the original proposal to empower the government to negotiate the list prices of the 250 single-sourcebrand-name drugs on which Americans spend the most. These drugs include insulin analogs, which saw price increases of 252 percent between 2008 and 2017 across the three manufacturers that dominate the U.S. market.

Those challenging the proposed reforms have argued that federal intervention to reduce drug prices would adversely affect investment in drug innovation because companies would have less profits to fund drug development. That high profits are needed to finance drug investment is a well-known pharmaceutical industry claim—and it is no coincidence that a number of the Congressional Democrats who have resisted drug-price reform have been among the largest recipients of campaign donations from the pharmaceutical industry.

We define drug innovation as the generation of a medicine that is both higher quality (safer and more effective) and lower cost (more accessible and affordable) than those previously available for a specific medical condition. As we show in our new Institute for New Economic Thinking working paper, “Pricing for Medicine Innovation,” the argument that drug companies need profits on existing products to finance the next round of innovative medicines may have merit in an economic system that relies on business corporations to develop, manufacture, and deliver drugs. But that is precisely why the public requires regulation of drug prices: Business corporations should not unilaterally decide how high drug prices should be to generate the amount of profits that innovation purportedly requires.

Drug-price regulation is needed both to set the amount of profits that are potentially available for corporate reinvestment in innovation and to ensure that a pharmaceutical company actually allocates those profits to the development, manufacture, and delivery of innovative medicines. Given the investments by government agencies and scientific communities in drug development that precede and make possible value added by an innovative pharmaceutical company, it makes no sense to leave the setting of the product price solely to the business firms that market, insure, and sell the drug. Working on behalf of American households, a government agency, which we would call the Pricing for Medical Innovation (PMI) regulator, must be directly involved in the negotiations that set the drug price.

Unregulated Drug Pricing in a Financialized Industry

Research has shown that the status quo absence of pricing regulation in the United States is not associated with higher investments in research and development but rather with value-extractive financial practices that undermine innovation. As egregious examples of the predatory value extraction that occurs throughout the U.S. corporate economy, major U.S. pharmaceutical companies have been allocating their profits to cash dividends and stock buybacks at the expense of drug innovation. These same companies price gouge patients for the sake of higher profits that can be used to pump up stock yields. The stock-based compensation of U.S. corporate executives incentivizes this anti-innovation behavior, as does pressure for strategic control over corporate resource allocation applied by hedge-fund activists.

Especially in the current unregulated environment populated by financialized drug companies, the Biden administration needs to be guided by a “theory of innovative enterprise” as it seeks to balance patient access to affordable drugs with its stated objective of “mak[ing] sure that market incentives foster scientific innovation to promote better health care and improve health.” Rooted in the theory of innovative enterprise developed by Lazonick and colleagues, our INET working paper outlines how informed drug-price regulation can support the funding of innovative medicines by business corporations while enabling equitable financial returns to those parties, including taxpaying households, public servants, and company employees, who have invested money and effort in the innovation process.

The Theory of Innovative Enterprise as a Regulatory Framework

The theory of innovative enterprise focuses on the existence and interaction of three social conditions—strategic control, organizational integration, and financial commitment—that enable a business firm to manage the uncertain, collective, and cumulative character of the innovation process. Strategic control requires resource-allocation decisions by corporate executives with the abilities and incentives to invest in uncertain innovation processes. Organizational integration enables people with different hierarchical responsibilities and functional capabilities to engage in the collective learning that is the essence of innovation. Financial commitment sustains the innovation process until its cumulative result is a higher-quality, lower-cost product that enables financial returns.

The development, manufacture, and delivery of a safe, effective, accessible, and affordable medicine is an innovation process. As in all cases of industrial innovation, its essence in pharmaceuticals is the organizational learning that is required to create a higher-quality (safer and more effective) product than had previously been available. The availability of a higher-quality product enables the innovative pharmaceutical company to access a larger extent of the market and, depending on the size of accessible demand for the drug, achieve economies of scale in the costs of development, manufacture, and delivery. It is the existence of a higher-quality product that can reap scale economies to achieve a lower unit cost that permits a drug with a regulated price to generate “adequate” corporate profits while delivering the drug at an “affordable” cost to patients.

The task for a government regulator, guided by the Pricing for Medicine Innovation (PMI) framework, is to negotiate with the pharmaceutical industry concerning the relation between profits that are adequate and patient costs that are affordable. A regulatory system of PMI would require that, first and foremost, the responsible government agency recognize the flaws of the pharmaceutical industry’s various arguments against intervention in pricing. In our INET working paper we summarize and rebut the four main arguments against regulated drug pricing put forth by the pharmaceutical industry and its advocates:

Argument 1. High drug prices are needed so that a pharmaceutical company has sufficient profits to fund future drug development.

Argument 2. Expectations of high corporate profits yielded by setting high drug prices incentivize financiers to make the risky investments needed for drug innovation.

Argument 3. New drugs save patients’ lives and therefore provide value for money, even if they are expensive.

Argument 4. Other actors in the supply chain, and not the manufacturers, capture the higher profits from higher drug prices.

Some proponents of lower drug prices have demanded that the Biden administration exercise “march-in rights” contained in the Bayh-Dole Act of 1980, which encourages the licensing of federally funded research to commercial enterprises. It has been suggested that even by threatening to revoke exclusive licenses, the federal government could get pharma companies to think twice about drug-price increases. But this course of action fails to confront the U.S. pharmaceutical industry’s argumentsagainst price regulation. The federal government would be trying to use march-in rights as a form of competition policy to influence the price of a drug without an analytical framework for assessing whether its actions would actually make the drug in question more accessible and affordable.

The theory of innovative enterprise would enable the PMI regulator to mobilize the facts and challenge the assumptions that underpin the industry’s four arguments against price regulation. Our approach confronts the ideological dominance of the “free market” theories that the pharmaceutical industry often invokes in opposition to price regulation. Quite apart from overcoming the enormous political influence of pharmaceutical money, a drug-pricing regulatory agency would have to train personnel in the PMI approach and gain access to company data on which the regulator’s drug-pricing assessment could be based. It is an understatement to say that the creation of a PMI regulatory agency would be challenging, given the political and economic power that the U.S. pharmaceutical industry currently wields. If, however, “Build Back Better” really seeks to chart a course toward a more equitable, inclusive, and sustainable America, PMI offers a path forward for that part of the agenda which seeks medicines that are safer, more effective, more accessible, and more affordable.

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  1. Ignacio

    An innovation soon coming that is really interesting (but nothing that can be deemed as made exclusively by american drug manufacturers, and with many intervening institutions worldwide) is the Car-T treatment for lymphomas. Needless to say: very expensive based on personalized treatment in which your own T-Cells are extracted, modified (activated against the specific lymphoma), cultured and administered. Possibly complementary to mAbs. Whether efficient uses for treatment of difficult solid tumours is still unknown.

    Such treatment would be expensive everywhere but in the US, without Medicare for all, it could be wildly expensive.

    Things slowly improving on this front.

    1. PHlDenizen

      Car-T is a solid intervention for certain subsets of B cell leukemia and lymphomas, but most cancers are solid tumors. It has a long way to get to as front line modality. Covid + CAR T potentiates bad clinical outcomes. With long Covid looking more widespread than the medical establishment will recognize, it’s use may be further limited.

      The truth of the matter is that cancer treatment really hasn’t evolved all that much since chemo. Yes. There is there is radiation that has pinpoint accuracy, but even those interventions have limited use. Lots of declarations that miraculous cancer treatments are just around the corner. But really it all boils down to a game of chicken between chemo drugs and cancer.

      My buddy’s wife ended up having emergency surgery to remove 60 lbs (yes 6-0) of tumor mass and fluid, stemming from her ovaries or uterus. Can’t remember. She coded twice during surgery. And did several rounds of chemo because the fluid has splashed all over her abdomen. Ended up with a hysterectomy. Solid mass tumors are the majority.

  2. PHLDenizen

    One of my ex’s worked at GSK, doing marketing for the infamous Baycol. One thing I learned is that pharma companies think everything can be solved with the right messaging — even clearly dangerous side effects.

    We need to a) ban DTC marketing, b) make stock buybacks illegal again, and c) make it illegal for universities to enter into private-public partnerships to turn their research into billion dollar drugs. If you use taxpayer funded research, there should be a cap on what you can charge. And citizens should get a dividend.

    The US subsidizes drug development for the rest of the world as far as I can tell.

    My buddy also has cystic fibrosis and takes a drug called Trikafta. It’s priced around $311,000 per year. Fortunately his insurance picks it up, as well as the digestive enzymes and pulmozyme. Plus the several week regimen IV antibiotics every year. Connected to an IV stand doing infusions every 4 hours. He has so much scar tissue from the PICC lines they just put a port in.

    My friend would die a very horrible death without the drugs — it expensive to keep him alive. And the CEO of Vertex who clears 10 million a year said she essentially doesn’t care about threats of price controls being a material risk because no one is going to do a damn thing about it.

  3. KLG

    Very true on Car-T, which should be a public good.

    The only way to get a handle on this is for Big Pharma to become the manufacturing sector, highly regulated, after increasing the size of NIH and similar organizations, everywhere, by a factor of three. Maybe more. Repeal the Bayh-Dole Act of 1980, and turn scientists whose “entrepreneurial spirit” is directed at knowledge rather than the “killing” to be made when Big Pharma uses its “research” budget to buy them out.

    1. KLG

      I should have been clearer: Increase the extramural research budget of NIH by a factor of three. And yes, then monitor the academic and research institutions that receive this research support. Such as a Golden Age existed, it was before 1980. Getting grant support was never easy, but serious scientists were successful. And the research funded was broad and fundamental and led to advances across the board. Focused research funded by NIH is frequently wasted, such as a certain “Structural Genomics Initiative” that cost ~$50M IIRC and resulted in less than a handful of protein structures. The expensive and sophisticated infrastructure stayed with the private research institution, though.

  4. MDA

    A new federal agency doesn’t strike me as a solution to any problem, Why not start simple and let the government negotiate prices? The drug companies will squeal like stuck pigs about strangling innovation, but the only way the government doesn’t win that PR war is if they’d really rather not (which is probably the case and depressing to think about). If we wanted true drug innovation, we’d use government funding to pay for drug research (that’s a new agency I could get behind). Profit seeking drug companies start by ruling out anything they can’t patent. I seriously think if a drug company discovered that carrots cured cancer, their top priority would be keeping that story from ever seeing the light of day. A public agency could research and test anything at all they thought held promise, with their only interest being public benefit. They could outsource work to research universities, although personally I’d disqualify any university that accepted corporate money. If all my work went into curing disease for the public benefit, I’d be plenty motivated without needing to be paid a whole lot.

  5. John

    There is no justification for price gouging by anyone, at any time, and under any circumstances. The very phrase speaks to its illicit nature. It is immoral and ought to be criminal.

  6. Telee

    Just a few days Senator Elizabeth Warren held a hearing on financing of Medicare. In her opening statement she dealt with the issues covered in this article as well as the move to privatize Medicare with Direct Contracting Entities (DCE) which she clearly laid the responsibility on Biden telling him to reverse his decision. So now the cat is out of the bag. The 2nd witness was Dr. Susan Weber, president of the Physicians for a National Health Program (PNHP.) In 5 minutes Dr. Weber described the threat to traditional Medicare by DCE. The contact of this hearing was informative and covered a most important issue. Of course there was no coverage that I know of by the corporate news. Here is the link to the hearing.

    https://www.finance.senate.gov/hearings/the-hospital-insurance-trust-fund-and-the-future-of-medicare-financing?eType=EmailBlastContent&eId=eabbed9f-2f13-406b-88f6-5dfd50209aab The hearing starts about 19 minutes into the video.

    The door for the privatization of Medicare was written into the ACA which created the Medicare and Medicaid Innovation Center task with finding new ways of delivering Medicare coverage. These changes can be made without the approval of Congress. Biden appointed Liz Fowler to head the Innovation center and thousands of trials are now occurring all other the US so these changes are now in the process of being implemented.

      1. Telee

        Thanks you Jules, for the correction. I knew better but “misspoke” in my haste writing my comment. Yes, and Dr. Susan Rogers did a great job explaining what was at stake by allowing DCE ( Wall Street ) to stand between the patient and Medicare. But for Wall Street this will represent a windfall of profits ( I’ve seen their presentations on the net salivating over this new market) because they keep 40% the money allotted per patient by Medicare. Keeping the money “saved ” by narrow networks and denial of care is a perverse incentive that Dr. Rogers highlights.

  7. Telee

    Obama opened up two new markets for the financial sector. The privatization of Medicare and the ownership by asset managers such as Blackstone houses ( many supplied by the foreclosures after 2008) that they rent. Biden who supports the changes to Medicare will probably allow more homes to be foreclosed after the pandemic. Biden has also opened up 401ks to Wall Street management. Stephen Schwarzman, CEO of Blackstone said he dreamed of this opportunity. Now we know what Biden discussed when he was a guest of Schwarzman over Thanksgiving.

  8. antidlc

    I don’t know if Mark Cuban’s online pharmacy has been discussed:

    Mark Cuban’s Online Pharmacy Projected To Disrupt The Prescription Drug Market, But With Caveats

    Last week, Mark Cuban Cost Plus Drug Company (MCCPDC) launched an online pharmacy. The launch comes just two months after its pharmacy benefit manager (PBM) operation was established.

    MCCPDC had been a registered pharmaceutical wholesaler for more than a year, but initially it only stocked a handful of drugs. It now purchases more than 100 generic medications directly from manufacturers, bypassing middlemen to substantially lower prices. It is essentially a 503(b) compounding pharmacy, focused on drugs that appear on the Food and Drug Administration’s shortage list.

    There is no question that Mark Cuban’s venture will have an impact, but will it be as disruptive to the prescription drug market as some in the media project? Not initially. The company’s impact on the drug market as a whole will be limited by the number and type (generic) of drugs offered, as well as it being a cash-only system.

    Website and mission statement of costplusdrugs

    Mark Cuban Cost Plus Drug Company’s Online Pharmacy Launches with Lowest Prices on 100 Lifesaving Prescriptions
    As a registered pharmaceutical wholesaler, MCCPDC can bypass middlemen and outrageous markups. The pharmacy’s prices reflect actual manufacturer prices plus a flat 15% margin and pharmacist fee. With the help of digital healthcare company Truepill, patients can expect a seamless, secure e-commerce experience as they navigate the pharmacy’s website, built and powered by Truepill’s digital health platform. Patients will also enjoy reliable prescription fulfillment and delivery through Truepill’s nationwide pharmacy footprint.

    Because the company refuses to pay spread prices to third-party PBMs in order to be allowed to process insurance claims, the online pharmacy will be a cash pay venture. However, its model means patients can immediately purchase a broad array of medications at prices often less than what most insurance plans’ deductible and copay requirements would total.

  9. Stephen V.

    To Yves’ comment about Govt subsidies to R&D from research I did in December from pdf:
    Financialization of Big Pharma–
    In the case of big pharma, “the compensation of shareholders as a percentage of these [R&D] expenses has been growing since the financial crisis of 2007/2008, from 99 per cent in 2006 to 147 per cent in 2018.” The authors of this report ultimately conclude that generation of profits on this scale is “economically fragile and socially unaffordable.” It should also not be surprising to find out that in the U.S., the government funds 40% of all pharma R&D,–in essence subsidizing these increasing payouts to shareholders. Another important factor is that “[O]f the nearly $30 billion that health companies now spend on medical marketing each year, around 68 percent (or about $20 billion) goes to persuading doctors and other medical professionals – not consumers – of the benefits of prescription drugs.”

  10. lovevt

    I read, 20 years ago, the New Republic cover story by Marcia Angell, MD. “America’s Other Drug Problem” New Republic, December 16, 2002. The cover noted America’s other drug problem. Highly recommend it. She wrote “Numerous studies have shown that claims by pharmaceutical companies of the cost of developing new drugs are grossly exaggerated. In fact, over 95% of the basic research is funded by the government and even 50% of new classes of drugs”. New Republic. 12/16/2002, Vol. 227 Issue 25

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