A policy win for Biden that would help us all breathe easier 

In 2019, Kristen Ann Ehrenberger at University of Pittsburgh Medical Center lost one of her patients. It wasn’t the breast cancer she’d been diagnosed with; it was an asthma attack — a footnote on her medical record that could have easily been handled by an inhaler. But Dr. Ehrenberg’s patient couldn’t afford one. 

As the Biden administration begins its negotiations to bring down the price of 10 of the most expensive drugs through the Inflation Reduction Act, it should not forget out-of-control drug prices affecting patient access to other, more mundane treatments, like asthma inhalers. 

Inhalers are not expensive to make. Yet millions of patients struggle to afford them every year — primarily because pharmaceutical companies are gaming a regulatory system that the Food and Drug Administration (FDA) has failed to fix. 

Like many necessary drugs, inhaler prices have increased drastically over the last several decades. Albuterol, the most standard asthma medication — originally developed in 1972 — can cost $100 per inhaler, compared to $15 just ten years ago. Pulmicort, developed in 1973, costs over $175 per inhaler here in the U.S., despite costing $20 abroad. The basic small-molecule medications used to treat asthma — i.e., the actual treatments — have not changed or been improved in decades, but the price keeps going up. 

Pharmaceutical companies have become masters at gaming the FDA’s “Orange Book” to keep inhaler prices high. The FDA requires drug companies to list patents they have for any approved drugs in this Orange Book. If a generic company tries to enter to sell the drug themselves, the manufacturer can sue the generic company, forcing the FDA to automatically block the new company from selling the drug for two and a half years. Without a competitor, the drug company can keep raising prices. 

Drug companies do this all the time, and it’s among the main reasons they’ve been able to keep the prices for asthma inhalers high for decades. What’s worse, in the case of inhalers, the patents they are listing in this Orange Book aren’t even supposed to be there. Rather than patents for improvements of the actual asthma medication or treatment, drug companies are listing patents for minor cosmetic tweaks to the devices delivering asthma medication — the inhalers themselves.  

It’s not legal: federal courts have found it improper to list patents for devices in the Orange Book, not only for inhalers but for other medical devices like insulin injectors. In short, inhalers are expensive because Big Pharma is breaking the law, and the government has not stopped them. 

Lax government enforcement endangers the lives of a large — and politically important — swath of the American public. Around 26 million Americans, almost 8 percent, are diagnosed with asthma, and that incidence is even higher among minority and low-income communities. Primarily due to differences in pollution exposure from geographic segregation and housing policy, almost 12 percent of black children have asthma, compared to less than half that for white children. In Detroit, for example, where asthma rates are higher than the rest of Michigan largely due to air quality differences and pollution (14.6 percent of Detroit children relative to 11.3 percent statewide), asthma also disproportionally falls on black communities within the city. 

The Biden administration has confronted enforcement failures previously to improve healthcare for Americans. Through the 2021 executive order on competition, the administration made hearing aids over-the-counter, lowering their price by as much as $3,000 for as many as 30 million Americans in just over a year. As would be the case with inhalers, this was swift executive action to cut through bureaucratic red tape, where FDA rules requiring prescriptions kept the market for hearing aids in the hands of a few companies charging exorbitant prices. 

In July, President Biden announced the core of his reelection strategy, Bidenomics — the idea that the economy should grow bottom up and expand the middle class, rather than from the top down. This includes a focus on antimonopoly policies to rein in corporate power over the economy. A strategy without clear political wins to show for it, however, will fail to inspire the voters Biden needs to turn out to beat the eventual Republican nominee.  

The generational infrastructure projects promoted by the administration, such as the bipartisan infrastructure law, the Inflation Reduction Act and the CHIPS Act, while hugely impactful, may take time to fully take effect and be felt by voters. By contrast, Biden’s biggest and most popular wins to date have given clear, tangible benefits to everyday Americans, like his initiative on bank junk fees, those annoying extra charges that powerful companies have added onto everything we buy. 

The Biden administration can repeat this success by making inhalers cheap again for the millions of Americans who depend on them. Through swift executive action, he could deliver for working-class Americans by changing FDA regulations to remove all of these bogus device patents from the Orange Book, allowing many other generic companies to enter and bring prices down for inhalers and many other medical devices, such as EpiPens and insulin injectors.

The Federal Trade Commission already has a head start, voting to pass a policy statement to combat improper listing of device patents in the Orange Book on Sept. 14. This is just one example of the sorts of antimonopoly policies that can be a big win for Bidenomics, both in fixing a broken regulatory system to directly reduce consumer prices for critical healthcare and paying political dividends in 2024. 

Dr. Ehrenberger’s patient should not have died for lacking a cheap medication, and nobody else should either. 

Morgan Harper is the director of policy and advocacy at the American Economic Liberties Project. 

Erik Peinert is research manager and editor at the American Economic Liberties Project.