OPINION:
Americans know all too well the crushing burden of high drug costs. Over the past decade, prescription drug prices have increased more than three times faster than inflation. The indefensible cost of drugs has forced many American families to choose between paying for medicine, rent or food.
That’s why Health and Human Services Secretary Robert F. Kennedy Jr.’s proposal to reduce drug costs, scheduled to be released by Oct. 12, is so important. The Trump administration has made lowering drug prices a top priority, and Mr. Kennedy’s blueprint will play a central role in delivering on that promise.
One of the most effective ways to achieve meaningful savings is to bring more new drugs and more competitors — generic medicines and biosimilars — to market faster, because more supply and more competition mean lower prices.
In 2024 alone, generic drugs and biosimilars saved the U.S. health care system $467 billion. That was why I pledged to increase the federal government’s number of generic drug approvals during my confirmation hearing before I was sworn in as HHS secretary. Historically, expediting their approval has brought down health care costs.
Throughout my tenure, we worked to accelerate the Food and Drug Administration’s approval process for generics, crack down on anticompetitive practices and give patients and doctors more choices. We made a difference, but the unfortunate reality is that many barriers to a competitive and robust drug marketplace have worsened.
Atop the “barriers to competition” list is patent manipulation, which has become the principal reason that more low-cost drugs are not coming to market.
Patent law is supposed to reward true innovation. If a company discovers a brand-new molecule that cures disease, it deserves time-limited exclusivity in the market to recoup its enormous research and clinical trials costs. Some drugmakers have gamed the patent system and turned their limited monopoly into an extended monopoly beyond what Congress intended.
Instead of having just one or two patents, some blockbuster drugs now have more than 100. Over the past two decades, the average number of patents per drug has tripled.
These patents often cover trivial changes, such as altering a pill’s coating. It seems the only reason pharmaceutical companies make these minor changes is to keep their monopoly going beyond the years permitted by Congress. The result, of course, is less drug competition and higher costs for you and me.
The problem isn’t just overpatenting. It’s also how those patents are weaponized in endless court battles.
Pharmaceutical companies frequently file lawsuits they know are weak, not to win in court but to stall their competition. Each new case, which always demands maximum damages and a market-clearing injunction, is intended to intimidate a generic rival, drain resources and delay an affordable competitor’s entry to the market.
In the 1980s, Congress passed the Hatch-Waxman Act, intended to help speed generics to market and promote price competition. The law allows for one lawsuit and 30 months to address patent disputes, with a goal of legal certainty so generics can reach patients quickly.
Unfortunately, over the years, drugmakers have found ways around this law so they can continue gaming the system.
Many companies strategically hold back some patents during their first Hatch-Waxman dispute only to unleash them later in new litigation once the 30-month clock has run its course. They keep filing fresh patents after the initial lawsuit begins, using those later-issued patents as ammunition for new rounds of cases. These predatory delay tactics create an endless loop of litigation, causing us all to pay higher prices at the pharmacy counter.
HHS should work with Congress to amend Hatch-Waxman to prevent this patent manipulation from continuing. This can be done by setting stricter standards for what counts as genuine innovation and capping the number of patents tied to a single product and the number of lawsuits one drugmaker can file against one generic competitor.
Patients deserve access to affordable treatments when exclusivity for one company is supposed to end, not more monopoly pricing manufactured through legal gamesmanship.
The goal must be fairness: a system where competition is real, patients have choices, and no one can rig the rules to entrench monopoly power.
If HHS and Congress take these steps, the Trump administration’s Oct. 12 plan to lower drug costs will prove to be a major victory for the American people.
It’s time for the government to put patients first, restore integrity to the system, and finally deliver the relief families have been waiting for. That’s what President Trump promised, and that’s what the federal government now seems poised to deliver.
• Tom Price served as the 23rd secretary of health and human services.
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