Regulatory Reform Can Pry Plaque From Americans’ Arteries

Plaque buildup in the arteries is a slow and silent killer, claiming an estimated 700,000 lives in the U.S. per year. Medications such as statins and bempedoic acid have saved millions of lives by reducing the amount of cholesterol produced in the body and in turn slowing – or even reversing – plaque accumulation. The Food and Drug Administration recently took a commendable step to expand anti-cholesterol drug use by allowing manufacturers to target a wider population of patients vulnerable to heart disease. On March 22, drug maker Esperion announced that the FDA approved an unexpectedly large population of at-risk patients to take cholesterol-busting drugs Nexletol and Nexlizet.

However, the FDA can be doing far more to ensure that patients with high cholesterol have easy access to life-saving drugs. Millions of lives can be saved with a more flexible regulatory regime.

Thanks to recent FDA-approved label changes, approximately 40 million patients who do not have cardiovascular disease but suffer from high blood cholesterol levels are now eligible to take cholesterol-lowering therapies such as Nexletol and Nexlizet. Unfortunately, FDA policies around these drugs are still far too restrictive and seriously limit access for vulnerable patients. The agency has long insisted that patients get a script from their doctor before they can have access to statins and similar life-saving medications.

In theory, prescription status is warranted when medication risks are high and/or the treatment regimen is confusing. However, many beneficial drugs are safe and straightforward to use yet are still stuck behind the pharmacist’s desk. And that’s a problem when Americans overwhelmingly use over-the-counter drugs as their first line of defense and rarely see doctors. Doctor’s visits are expensive, embarrassing, and time-consuming, resulting in patients not seeking out the prescriptions they need. An increasing body of evidence shows that statin medications not only significantly reduce the risk of heart attacks, but also reduce “the risk of developing various cancers, and improve … the outcomes for cancer patients.” Meanwhile, side effects are minor and resolve once patients stop treatment. 

Even if regulators are leery of making certain medications completely OTC, they could at least change the system to give more control to patients. Drugs such as statins could be subject to a “one-time prescription rule” in which consumers can purchase the medication freely after an initial consultation/sign-off from their physician. Surely that would be better than the status-quo of constant phone calls and doctor’s visits to authorize refills.

Additionally, the FDA should be more open-minded when it comes to approving anti-cholesterol therapies with proven track records. Red yeast rice (made by fermenting the yeast Monascus purpureus over red rice) has a similar chemical makeup to statins currently on the market and is a key staple of traditional Chinese medicine. Short-duration studies produced by the American Heart Association and University of California, Los Angeles scholars have found similar decreases in blood cholesterol levels between patients on traditional statin therapies and patients consuming red yeast rice. Longer-term studies such as the 41/2-year China coronary secondary prevention study found that these beneficial effects persist over time. Yet, the FDA continues to take a hard line against the medication and forbids manufacturers from marketing it as a drug or dietary supplement.

The agency has concerns about contamination and toxicity in red yeast rice products, but this seems to be a product of its black-market status. According to a 2021 study in Frontiers in Nutrition, “the quality of … [red yeast products] … is dubious and strict quality control should be implemented … More rigorous standardization and monitoring for mycotoxin content must be encouraged to extrapolate data for risk assessment with respect to the prevalence of [the toxin] citrinin.” Allowing companies to sell and market the medication while monitoring for quality control is a far better alternative to prohibition and fearmongering.

The FDA can prevent millions of heart attacks, but not with its current, outdated regulatory framework. A better approach is surely needed to pry the plaque from Americans’ arteries and the regulatory plaque from the FDA.

David Williams is the president of the Taxpayers Protection Alliance.