The ‘pill penalty’ that’s worsening American health

on the other hand, inflation control lawsigned in August 2022, focuses primarily on subsidies to invest in clean energy projects and allows governments to price management About certain advanced medical treatments for Medicare patients.

Without good reason, this law discriminates against a class of drugs that are easy to take, do not require a trip to the doctor or hospital, and provide special benefits to disadvantaged patients. You are certainly familiar with this kind of medicine. It’s called a pill.

Under the Inflation Control Act, the government can “negotiate” (a euphemism for “set” because the government is the sole purchaser) the price of small molecule drugs, i.e., pills, tablets, and capsules. 9 years After the Food and Drug Administration approves them.

However, the exemption period is 13 years for biologics or biologics, which are macromolecular drugs that are typically administered as injections or infusions in hospitals or clinics.

This gap, known as the “pill penalty,” is already having a major impact. By giving them another four years to get it back. Average cost is $2 billion When it comes to inventing drugs and bringing them to market, governments have made biologics a much better place for risk capital than pills.

Eli Lilly CEO Dave Ricks The difference is “about 50 to 60 percent of the value,” he said. He added: “In 10 years, the number of small molecules being developed will be far fewer than today.” The company halted development of a small molecule blood cancer drug because the calculations were not working properly.

An August report found that limiting patent terms for small molecule drugs would significantly reduce research and development spending, resulting in “79 fewer” such drugs being developed, resulting in “100 million fewer drugs over the next 20 years.” This would mean a loss of 16 million years of life expectancy. study By Thomas Phillipson, former acting chairman of the Council of Economic Advisers, and five colleagues from the University of Chicago.

Pill penalties also discourage large-scale research and development. rear A drug is approved, allowing for new indications (i.e. treatments for different conditions) for the same drug. Three out of five small molecule cancer drugs are Obtain at least one new indication After initial approval.

According to a survey by PhRMA, a pharmaceutical industry association, 63% of member companies expect to shift Their research and development focuses away from small molecule drugs.

Why should we care? Blocking the discovery of new drugs in pill form will harm the health of all Americans, but, as the Chicago study points out, especially those who are more difficult to obtain an IV infusion outside of their home. It will harm the people anti-inflation laws are meant to help, including marginalized patients. houses.

“Many of these people are unable to travel for regular medical treatment,” said Amy Hinojosa, president of MANA, a national Latino organization. wrote for El Diario. “The cost of treatment is not just the cost of medicine.”

Kevin Kimble“Black Americans are disproportionately likely to live with certain illnesses, but the holy grail of treatment for those illnesses is an easy-to-swallow pill,” said the executive director of the Southern Christian Leadership Policy Institute. are doing.

For example, black or Hispanic account for 70 percent Number of new HIV infections in the United States. One of the major advances in treating this once-death-sentence condition was the one-pill prescription. If pill penalties had been introduced, this might never have happened.

Small molecule therapy includes special abilities Targets processes within cells that allow cancer tumors to grow and spread. 3 out of 5 The most common cancer drugs, such as Revlimid for multiple myeloma, Imbruvica for leukemia, and Ibrance for breast cancer, are given in capsules.

Tablets are also important in treating infections such as: Hepatitis Cneurological conditions and COVID-19 (new coronavirus infection).is more than 30 different small molecule antibiotics Included in the World Health Organization’s list of essential medicines. At a time when antimicrobial resistance is considered a global crisis, the last thing we should do is further penalize the development of these shelf-stable tablets.

But that’s what’s happening. The Biden administration announced the following late last year: First 10 drugs selected For price control. Seven of these are small molecule therapies.

One solution is to eliminate pill penalties by equalizing the exemption period for small molecule drugs and biologics.that’s the purpose invoice Introduced on January 31 by Greg Murphy (RN.C.), Don Davis (DN.C.), and Brett Guthrie (R-Ky.). Securing the path to innovative treatmentsor the EPIC method.

Of course, the worst unintended consequence of the price controls imposed by the Inflation Control Act is that devastating impact Regarding the development of new treatments in general. But for now, Congress can go a long way toward making Americans healthier by simply abolishing pill sentences.

James K. Glassman is a former senior fellow at the American Enterprise Institute and served as Under Secretary of State in 2008 and 2009. He advises healthcare companies and nonprofit organizations.