'Pill punishment' worsens Americans' health

The Anti-Inflation Act, signed into law in August 2022, primarily focuses on subsidies for investments in clean energy projects, but also allows the government to impose price controls on certain advanced medical treatments for Medicare patients. I have to.

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 buyer) the price of small molecule drugs, i.e. pills, tablets and capsules, after as early as nine years. . The Food and Drug Administration has approved 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 the government an additional four years to recoup the average $2 billion cost of inventing and bringing a drug to market, it has made biologics a much better place for risk capital than pills.

Eli Lilly CEO Dave Ricks said the difference is “about 50 to 60 percent of value.” 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.

Limiting patent terms for small molecule drugs would significantly reduce research and development spending, resulting in “79 fewer” such drugs being developed, resulting in “116 million fewer life years over the next 20 years.” According to an August study from the United States, 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 of the five small molecule cancer drugs have gained at least one new indication since their initial approval.

According to a study by PhRMA, a pharmaceutical industry association, 63% of member companies expect to shift their research and development focus 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,” Amy Hinojosa, president of MANA, the national Latino organization, wrote in El Diario. “The cost of treatment is not just the cost of medicine.”

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

For example, blacks and Hispanics account for 70% 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 therapies have the special ability to target processes within cells that allow cancer tumors to grow and spread. Three of the five most popular cancer drugs are administered as capsules. Revlimid for multiple myeloma, Imbruvica for leukemia, and Ibrance for breast cancer.

The tablets are also important in treating infectious diseases such as hepatitis C, neurological disorders, and COVID-19. The World Health Organization's list of essential medicines includes more than 30 different small molecule antibiotics. 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 late last year that it had selected the first 10 items to be subject to price controls. 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 what the paper on January 31st, filed by Greg Murphy (RN.C.), Don Davis (DN.C.), and Brett Guthrie (R-Ky.), called “Innovative Treatments.” This is the purpose of the bill, known as the “Securing Pathways to the Future'' (EPIC Act).

Of course, the worst unintended consequence of the price controls imposed by the Inflation Control Act is their devastating impact on 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.